SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE) 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD 01-MAY-2006 THROUGH 31-MAY-2006 DEVICE: MICROMANIPULATION MEDIA SYSTEM, LG HYALURONIDASE AND LG PARAFFIN <GENX> INTL., INC. 510(k) NO: K053551(TRADITIONAL)
ATTN: MICHAEL D CECCHI PHONE NO : 203-453-1700 393 SOUNDVIEW RD. SE DECISION MADE: 09-MAY-06 GUILFORD, CT 06437 510(k) STATEMENT DEVICE: GLOBAL FERTILIZATION, EMBRYO CULTURE AND TRANSFER MEDIA <GENX> INTL., INC. 510(k) NO: K053552(TRADITIONAL)
ATTN: MICHAEL D CECCHI PHONE NO : 203-453-1700 393 SOUNDVIEW RD. SE DECISION MADE: 19-MAY-06 GUILFORD, CT 06437 510(k) STATEMENT DEVICE: TOTAL BILIRUBIN ABBOT LABORATORIES 510(k) NO: K060574(TRADITIONAL)
ATTN: LINDA MORRIS PHONE NO : 972-518-6711 1921 HURD DRIVE SE DECISION MADE: 03-MAY-06 IRVING, TX 75038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARBON DIOXIDE ABBOTT LABORATORIES 510(k) NO: K060295(TRADITIONAL)
ATTN: LINDA MORRIS PHONE NO : 972-518-6711 1921 HURD DR. SE DECISION MADE: 04-MAY-06 IRVING, TX 75038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLUCOSE ABBOTT LABORATORIES 510(k) NO: K060383(TRADITIONAL)
ATTN: LINDA MORRIS PHONE NO : 972-518-6711 1921 HURD DR. SE DECISION MADE: 05-MAY-06 IRVING, TX 75038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RELIENT NAVIGATION DEVICE ACCLARENT, INC. 510(k) NO: K060974(SPECIAL)
ATTN: SU-MIEN CHONG PHONE NO : 650-687-5888 1525-B O'BRIEN DR. SE DECISION MADE: 05-MAY-06 MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCUTECH ENDOLITE PROBE ACCUTECH MEDICAL TECHNOLOGIES, INC510(k) NO: K061025(TRADITIONAL)
ATTN: ANNE WORDEN PHONE NO : 925-895-1200 3637 BERNAL AVE SE DECISION MADE: 31-MAY-06 PLEASANTON, CA 94566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTOFUSER ACE MEDICAL US, LLC 510(k) NO: K060258(TRADITIONAL)
ATTN: ANDY LAMBORNE PHONE NO : 303-443-7500 9102 TURFWAY BEND DR. SE DECISION MADE: 30-MAY-06 POWELL, OH 43065-8497 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACMI DUR-HL LASER SYSTEMS ACMI CORPORATION 510(k) NO: K060752(TRADITIONAL)
ATTN: LORRAINE CALZETTA PHONE NO : 508-804-2752 136 TURNPIKE RD. SE DECISION MADE: 25-MAY-06 SOUTHBOROUGH, MA 01772 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACON AUTOMATIC BLOOD PRESSURE MONITOR KIT, MODEL OB11-111, W/AC ACON LABORATORIES, INC. 510(k) NO: K060925(TRADITIONAL)
ATTN: EDWARD TUNG PHONE NO : 858-535-2030 4108 SORRENTO VALLEY BLVD. SE DECISION MADE: 09-MAY-06 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST; CATALOG# MET0 ACRO BIOTECH LLC. 510(k) NO: K053035(TRADITIONAL)
ATTN: GREGORY LEE PHONE NO : 778-893-7749 9500 7TH STREET UNIT M SE DECISION MADE: 05-MAY-06 RANCHO CUCAMONGA, CA 91730-9094 510(k) STATEMENT DEVICE: ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000 ACRO BIOTECH LLC. 510(k) NO: K060353(TRADITIONAL)
ATTN: GREGORY LEE PHONE NO : 778-322-4651 9500 7TH STREET UNIT M SE DECISION MADE: 03-MAY-06 RANCHO CUCAMONGA, CA 91730-9094 510(k) STATEMENT DEVICE: DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDA AD-TECH MEDICAL INSTRUMENT CORP. 510(k) NO: K053358(ABBREVIATED)
ATTN: GARY SYRING PHONE NO : 608-877-2635 800 LEVANGER LANE SE DECISION MADE: 25-MAY-06 STOUGHTON, WI 53589 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL E AD-TECH MEDICAL INSTRUMENT CORP. 510(k) NO: K053363(ABBREVIATED)
ATTN: GARY SYRING PHONE NO : 608-877-2635 800 LEVANGER LANE SE DECISION MADE: 30-MAY-06 STOUGHTON, WI 53589 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JETSTREAM WORKSPACE ADAC LABORATORIES 510(k) NO: K061029(TRADITIONAL)
ATTN: LORI R PETERSON PHONE NO : 408-468-3042 540 ALDER DR. SE DECISION MADE: 01-MAY-06 MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: S. AUREUS PNA FISH ADVANDX, INC. 510(k) NO: K060099(TRADITIONAL)
ATTN: AMY AUWLES PHONE NO : 781-329-2993 690 CANTON STREET, SUITE 302 SE DECISION MADE: 08-MAY-06 WESTWOOD, MA 02090 510(k) STATEMENT DEVICE: FLIGHT AERO INNOVATIVE RESEARCH, INC. 510(k) NO: K061186(TRADITIONAL)
ATTN: MATT COCHRAN PHONE NO : 316-755-3477 500 W. CLAY ST SE DECISION MADE: 12-MAY-06 VALLEY CENTER, KS 67147 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: COLUMBUS ULTRA CONGRUENT (UC) TIBIAL INSERT/GLIDING SURFACE AESCULAP, INC. 510(k) NO: K053579(SPECIAL)
ATTN: MATTHEW M HULL PHONE NO : 610-984-9072 3773 CORPORATE PKWY. SE DECISION MADE: 17-MAY-06 CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AESCULAP BIPOLAR ACETABULAR CUP AESCULAP, INC. 510(k) NO: K060707(TRADITIONAL)
ATTN: MATTHEW M HULL PHONE NO : 800-258-1946 3773 CORPORATE PKWY. SE DECISION MADE: 31-MAY-06 CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXCIA TOTAL HIP SYSTEM 12/14 TRUNNION WITH CERAMIC HEAD AESCULAP, INC. 510(k) NO: K060918(SPECIAL)
ATTN: KATHY A RACOSKY PHONE NO : 610-984-9291 3773 CORPORATE PARKWAY SE DECISION MADE: 26-MAY-06 CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RINSENDO AIR TECHNIQUES, INC. 510(k) NO: K052271(TRADITIONAL)
ATTN: JOSEPH CAREY PHONE NO : 516-214-5541 70 CANTIAGUE ROCK RD. SE DECISION MADE: 26-MAY-06 HICKSVILLE, NY 11801 510(k) STATEMENT DEVICE: TAP II ANTI-SNORING AND OBSTRUCTIVE SLEEP APNEA ORAL APPLIANCE W AIRWAY MANAGEMENT INC. 510(k) NO: K060388(TRADITIONAL)
ATTN: DARREN HENDERSON PHONE NO : 214-369-0978 6116 NORTH CENTRAL EXPRESSWAY SE DECISION MADE: 17-MAY-06 SUITE 605 510(k) SUMMARY AVAILABLE FROM FDA DALLAS, TX 75206 DEVICE: PARA-PRO FC50 ALPHA-TEC SYSTEMS, INC. 510(k) NO: K053257(TRADITIONAL)
ATTN: RICHARD WILLIAMS PHONE NO : 360-260-2779 12019 N.E. 99TH ST., #1780 SE DECISION MADE: 12-MAY-06 VANCOUVER, WA 98682 510(k) STATEMENT DEVICE: RAPIDTOX AMERICAN BIO MEDICA CORP. 510(k) NO: K053359(SPECIAL)
ATTN: FRAN WHITE PHONE NO : 978-927-3808 163 CABOT ST. SE DECISION MADE: 25-MAY-06 BEVERLY, MA 01915 510(k) STATEMENT DEVICE: ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK AMERICAN DIAGNOSTIC CORP. 510(k) NO: K060321(TRADITIONAL)
ATTN: MICHAEL FALCO PHONE NO : 631-273-9600 55 COMMERCE DR. SE DECISION MADE: 15-MAY-06 HAUPPAUGE, NY 11788 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOLACE POST-OPERATIVE PAIN RELIEF INFUSION SYSTEM APEX MEDICAL TECHNOLOGIES, INC. 510(k) NO: K060933(TRADITIONAL)
ATTN: WHITNEY WILLIAMS PHONE NO : 858-535-0012 10064 MESA RIDGE CT., #202 SE DECISION MADE: 09-MAY-06 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ARCADIA MEDICAL SILICONE WIRE REINFORCED ENDOTRACHEAL TUBES ARCADIA MEDICAL CORPORATION 510(k) NO: K060094(TRADITIONAL)
ATTN: MARK FOOTE PHONE NO : 847-330-4447 1450 EAST AMERICAN LANE SE DECISION MADE: 08-MAY-06 SUITE 1400 510(k) SUMMARY AVAILABLE FROM FDA SCHAUMBURG, IL 60173 DEVICE: PYLO-PLUS ARJ MEDICAL, INC. 510(k) NO: K052708(TRADITIONAL)
ATTN: PHILIP ROSS PHONE NO : 813-855-1557 209 STATE STREET SE DECISION MADE: 01-MAY-06 OLDSMAR, FL 34677 510(k) STATEMENT DEVICE: ARTHREX BIO-COMPRESSION SCREW ARTHREX, INC. 510(k) NO: K060478(TRADITIONAL)
ATTN: ANN WATERHOUSE PHONE NO : 239-643-5553 1370 CREEKSIDE BLVD. SE DECISION MADE: 19-MAY-06 NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO ARTHROCARE PERC-D SPINEWAND ARTHROCARE CORP. 510(k) NO: K061259(SPECIAL)
ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-736-0224 680 VAQUEROS AVE. SE DECISION MADE: 18-MAY-06 SUNNYVALE, CA 94085-3523 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASCENSION PYROSPHERE CMC/TMT ASCENSION ORTHOPEDICS, INC. 510(k) NO: K060560(TRADITIONAL)
ATTN: GLEN NEALLY PHONE NO : 512-836-5001 8700 CAMERON RD., STE. 100 SE DECISION MADE: 05-MAY-06 AUSTIN, TX 78754-3832 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BC100 BODY COMPOSITION ANALYSIS SYSTEM ATHLETIC IQ, INC. 510(k) NO: K060552(TRADITIONAL)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552 5 WHITCOMB AVENUE SE DECISION MADE: 24-MAY-06 AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IVENA VASCULAR PATCH ATRIUM MEDICAL CORP. 510(k) NO: K060396(TRADITIONAL)
ATTN: JOSEPH P DE PAOLO PHONE NO : 603-880-1433 5 WENTWORTH DR. SE DECISION MADE: 12-MAY-06 HUDSON, NH 03051 510(k) STATEMENT DEVICE: HOT DOG PATIENT WARMING SYSTEM AUGUSTINE BIOMEDICAL & DESIGN, LLC510(k) NO: K052392(TRADITIONAL)
ATTN: JAMES D ECKLEIN PHONE NO : 952-465-3500 6581 CITY WEST PARKWAY SE DECISION MADE: 04-MAY-06 EDEN PRAIRIE, MN 55344 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACTIVE UNICOMPARTMENTAL KNEE SYSTEM AUSTRALIAN SURGICAL DESIGN & MANUF510(k) NO: K060412(TRADITIONAL)
ATTN: JAMES F LOGAN PHONE NO : 410-793-0484 2530 RIVA ROAD, SUITE 308 SE DECISION MADE: 17-MAY-06 ANNAPOLIS, MD 21401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DRX9000 TRUE SPINAL DECOMPRESSION SYSTEM AXIOM WORLDWIDE, INC. 510(k) NO: K060735(TRADITIONAL)
ATTN: JIM GIBSON PHONE NO : 813-249-6444 9423 CORPORATE LAKE DRIVE SE DECISION MADE: 26-MAY-06 TAMPA, FL 33634 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ORTHOMON AXON SYSTEMS, INC. 510(k) NO: K061113(TRADITIONAL)
ATTN: HOWARD BAILIN PHONE NO : 631-436-5112 400-2200 OSER AVE. SE DECISION MADE: 23-MAY-06 HAUPPAUGE, NY 11788 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VOXAR 3D ENTERPRISE WITH CARDIAMETRIX BARCOVIEW MIS EDINBURGH 510(k) NO: K061326(TRADITIONAL)
ATTN: NEIL PHILLIPS PHONE NO : 013 147 24792 BONNINGTON BOND, 2 ANDERSON PL SE DECISION MADE: 25-MAY-06 EDINBURGH, LOTHIAN, UNITED KINGDOM510(k) STATEMENT THIRD PARTY REVIEW DEVICE: MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576 BAXTER HEALTHCARE CORPORATION 510(k) NO: K053539(TRADITIONAL)
ATTN: DAVID E CURTIN PHONE NO : 847-473-6079 1620 WAUKEGAN ROAD SE DECISION MADE: 24-MAY-06 MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COULTER LIN-C LINEARITY CONTROL, MODELS 7547065, 723503 BECKMAN COULTER, INC. 510(k) NO: K061064(TRADITIONAL)
ATTN: NANCY NADLER PHONE NO : 305-380-4191 11800 SW 147TH AVE. SE DECISION MADE: 17-MAY-06 MIAMI, FL 33196-2500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM FOR USE WITH THE ANTIMI BECTON DICKINSON & CO. 510(k) NO: K060324(TRADITIONAL)
ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287 7 LOVETON CIR. SE DECISION MADE: 25-MAY-06 SPARKS, MD 21152 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEPHALOTHIN - GN 1 - 64 BECTON, DICKINSON & CO. 510(k) NO: K060558(TRADITIONAL)
ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287 7 LOVETON CIR. SE DECISION MADE: 11-MAY-06 SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PURE-AID PREGNANCY TEST BIO FOCUS CO., LT. 510(k) NO: K053452(TRADITIONAL)
ATTN: LAUREN HONG PHONE NO : 310-532-0009 251E. REDONDO BEACH BLVD. SE DECISION MADE: 25-MAY-06 GARDENA, CA 90248 510(k) STATEMENT DEVICE: FIDIS DSDNA BIOMEDICAL DIAGNOSTICS (BMD) SA 510(k) NO: K060380(TRADITIONAL)
ATTN: CHRISTELLE COURIVAUD PHONE NO : 330 164 621012 ACTIPOLE 25 SE DECISION MADE: 02-MAY-06 4-6 BLD DE BEAUBOURG 510(k) SUMMARY AVAILABLE FROM FDA MARNE LA VALLEE CEDEX 2, FRANCE 77435 DEVICE: VANGUARD REMOVABLE MOLDED POLY TIBIA BIOMET MANUFACTURING CORP. 510(k) NO: K060525(TRADITIONAL)
ATTN: TRACY BICKEL JOHNSON PHONE NO : 574-367-6639 56 EAST BELL DRIVE SE DECISION MADE: 25-MAY-06 PO BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: COMPREHENSIVE PRIMARY SHOULDER STEMS BIOMET MANUFACTURING CORP. 510(k) NO: K060692(TRADITIONAL)
ATTN: SUSAN ALEXANDER PHONE NO : 574-267-6639 PO BOX 587 SE DECISION MADE: 30-MAY-06 56. E. BELL DRIVE 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS WITH PROXIMAL CEMEN BIOMET MANUFACTURING, INC. 510(k) NO: K052639(TRADITIONAL)
ATTN: SUSAN ALEXANDER PHONE NO : 574-267-6639 56 EAST BELL DR. SE DECISION MADE: 03-MAY-06 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOD CHEMISTRY CONTROL BIORESOURCE TECHNOLOGY, INC. 510(k) NO: K060850(TRADITIONAL)
ATTN: ERIKA B AMMIRATI PHONE NO : 650-949-2768 575 SHIRLYNN COURT SE DECISION MADE: 30-MAY-06 LOS ALTOS, CA 94022 510(k) STATEMENT DEVICE: BISCEM TRANSLUCENT, BISCEM OPAQUE BISCO, INC. 510(k) NO: K060701(TRADITIONAL)
ATTN: BENJAMIN LICHTENWALNER PHONE NO : 847-534-6146 1100 WEST IRVING PARK RD. SE DECISION MADE: 15-MAY-06 SCHAUMBURG, IL 60193 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM BLUE SKY BIO, LLC 510(k) NO: K060957(SPECIAL)
ATTN: MICHELLE VOVOLKA PHONE NO : 847-548-8499 888 E BELVIDERE RD. SE DECISION MADE: 05-MAY-06 SUITE 212 510(k) SUMMARY AVAILABLE FROM FDA GRAYSLAKE, IL 60030 DEVICE: ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, BOSTON SCIENTIFIC CORPORATION 510(k) NO: K060323(TRADITIONAL)
ATTN: JENNIFER KIMBALL PHONE NO : 508-683-4178 100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 12-MAY-06 MARLBOROUGH, MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES BRAUN GMBH 510(k) NO: K061199(TRADITIONAL)
ATTN: AMANDA HEFFERNAN PHONE NO : 617-463-9532 800 BOYLSTON ST SE DECISION MADE: 31-MAY-06 PRUDENTIAL TOWER BLDG FL 46 510(k) SUMMARY AVAILABLE FROM FDA BOSTON, MA 02199-8004 DEVICE: BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 30 BREAS MEDICAL AB 510(k) NO: K060546(TRADITIONAL)
ATTN: KARL-JOHAN HOLM PHONE NO : 011 463 1868800 FORETAGSVAGEN 1 SE DECISION MADE: 26-MAY-06 MOLNLYCKE, VASTRA GOTALAND, SWEDEN510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BREAS, MODEL HA01 BREAS MEDICAL AB 510(k) NO: K060790(SPECIAL)
ATTN: KARL-JOHAN HOLM PHONE NO : 463 186 8800 FORETAGSVAGEN 1 SE DECISION MADE: 25-MAY-06 MOLNLYCKE, SWEDEN SE 435 33 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABLE GLOVE, NITRILE BLUE POWDERED EXAMINATION GLOVES BRIGHT ELEMENT SDN BHD 510(k) NO: K061074(TRADITIONAL)
ATTN: SEOW L AUDIE PHONE NO : 033 392 8588 OFF JALAN MERU SE DECISION MADE: 24-MAY-06 KLANG SELANGOR DARUL EHSAN, MALAYS510(k) STATEMENT DEVICE: BRIGHT ELEMENT SND BHD LATEX POWDER FREE EXAMINATION GLOVES BRIGHT ELEMENT SDN BHD 510(k) NO: K061078(TRADITIONAL)
ATTN: SEOW L AUDIE PHONE NO : 033 392 8588 OFF JALAN MERU SE DECISION MADE: 19-MAY-06 KLANG SELANGOR DARUL EHSAN, MALAYS510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR BRYAN KEROPIAN DDS 510(k) NO: K061228(TRADITIONAL)
ATTN: BRYAN KEROPIAN, DDS PHONE NO : 818-881-7233 18607 VENTURA BLVD., SUITE 206 SE DECISION MADE: 26-MAY-06 TARZANA, CA 91356 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO BODYGUARD INFUSION PUMP SYSTEM CAESAREA MEDICAL ELECTRONICS LTD. 510(k) NO: K060479(TRADITIONAL)
ATTN: GALI TZURY PHONE NO : 972 4 6271737 16 SHACHAM STREET SE DECISION MADE: 12-MAY-06 P.O.B. 4294 510(k) SUMMARY AVAILABLE FROM FDA CAESAREA, ISRAEL 38900 DEVICE: CLEARADEX GEL CAMBRIDGEMED 510(k) NO: K060561(TRADITIONAL)
ATTN: PAUL STRATI PHONE NO : 781-376-4114 800 WEST CUMMINGS PARK SE DECISION MADE: 30-MAY-06 SUITE 2900 510(k) STATEMENT WOBURN, MA 01801 DEVICE: MODIFICATION TO POWERHEART ECD CARDIAC SCIENCE CORPORATION 510(k) NO: K060934(SPECIAL)
ATTN: CHERYL SHEA PHONE NO : 425-402-2255 3303 MONTE VILLA PKWY. SE DECISION MADE: 15-MAY-06 BOTHELL, WA 98021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: CARDIMA ABLATION SYSTEM CARDIMA, INC. 510(k) NO: K060715(SPECIAL)
ATTN: ERIC CHAN PHONE NO : 510-354-0176 47266 BENICIA ST. SE DECISION MADE: 15-MAY-06 FREMONT, CA 94538-1372 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDICAL DISPLAY, MODELS MDM 1900-1NG AND MDM 1900-1NR CHILIN TECHNOLOGY CO. LTD 510(k) NO: K061303(TRADITIONAL)
ATTN: PHIL CHEN PHONE NO : 886 6 2794114 NO. 71, TE LUN ROAD SE DECISION MADE: 25-MAY-06 JEN TE HSIAN, TAINAN COUNTY, CHINA510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: 1.3MP MEDICAL COLOR REFERENCE DISPLAY, MODELS MDC 1900-1LG AND M CHILIN TECHNOLOGY CO. LTD 510(k) NO: K061305(TRADITIONAL)
ATTN: PHIL CHEN PHONE NO : 886 6 2794114 NO. 71, TE LUN ROAD SE DECISION MADE: 25-MAY-06 JEN TE HSIAN, TAINAN COUNTY, CHINA510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: AQUASOFT ALL-DAY & ALL-DAY T (HIOXIFILCON A) DAILY WEAR CONTACT CLEARLAB PTE LTD. 510(k) NO: K052290(TRADITIONAL)
ATTN: MARTIN DALSING PHONE NO : 970-243-5490 2214 SANFORD DRIVE, B7 SE DECISION MADE: 15-MAY-06 GRAND JUNCTION, CO 81505 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLINIQA LIQUID QC LIPID CONTROL LEVELS 1 & 2;LINICAL LIPID CALIB CLINIQA CORPORATION 510(k) NO: K061182(TRADITIONAL)
ATTN: CAROL RUGGIERO PHONE NO : 760-744-1900 1432 SOUTH MISSION RD. SE DECISION MADE: 25-MAY-06 FALLBROOK, CA 92028 510(k) STATEMENT DEVICE: CMA CEREBRAL TISSUE MONITORING SYSTEM CMA MICRODIALYSIS AB 510(k) NO: K060554(SPECIAL)
ATTN: NANCY BLANCO PHONE NO : 978-251-1940 73 PRINCETON STREET SE DECISION MADE: 02-MAY-06 NORTH CHELMSFORD, MA 01863 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFIED MERCI RETRIEVER, MODEL 90092 CONCENTRIC MEDICAL, INC. 510(k) NO: K061059(SPECIAL)
ATTN: KIRSTEN VALLEY PHONE NO : 650-938-2100 1380 SHOREBIRD WAY SE DECISION MADE: 25-MAY-06 MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONMED PRO2 PULSE REFLECTANCE OXIMETER, MODEL PRO-M CONMED CORPORATION 510(k) NO: K061112(SPECIAL)
ATTN: IRA DUESLER PHONE NO : 315-624-3072 525 FRENCH ROAD SE DECISION MADE: 22-MAY-06 UTICA, NY 13502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LR-EV COOK VASCULAR, INC. 510(k) NO: K061000(SPECIAL)
ATTN: JIM FERGUSON, JR PHONE NO : 724-845-8621 1186 MONTGOMERY LANE SE DECISION MADE: 10-MAY-06 VANDERGRIFT, PA 15690 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COSMAN CSK RF CANNULA; COSMAN RFK RF CANNULA COSMAN MEDICAL, INC. 510(k) NO: K060799(TRADITIONAL)
ATTN: MICHAEL ARNOLD PHONE NO : 781-272-6561 76 CAMBRIDGE ST. SE DECISION MADE: 02-MAY-06 BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TEMPORARY CROWN & BRIDGE RESIN COSMEDENT, INC. 510(k) NO: K060881(TRADITIONAL)
ATTN: JAMES L SANDRIK PHONE NO : 312-644-9395 401 NORTH MICHIGAN AVE. SE DECISION MADE: 16-MAY-06 SUITE 2500 510(k) SUMMARY AVAILABLE FROM FDA CHICAGO, IL 60611 DEVICE: ACCUREX CYBERMED, INC. 510(k) NO: K061126(TRADITIONAL)
ATTN: SONG NAK CHOI PHONE NO : 82 2 33973970 #504 SJ TECHNOVILLE, SE DECISION MADE: 09-MAY-06 GASAN-DONG 60-19, GEUMCHEON-GU 510(k) SUMMARY AVAILABLE FROM FDA SEOUL, REPUBLIC OF KOREA 153-710 THIRD PARTY REVIEW DEVICE: PHOTOSILK PLUS PULSED LIGHT SYSTEM AND LASER ATTACHMENT CYNOSURE, INC. 510(k) NO: K051442(TRADITIONAL)
ATTN: GEORGE CHO PHONE NO : 978-256-4200 10 ELIZABETH DR. SE DECISION MADE: 24-MAY-06 CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF DADE BEHRING, INC. 510(k) NO: K053337(TRADITIONAL)
ATTN: YUK-TING LEWIS PHONE NO : 302-631-7626 GLASGOW BUSINESS COMMUNITY SE DECISION MADE: 19-MAY-06 BLDG. 500 M.S. 514; POX 6101 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TEST PAK, CALPAK, DILPAK DADE BEHRING, INC. 510(k) NO: K060369(TRADITIONAL)
ATTN: KATHLEEN DRAY-LYON PHONE NO : 781-826-4551 PO BOX 6101 SE DECISION MADE: 04-MAY-06 NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107 DADE BEHRING, INC. 510(k) NO: K060502(TRADITIONAL)
ATTN: YUK-TING LEWIS PHONE NO : 302-631-7626 P.O. BOX 6101 SE DECISION MADE: 18-MAY-06 M/S 514 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: DIMENSION TACR CALIBRATOR, MODEL DC107 DADE BEHRING, INC. 510(k) NO: K060503(TRADITIONAL)
ATTN: YUK-TING LEWIS PHONE NO : 302-631-7626 P.O. BOX 6101 SE DECISION MADE: 18-MAY-06 M/S 514 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO T DADE BEHRING, INC. 510(k) NO: K061020(SPECIAL)
ATTN: LORRAINE H PIESTRAK PHONE NO : 302-631-6279 BLDG 500; M.S. 514 SE DECISION MADE: 10-MAY-06 P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: DIMENSION VISTA CARBON DIOXIDE, CREATININE AND LACTATE DEHYDROGE DADE BEHRING, INC. 510(k) NO: K061238(SPECIAL)
ATTN: LORRAINE H PIESTRAK PHONE NO : 302-631-6279 P.O. BOX 6101 SE DECISION MADE: 25-MAY-06 M/S 514 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR DADE BEHRING, INC. 510(k) NO: K061251(TRADITIONAL)
ATTN: LORRAINE H PIESTRAK PHONE NO : 302-631-6279 BLDG 500; M.S. 514 SE DECISION MADE: 31-MAY-06 P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: ELLIPSE 12PL, MODEL 9ESL7228 DANISH DERMATOLOGIC DEVELOPMENT A/510(k) NO: K060516(ABBREVIATED)
ATTN: OLE KOFOD PHONE NO : 454 576 8808 AGERN ALLE 11 SE DECISION MADE: 15-MAY-06 HOERSHOLM, DENMARK DK-2970 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TURKOM-CERA DENTAL SUPPLIERS OF AMERICA, INC. 510(k) NO: K060860(TRADITIONAL)
ATTN: DAN WATSON PHONE NO : 360-474-9882 18616 123RD. AVENUE NE SE DECISION MADE: 19-MAY-06 ARLINGTON, WA 98223 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABSOANCHOR MICROIMPLANT DENTOS INC. 510(k) NO: K060126(TRADITIONAL)
ATTN: ANNA SHAFTO PHONE NO : 734-763-5758 1011 N. UNIVERSITY AVENUE SE DECISION MADE: 16-MAY-06 ANN ARBOR, MI 48109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TEMPFX ESTHETIC PROVISIONAL SYSTEM DENTSPLY INTERNATIONAL, INC. 510(k) NO: K061264(SPECIAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511 221 W. PHILADELPHIA ST., SE 60 SE DECISION MADE: 23-MAY-06 SUSQUEHANNA COMMERCE CTR. 510(k) SUMMARY AVAILABLE FROM FDA YORK, PA 17404 DEVICE: SPIRALOK ANCHOR DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K060271(TRADITIONAL)
ATTN: RUTH FORSTADT PHONE NO : 508-977-3988 325 PARAMONT DRIVE SE DECISION MADE: 04-MAY-06 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RC LOOP /DUAL ORTHOCORD SUTURE,RC LOOP W/ETHIBOND SUTURE,RC LOOP DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K060553(SPECIAL)
ATTN: KRISTINE CHRISTO PHONE NO : 508-828-3359 325 PARAMONT DRIVE SE DECISION MADE: 04-MAY-06 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEPUY SOLUTION SYSTEM HIP PROSTHESIS DEPUY ORTHOPAEDICS, INC. 510(k) NO: K060581(SPECIAL)
ATTN: ANNE M SCHULER PHONE NO : 574-372-7098 700 ORTHOPAEDIC DR. SE DECISION MADE: 19-MAY-06 P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0988 DEVICE: MEMORY STAPLE DEPUY ORTHOPAEDICS, INC. 510(k) NO: K060746(TRADITIONAL)
ATTN: RHONDA MYER PHONE NO : 574-371-4927 700 ORTHOPAEDIC DR. SE DECISION MADE: 25-MAY-06 WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLYAX LOCKED PLATING SYSTEM DEPUY ORTHOPAEDICS, INC. 510(k) NO: K060969(TRADITIONAL)
ATTN: RHONDA MYER PHONE NO : 574-371-4927 700 ORTHOPAEDIC DR. SE DECISION MADE: 12-MAY-06 WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STA-CEPHASCREEN KIT DIAGNOSTICA STAGO, INC. 510(k) NO: K053111(TRADITIONAL)
ATTN: JIM BARROW PHONE NO : 973-631-1200 5 CENTURY DR. SE DECISION MADE: 04-MAY-06 PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DVTCARE CA5 DOCTORS ORDERS 510(k) NO: K061125(TRADITIONAL)
ATTN: JERRY KULAS PHONE NO : 616-931-9939 731 B CONSTRUCTION CT. SE DECISION MADE: 23-MAY-06 ZEELAND, MI 49464 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM, MODEL DK7788 DUCKWORTH & KENT, LTD. 510(k) NO: K060995(TRADITIONAL)
ATTN: MARTIN LOCK PHONE NO : 011 441 462893254 7 MARQUIS BUSINESS CENTRE SE DECISION MADE: 22-MAY-06 ROYSTON RD. 510(k) STATEMENT BALDOCK, HERTFORDSHIRE, UNITED KINGDOM SG7 6XL DEVICE: EAGLEVISION GELLANSERTS, MODEL REF 0040 EAGLE VISION, INC. 510(k) NO: K053333(TRADITIONAL)
ATTN: JEFF COBB PHONE NO : 901-380-7000 8500 WOLF LAKE DR. SE DECISION MADE: 02-MAY-06 SUITE 110 510(k) SUMMARY AVAILABLE FROM FDA MEMPHIS, TN 38133 DEVICE: EBI OPTILOCK PERIARTICULAR PLATING SYSTEM EBI, L.P. 510(k) NO: K061098(TRADITIONAL)
ATTN: JENNIFER P HARAKAL PHONE NO : 973-299-9300 100 INTERPACE PKWY. SE DECISION MADE: 24-MAY-06 PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BACSTOP ELCAM MEDICAL A.C.A.L. 510(k) NO: K053405(TRADITIONAL)
ATTN: TALI HAZAN PHONE NO : 972 469 88875 KIBBUTZ BAR-AM SE DECISION MADE: 11-MAY-06 D.N. MEROM HAGALIL, ISRAEL 13860 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ESTECH AORTIC EASY FLOW CANNULA ENDOSCOPIC TECHNOLOGIES, INC. 510(k) NO: K060101(TRADITIONAL)
ATTN: CRAIG COOMBS PHONE NO : 510-337-0140 1193 SHERMAN STREET SE DECISION MADE: 10-MAY-06 ALAMEDA, CA 94501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENPATH MEDICAL STEERABLE SHEATH ENPATH MEDICAL, INC. 510(k) NO: K061119(SPECIAL)
ATTN: JAMES JENKINS PHONE NO : 763-577-2258 15301 HWY. 55 WEST SE DECISION MADE: 18-MAY-06 MINNEAPOLIS, MN 55447 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSURE II ENTERIX INC. 510(k) NO: K060930(SPECIAL)
ATTN: EDWIN DIAZ PHONE NO : 732-429-1899 236 FERNWOOD AVE. SE DECISION MADE: 04-MAY-06 EDISON, NJ 08837 510(k) STATEMENT DEVICE: MYLAB30, 50, 70 AND 90 SYSTEMS ADDITION OF 3D/4D, MODELS 7300, 7 ESAOTE, S.P.A. 510(k) NO: K060827(TRADITIONAL)
ATTN: CARRI GRAHAM PHONE NO : 317-569-9500 11460 N MERIDIAN ST., STE 150 SE DECISION MADE: 19-MAY-06 CARMEL, IN 46032 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: G-SCAN-MODEL 9800020000, E-SCAN MODEL 9800010000 AND E-SCAN XQ-M ESAOTE, S.P.A. 510(k) NO: K060956(SPECIAL)
ATTN: CARRI GRAHAM PHONE NO : 317-569-9500 11460 N MERIDIAN ST., STE 150 SE DECISION MADE: 04-MAY-06 CARMEL, IN 46032 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRYOSHAPE ETGAR GROUP H.M.Y.A. LTD. 510(k) NO: K060928(TRADITIONAL)
ATTN: BENNY ARAZY PHONE NO : 097 665 613 37A ROTHSCHILD ST., 44449 SE DECISION MADE: 22-MAY-06 KFAR-SABA, ISRAEL 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROCEED SURGICAL MESH ETHICON INC. 510(k) NO: K060713(TRADITIONAL)
ATTN: SERGIO J GADALETA PHONE NO : 908-218-3102 ROUTE 22 WEST SE DECISION MADE: 25-MAY-06 PO BOX 151 510(k) SUMMARY AVAILABLE FROM FDA SOMERVILLE, NJ 08876 DEVICE: EUROMED SURESKIN III WITH SILVER WOUND DRESSINGS EUROMED, INC. 510(k) NO: K050032(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434 49 PLAIN ST. SE DECISION MADE: 17-MAY-06 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHETIC VINYL PATIENT EXAMINATION GLOVE-POWERED EVER LIGHT PLASTIC PRODUCTS CO., L510(k) NO: K060784(TRADITIONAL)
ATTN: KATHY LIU PHONE NO : 909-591-7888 3973 SCHAEFER AVE SE DECISION MADE: 01-MAY-06 CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVE-POWDER FREE EVER LIGHT PLASTIC PRODUCTS CO., L510(k) NO: K060786(TRADITIONAL)
ATTN: KATHY LIU PHONE NO : 909-591-7888 3973 SCHAEFER AVE SE DECISION MADE: 08-MAY-06 CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AN FISHER DIAGNOSTICS 510(k) NO: K052308(TRADITIONAL)
ATTN: M. HEATHER CAMERON PHONE NO : 540-869-8163 8365 VALLEY PIKE SE DECISION MADE: 10-MAY-06 MIDDLETOWN, VA 22645-0307 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, M FOXHOLLOW TECHNOLOGIES, INC. 510(k) NO: K061063(SPECIAL)
ATTN: MELISSA MURPHY PHONE NO : 650-421-8579 740 BAY ST. SE DECISION MADE: 18-MAY-06 REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIPOD FREEDOM DESIGNS, INC. 510(k) NO: K060926(TRADITIONAL)
ATTN: BOB GARDNER PHONE NO : 805-582-0077 2241 MADERA RD. SE DECISION MADE: 19-MAY-06 SIMI VALLEY, CA 93065 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARCHITECT BNP ASSAY, MODEL 8K28 FUJIREBIO DIAGNOSTICS, INC. 510(k) NO: K060964(TRADITIONAL)
ATTN: DIANA L WOLANIUK PHONE NO : 610-240-3917 201 GREAT VALLEY PKWY. SE DECISION MADE: 25-MAY-06 MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FUTURE MOBILITY HEALTHCARE INC. ORION II WHEELCHAIR AND STELLATO FUTURE MOBILITY HEALTHCARE INC. 510(k) NO: K061010(TRADITIONAL)
ATTN: WILLIAM SALTER PHONE NO : 905 671 1661 2775 SLOUGH STR SE DECISION MADE: 23-MAY-06 MISSISSAUGA, ON, CANADA L4T 1G2 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: G.USBAMP G.TEC MEDICAL ENGINEERING GMBH 510(k) NO: K060803(TRADITIONAL)
ATTN: CHRISTOPH GUGER PHONE NO : 725 122 24012 SIERNINGSTRASSE 14 SE DECISION MADE: 02-MAY-06 SCHIEDLBERG, AUSTRIA 4521 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE05A AND L GE HEALTHCARE 510(k) NO: K061185(SPECIAL)
ATTN: JOEL KENT PHONE NO : 781-449-8685 86 PILGRIM ROAD SE DECISION MADE: 15-MAY-06 NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDIQ FUSION GE HEALTHCARE 510(k) NO: K061370(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894 3000 N. GRANDVIEW BLVD. SE DECISION MADE: 30-MAY-06 MAILSTOP W-440 510(k) SUMMARY AVAILABLE FROM FDA WAUKESHA, WI 53188 THIRD PARTY REVIEW DEVICE: CENTRICITY AW SUITE OPTION GE HEALTHCARE INFORMATION TECHNOLO510(k) NO: K061372(TRADITIONAL)
ATTN: RHODA VALERA PHONE NO : 847-277-6092 540 W. NW HIGHWAY SE DECISION MADE: 30-MAY-06 BARRINGTON, IL 60010 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: GE LOGIQ P5 AND A5 GENERAL ELECTRIC CO. 510(k) NO: K060993(SPECIAL)
ATTN: ALLEN SCHUH PHONE NO : 414-721-3992 P.O. BOX 414 SE DECISION MADE: 03-MAY-06 MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GIVEN DIAGNOSTIC SYSTEM GIVEN IMAGING LTD. 510(k) NO: K053639(TRADITIONAL)
ATTN: SHOSHANA FRIEDMAN PHONE NO : 011 972 49097784 NEW INDUSTRIAL PARK SE DECISION MADE: 08-MAY-06 P.O. BOX 258 510(k) SUMMARY AVAILABLE FROM FDA YOQNEAM, ISRAEL 20692 DEVICE: MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM GIVEN IMAGING LTD. 510(k) NO: K060805(SPECIAL)
ATTN: SHOSHANA FRIEDMAN PHONE NO : 011 972 49097784 SHAAR YOKNEAM SE DECISION MADE: 24-MAY-06 NEW INDUSTRIAL ZONE, 510(k) SUMMARY AVAILABLE FROM FDA YOKNEAM (P.O.BOX 258), ISRAEL 20692 DEVICE: XPAND RADIOLUCENT CORPECTOMY SPACER GLOBUS MEDICAL INC. 510(k) NO: K060665(SPECIAL)
ATTN: KELLY J BAKER PHONE NO : 610-415-9000 303 SCHELL LN. SE DECISION MADE: 10-MAY-06 PHOENIXVILLE, PA 19460 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPEECHLINK 100 TYPE 1053 GN OTOMETRICS A/S 510(k) NO: K061104(TRADITIONAL)
ATTN: PER PAPE THOMSEN PHONE NO : 45 721 11555 DYBENDALSVAENGET 2 SE DECISION MADE: 03-MAY-06 P.O. BOX 119 510(k) SUMMARY AVAILABLE FROM FDA TAASTRUP, DENMARK DK-2630 THIRD PARTY REVIEW DEVICE: HI-TORQUE ADVANCE AND ADVANCE LITE GUIDE WIRE GUIDANT CORPORATION 510(k) NO: K060449(TRADITIONAL)
ATTN: JENNIFER PAE RIGGS PHONE NO : 951-914-4581 26531 YNEZ ROAD SE DECISION MADE: 30-MAY-06 TEMECULA, CA 92591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HAEMONETICS 40U RBC FILTER BAG HAEMONETICS CORP. 510(k) NO: K061103(TRADITIONAL)
ATTN: GABRIEL J MURACA PHONE NO : 781-356-9553 400 WOOD RD. SE DECISION MADE: 17-MAY-06 P.O. BOX 9114 510(k) SUMMARY AVAILABLE FROM FDA BRAINTREE, MA 02184 THIRD PARTY REVIEW DEVICE: DEPILITE EL-8B SERIES DERMO FLASH SYSTEMS HAIR INTERNATIONAL SYSTEMS USA, IN510(k) NO: K052371(TRADITIONAL)
ATTN: CRAIG A MITCHELL PHONE NO : 949-250-9066 4590 MACARTHER BLVD., STE. 500 SE DECISION MADE: 04-MAY-06 NEWPORT BEACH, CA 92692-2028 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROBERTSITE STOPCOCK HALKEY-ROBERTS CORP. 510(k) NO: K061143(TRADITIONAL)
ATTN: RADAMES PIERANTONI PHONE NO : 727-577-1300 11600 M.L. KING BLVD.,NORTH SE DECISION MADE: 10-MAY-06 ST. PETERSBURG, FL 33716 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: HEALTH LINE INTERNATIONAL CORPORATIONS,S IV ADMINISTRATIVE SETS HEALTH LINE INTERNATIONAL CORPORAT510(k) NO: K060352(TRADITIONAL)
ATTN: JACK SPEER PHONE NO : 801-773-2529 FREEPORT CENTER BLDG E-13 DR 2 SE DECISION MADE: 31-MAY-06 PO BOX 160435 510(k) SUMMARY AVAILABLE FROM FDA CLEARFIELD, UT 84016-0435 DEVICE: ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP HELENA LABORATORIES 510(k) NO: K061014(SPECIAL)
ATTN: PATRICIA FRANKS PHONE NO : 409-842-3714 1530 LINDBERGH DR. SE DECISION MADE: 10-MAY-06 P.O. BOX 752 510(k) SUMMARY AVAILABLE FROM FDA BEAUMONT, TX 77704-0752 DEVICE: MONDIAL HERAEUS KULZER, INC. 510(k) NO: K060994(TRADITIONAL)
ATTN: CHERYL V ZIMMERMAN PHONE NO : 574-299-6662 4315 SOUTH LAFAYETTE BLVD. SE DECISION MADE: 22-MAY-06 SOUTH BEND, IN 46614 510(k) STATEMENT DEVICE: HOMMED CENTRAL STATION, VERSION 3.5 HONEYWELL HOMMED LLC 510(k) NO: K053453(TRADITIONAL)
ATTN: TOMMIE J MORGAN PHONE NO : 713-880-5111 2018 NORTH DURHAM DRIVE SE DECISION MADE: 05-MAY-06 HOUSTON, TX 77008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGICAL FACE MASK HONG YA NON-WOVEN PRODUCTS CO., LT510(k) NO: K060776(TRADITIONAL)
ATTN: KATHY LIU PHONE NO : 909-591-7888 3973 SCHAEFER AVE. SE DECISION MADE: 25-MAY-06 CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AXSOS PLUS LOCKING PLATE SYSTEM HOWMEDICA OSTEONICS CORP. 510(k) NO: K061012(TRADITIONAL)
ATTN: FRANCISCO HARO PHONE NO : 201-831-5493 325 CORPORATE DRIVE SE DECISION MADE: 19-MAY-06 MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MIDLITE C SERIES COMPRESSION TOOL AND HANDPIECE ATTACHMENT ACCES HOYA CONBIO, INC 510(k) NO: K060977(TRADITIONAL)
ATTN: LIZA BURNS PHONE NO : 209-586-0416 19722 WESTVIEW DRIVE SE DECISION MADE: 24-MAY-06 TWAIN HARTE, CA 95373 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALPHASPHERE ORBITAL IMPLANT HYDRON PTY LIMITED 510(k) NO: K053298(TRADITIONAL)
ATTN: JUDY F GORDON PHONE NO : 949-715-0609 733 BOLSANA DRIVE SE DECISION MADE: 09-MAY-06 LAGUNA BEACH, CA 92651 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6 HYPHEN BIOMED 510(k) NO: K050367(TRADITIONAL)
ATTN: OLA ANDERSON PHONE NO : 513-770-1993 6560 GOVE CT. SE DECISION MADE: 24-MAY-06 MASON, OH 45040 510(k) STATEMENT DEVICE: IMMUGLO ANTI-ENDOMYSIAL ANTIBODY IFA IMMCO DIAGNOSTICS, INC. 510(k) NO: K060157(TRADITIONAL)
ATTN: KEVIN LAWSON PHONE NO : 716-691-0091 60 PINEVIEW DR. SE DECISION MADE: 25-MAY-06 BUFFALO, NY 14228-2120 510(k) STATEMENT DEVICE: LEGACY ABUTMENT SYSTEM IMPLANT DIRECT LLC 510(k) NO: K060063(TRADITIONAL)
ATTN: ROSEMARIE MASTELLER PHONE NO : 818-444-3323 27030 MALIBU HILLS RD. SE DECISION MADE: 19-MAY-06 CALABASAS HILLS, CA 91301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROVIDE TEMPORARY CYLINDER IMPLANT INNOVATIONS, INC. 510(k) NO: K061177(SPECIAL)
ATTN: JIM BANIC PHONE NO : 561-776-6932 4555 RIVERSIDE DR. SE DECISION MADE: 16-MAY-06 PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISCON DAILY (ETAFILCON A) ONE-DAY SOFT (HYDROPHILIC) CONTACT LE INNOVA VISION INC. 510(k) NO: K053191(SPECIAL)
ATTN: JENNIFER REICH PHONE NO : 928-773-9488 2904 N. BOLDT DRIVE SE DECISION MADE: 12-MAY-06 FLAGGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IGS VAGINAL SPECULUM INNOVATIVE GYNECOLOGICAL SOLUTIONS510(k) NO: K060129(TRADITIONAL)
ATTN: JOSEPH P PAOLO PHONE NO : 603-880-1433 5 WENTWORTH DRIVE SE DECISION MADE: 04-MAY-06 HUDSON, NH 03051 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSPIRSTAR GLOVE ELECTRODE INSPIRSTAR, INC. 510(k) NO: K061343(TRADITIONAL)
ATTN: NING WU PHONE NO : 480-634-8708 891 N. NAPLES DR. SE DECISION MADE: 31-MAY-06 CHANDLER, AZ 85226 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: HEMOSIL PT-FIBRINOGEN HS PLUS INSTRUMENTATION LABORATORY CO. 510(k) NO: K060931(SPECIAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467 113 HARTWELL AVE. SE DECISION MADE: 02-MAY-06 LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT INTEGRA LIFESCIENCES CORP. 510(k) NO: K053244(SPECIAL)
ATTN: JON CAPAROTTA PHONE NO : 609-936-2495 311 ENTERPRISE DRIVE SE DECISION MADE: 10-MAY-06 PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DPOAE20 , ECLIPSE INTERACOUSTICS A/S, ASSENS 510(k) NO: K060539(TRADITIONAL)
ATTN: DANIEL EGGAN PHONE NO : 952-278-4457 7625 GOLDEN TRIANGLE DRIVE SE DECISION MADE: 30-MAY-06 EDEN PRAIRIE, MN 55344 510(k) STATEMENT DEVICE: INTUITIVE SURGICAL ENDOWRIST PK DISSECTING FORCEPS, MODELS 40021 INTUITIVE SURGICAL, INC. 510(k) NO: K061260(SPECIAL)
ATTN: MICHAEL H YRAMATEGUI PHONE NO : 408-523-2100 950 KIFER RD. SE DECISION MADE: 18-MAY-06 SUNNYVALE, CA 94086-5206 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IRIDEX OTOPROBE LONG AND SHORT ANGLES, P/N 14310-1 AND 14320-1 IRIDEX CORP. 510(k) NO: K060905(TRADITIONAL)
ATTN: JOHN JOSSY PHONE NO : 650-962-8848 1212 TERRA BELLA AVE. SE DECISION MADE: 31-MAY-06 MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PEDIATRIC SUBDERMAL WIRE ELECTRODE (PSWE) IVES EEG SOLUTIONS, INC. 510(k) NO: K060189(TRADITIONAL)
ATTN: JOHN IVES PHONE NO : 613 692 1567 6325 RIDEAU VALLEY DRIVE SE DECISION MADE: 30-MAY-06 MANOTICK, ONTARIO, CANADA K4M 1B3 510(k) STATEMENT DEVICE: CONDYLAFORM II NFC IVOCLAR VIVADENT, INC. 510(k) NO: K060565(TRADITIONAL)
ATTN: DONNA M HARTNETT PHONE NO : 716-691-0010 175 PINEVIEW DR. SE DECISION MADE: 08-MAY-06 AMHERST, NY 14228 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) JIANGSU EVERYGUARD PLASTIC PRODUCT510(k) NO: K060909(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441 RM 1606 BLDG 1JIANZIANG YUAN SE DECISION MADE: 24-MAY-06 NO 209 BEI SI HUAN SHONG RD HA 510(k) SUMMARY AVAILABLE FROM FDA BEIJING, CHINA 100083 DEVICE: INFREX JOHARI DIGITAL HEALTHCARE LTD. 510(k) NO: K060246(TRADITIONAL)
ATTN: POOJA JOHARI PHONE NO : 818 888 8520 7131 FARRALONE AVE, #48, SE DECISION MADE: 05-MAY-06 CANOGA PARK, CA 91303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JUNIPER COOLING DEVICE JUNIPER MEDICAL TECHNOLOGY, INC 510(k) NO: K060407(TRADITIONAL)
ATTN: ROSEMARY HARRY PHONE NO : 206-390-5583 7139 KOLL PARKWAY SUITE 300 SE DECISION MADE: 31-MAY-06 PLEASANTON, CA 94566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: K-JUMP DIGITAL THERMOMETER WITH BATTERY-LESS PATCH, MODEL KD-210 K-JUMP HEALTH CO., LTD. 510(k) NO: K060240(ABBREVIATED)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502 55 NORHTERN BLVD. SE DECISION MADE: 19-MAY-06 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DENALI DEFORMITY SYSTEM K2M, LLC 510(k) NO: K052404(TRADITIONAL)
ATTN: RICHARD W WOODS PHONE NO : 703-777-3155 751 MILLER DRIVE SE, SUITE F1 SE DECISION MADE: 23-MAY-06 LEESBURG, VA 20175 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PYRENEES CERVICAL PLATE SYSTEM K2M, LLC 510(k) NO: K060442(TRADITIONAL)
ATTN: RICH WOODS PHONE NO : 703-777-3155 751 MILLER DR.,S.E., SUITE F1 SE DECISION MADE: 15-MAY-06 LEESBURG, VA 20175 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VANTAGE INDIRECT OPHTHALMOSCOPE KEELER INSTRUMENTS, INC. 510(k) NO: K060822(SPECIAL)
ATTN: EUGENE R VANARSDALE PHONE NO : 610-353-4350 456 PKWY. SE DECISION MADE: 23-MAY-06 BROOMALL, PA 19008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOBLANKET SURGICAL MESH KENSEY NASH CORPORATION 510(k) NO: K061030(SPECIAL)
ATTN: DEBORAH RACIOPPI PHONE NO : 610-594-4389 735 PENNSYLVANIA DRIVE SE DECISION MADE: 09-MAY-06 EXTON, PA 19341 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KIMBERLY-CLARK IMPERVIOUS COMFORT GOWN KIMBERLY-CLARK CORP. 510(k) NO: K052824(TRADITIONAL)
ATTN: CHERYL M SANZARE PHONE NO : 770-587-7131 1400 HOLCOMB BRIDGE RD. SE DECISION MADE: 02-MAY-06 ROSWELL, GA 30076 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANCHOR PLUS/NEO ANCHOR PLUS KJ MEDITECH 510(k) NO: K053629(TRADITIONAL)
ATTN: CHARLIE MACK PHONE NO : 931-937-8093 340 SHADY GROVE ROAD SE DECISION MADE: 31-MAY-06 FLINTVILLE, TN 37335 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KONICA MINOLTA PULSOX-300, 300I KONICA MINOLTA SENSING, INC. 510(k) NO: K053419(TRADITIONAL)
ATTN: NANCI DEXTER PHONE NO : 303-359-9791 2703 JOSEPHINE ST. SE DECISION MADE: 11-MAY-06 DENVER, CO 80205 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE,WHITE (NON-COLORED KOSSAN LATEX INDUSTRIES (M) SDN. B510(k) NO: K060771(TRADITIONAL)
ATTN: LIM K HWA PHONE NO : 603 339 27616 LOT 16632, 5-1/4 MILES, SE DECISION MADE: 01-MAY-06 JALAN MERU 510(k) STATEMENT KLANG, SELANGOR, MALAYSIA 41050 DEVICE: POWDER-FREE LATEX PATIENT EXAMINATION GLOVE,WITH EXTRACTABLE PRO KOSSAN LATEX INDUSTRIES (M) SDN. B510(k) NO: K060775(TRADITIONAL)
ATTN: LIM K HWA PHONE NO : 603 339 27616 LOT 16632, 5-1/4 MILES, SE DECISION MADE: 16-MAY-06 JALAN MERU 510(k) STATEMENT KELANG, SELANGOR, MALAYSIA 41050 DEVICE: EYE SEE MULTIPURPOSE, NO-RUB CONTACT LENS SOLUTION LAPIS LAZULI, NV 510(k) NO: K051104(TRADITIONAL)
ATTN: MARTIN DALSING PHONE NO : 970-243-5490 623 GLACIER DRIVE SE DECISION MADE: 31-MAY-06 GRAND JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFE SPINE CEMENT RESTRICTOR LIFE SPINE 510(k) NO: K060247(TRADITIONAL)
ATTN: ERIN MALLOY PHONE NO : 847-884-6117 2400 HASSELL ROAD SE DECISION MADE: 11-MAY-06 SUITE 370 510(k) SUMMARY AVAILABLE FROM FDA HOFFMAN ESTATES, IL 60195 DEVICE: SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD LIFECORE BIOMEDICAL, INC. 510(k) NO: K060530(TRADITIONAL)
ATTN: RACHEL KENNEDY PHONE NO : 952-368-4300 3515 LYMAN BLVD. SE DECISION MADE: 22-MAY-06 CHASKA, MN 55318 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEM LIFESCAN, INC. 510(k) NO: K061118(SPECIAL)
ATTN: MARY ELLEN HOLDEN PHONE NO : 408-942-3589 1000 GIBRALTAR DR. SE DECISION MADE: 19-MAY-06 MILPITAS, CA 95035-6312 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, SAGGITAL SAW, RECIPR LINVATEC CORP. 510(k) NO: K060198(SPECIAL)
ATTN: ELIZABETH PAUL PHONE NO : 727-399-5234 11311 CONCEPT BLVD. SE DECISION MADE: 11-MAY-06 LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MANI NEEDLE & SUTURE PACK (NYLON) MANI, INC. 510(k) NO: K053637(TRADITIONAL)
ATTN: DAVID J BLOCH PHONE NO : 202-414-9209 1301K STREET, N.W. SE DECISION MADE: 19-MAY-06 SUITE 1100 - EAST TOWER 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20005-3373 DEVICE: MANI NEEDLE & SUTURE PACK (SILK) MANI, INC. 510(k) NO: K053638(TRADITIONAL)
ATTN: DAVID J BLOCH PHONE NO : 202-414-9209 1301K STREET, N.W. SE DECISION MADE: 19-MAY-06 SUITE 1100 - EAST TOWER 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20005-3373 DEVICE: ROTAFLOW CENTRIFUGAL PUMP WITH SAFELINE COATING, MODEL BSQ-RF-32 MAQUET CARDIOPULMONARY AG 510(k) NO: K061072(TRADITIONAL)
ATTN: KATRIN SCHWENKGIENKS PHONE NO : 011 497 4789210 HECHINGER STRASSE 38 SE DECISION MADE: 23-MAY-06 HIRRLINGEN, GERMANY 72145 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3MATIC MATERIALISE N.V. 510(k) NO: K060950(TRADITIONAL)
ATTN: CARL VAN LIERDE PHONE NO : 32 163 96714 15 TECHNOLOGIELAAN SE DECISION MADE: 18-MAY-06 LEUVEN, BELGIUM 3001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVANZA MDS NORDION 510(k) NO: K060870(TRADITIONAL)
ATTN: ROSS KACHANIWSKY PHONE NO : 613 592 3400 447 MARCH RD. SE DECISION MADE: 15-MAY-06 OTTAWA, ONTARIO, CANADA K2K1X8 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FINGER AND EAR SENSORS AND NEONATAL-ADULT AND ADULT/PEDIATRIC AD MEASUREMENT SPECIALTIES, INC. 510(k) NO: K061191(SPECIAL)
ATTN: KRISTA OAKES PHONE NO : 972-849-5167 2300 MCDERMOTT ROAD SE DECISION MADE: 22-MAY-06 # 200-207 510(k) SUMMARY AVAILABLE FROM FDA PLANO, TX 75025 DEVICE: SWING MEDELA AG 510(k) NO: K053052(TRADITIONAL)
ATTN: WEMER FREI PHONE NO : +41 417 695151 LAETTICHSTRASSE 4B SE DECISION MADE: 02-MAY-06 BAAR, ZUG, SWITZERLAND CH-6341 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SYNVITRO CUMULASE (HYALURONIDASE MEDIUM) MEDICULT A/S 510(k) NO: K060699(TRADITIONAL)
ATTN: RONALD G LEONARDI PHONE NO : 858-586-0751 9915 CAM. CHIRIMOLLA SE DECISION MADE: 10-MAY-06 SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONOACE PICO DIAGNOSTIC ULTRASOUND SYSTEM MEDISON CO., LTD. 510(k) NO: K061213(TRADITIONAL)
ATTN: SHIM KYUNG-AM PHONE NO : 82 2 21941381 1003, DAECHI-DONG SE DECISION MADE: 16-MAY-06 GANGNAM-GU 510(k) SUMMARY AVAILABLE FROM FDA SEOUL, REPUBLIC OF KOREA 135-280 THIRD PARTY REVIEW DEVICE: CONTACT LENS OPHTHALMODYNAMOMETER MEDITRON, GMBH 510(k) NO: K052674(TRADITIONAL)
ATTN: ROBERT N CLARK PHONE NO : 303-234-9412 13605 W. 7TH AVE. SE DECISION MADE: 24-MAY-06 GOLDEN, CO 80401-4604 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO MEDRAD CONTINUUM MR INFUSION SYSTEM MEDRAD, INC. 510(k) NO: K061128(SPECIAL)
ATTN: JOHN M KISTE PHONE NO : 412-767-2400 ONE MEDRAD DR. SE DECISION MADE: 22-MAY-06 INDIANOLA, PA 15051 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDTOX OCYCODONE MEDTOX DIAGNOSTICS, INC. 510(k) NO: K060351(TRADITIONAL)
ATTN: PHILLIP HARTZOG PHONE NO : 336-226-6311 1238 ANTHONY RD. SE DECISION MADE: 12-MAY-06 BURLINGTON, NC 27215 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENTURE ANTERIOR CERVICAL PLATE SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K061274(SPECIAL)
ATTN: RICHARD TREHAME PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 25-MAY-06 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R MEDTRONIC, INC. 510(k) NO: K061127(SPECIAL)
ATTN: PHIL NEURURER PHONE NO : 763-514-2875 8299 CENTRAL AVENUE N.E. SE DECISION MADE: 23-MAY-06 MINNEAPOLIS, MN 55432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS MERITS HEALTH PRODUCTS CO., LTD. 510(k) NO: K053230(TRADITIONAL)
ATTN: STEVE CHAO PHONE NO : 886 423 694986X240 9, ROAD 36 SE DECISION MADE: 16-MAY-06 TAICHUNG INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA TAICHUNG, CHINA (TAIWAN) 407 DEVICE: SONICATOR 730, MODEL ME 730 METTLER ELECTRONICS CORP. 510(k) NO: K053546(ABBREVIATED)
ATTN: ROBERT E FLEMING PHONE NO : 714-533-2221 1333 SOUTH CLAUDINA ST. SE DECISION MADE: 04-MAY-06 ANAHEIM, CA 92805 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDIOIMMUNE XL CARDIAC MARKER CONTROL MICROGENICS CORP. 510(k) NO: K061196(TRADITIONAL)
ATTN: SCOTT HUNTSMAN PHONE NO : 510-979-5169 46360 FREMONT BLVD. SE DECISION MADE: 30-MAY-06 FREMONT, CA 94538 510(k) STATEMENT DEVICE: MICROTEK MEDICAL WARMING DRAPE MICROTEK MEDICAL, INC. 510(k) NO: K060200(TRADITIONAL)
ATTN: THOMAS BONNER PHONE NO : 662-327-1863 512 LEHMBERG RD. SE DECISION MADE: 31-MAY-06 COLUMBUS, MS 39702 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICRUS COURIER MICROCATHETERS MICRUS ENDOVASCULAR CORPORATION 510(k) NO: K060116(TRADITIONAL)
ATTN: MARGARET WEBBER PHONE NO : 408-433-1408 821 FOX LANE SE DECISION MADE: 12-MAY-06 SAN JOSE, CA 95131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MIDIVIEW SERIES OF MICROENDOSCOPES MILLENNIUM DEVICES, INC. 510(k) NO: K051073(TRADITIONAL)
ATTN: JOSEPH LIBRIZZI PHONE NO : 631-582-8440 250 GIBBS RD. SE DECISION MADE: 17-MAY-06 ISLANDIA, NY 11749-2697 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MIM 4.0 (NEURO MIMVISTA CORP. 510(k) NO: K060816(TRADITIONAL)
ATTN: PETER SIMMELINK PHONE NO : 216-896-9798 25200 CHAGRIN BLVD. SUITE 200 SE DECISION MADE: 16-MAY-06 CLEVELAND, OH 44122 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MORTARA SURVEYOR TELEMETRY CENTRAL STATION MORTARA INSTRUMENT, INC. 510(k) NO: K060135(ABBREVIATED)
ATTN: HARLAN L VAN MATRE PHONE NO : 414-354-1600 7865 NORTH 86TH ST. SE DECISION MADE: 15-MAY-06 MILWAUKEE, WI 53224-3431 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORAMAGIC PLUS ORAL WOUND RINSE MPM MEDICAL, INC. 510(k) NO: K060340(TRADITIONAL)
ATTN: RICHARD A HAMER PHONE NO : 248-808-3612 897 CHANCERY CT SE DECISION MADE: 10-MAY-06 MONROE, MI 48161 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SLEEP SPLINT NAKAGAWA DENTAL CLINIC 510(k) NO: K060122(TRADITIONAL)
ATTN: MAKI SAKURABA PHONE NO : 516-742-6705 225 FIRST STREET SE DECISION MADE: 19-MAY-06 MINEOLA, NY 11501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRABECTOME HIGH FREQUENCY GENERATOR/LP NEOMEDIX CORP. 510(k) NO: K061258(TRADITIONAL)
ATTN: THOMAS SCHROEDER PHONE NO : 714-290-5720 15042 PARKWAY LOOP SE DECISION MADE: 18-MAY-06 SUITE A 510(k) SUMMARY AVAILABLE FROM FDA TUSTIN, CA 92780 THIRD PARTY REVIEW DEVICE: MODIFICATION TO SUPEROPEN 0.35T, MODEL NSM-P035 NEUSOFT MEDICAL SYSTEMS CO., LTD. 510(k) NO: K061132(SPECIAL)
ATTN: TIAN YANFANG PHONE NO : 86 24 83660649 NO.3-11, WENHUA ROAD SE DECISION MADE: 24-MAY-06 HEPING DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA SHENYANG, LIAONING, CHINA 110004 DEVICE: TTC PLATE NEWDEAL S.A. 510(k) NO: K060473(TRADITIONAL)
ATTN: JUDITH E O'GRADY PHONE NO : 609-936-2311 311 ENTERPRISE DRIVE SE DECISION MADE: 17-MAY-06 PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LAPIDUS PLATE NEWDEAL S.A. 510(k) NO: K060476(TRADITIONAL)
ATTN: JUDITH E O'GRADY PHONE NO : 609-936-2311 311 ENTERPRISE DRIVE SE DECISION MADE: 17-MAY-06 PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEXA CARPO METACARPAL IMPLANT NEXA ORTHOPEDICS, INC. 510(k) NO: K060386(TRADITIONAL)
ATTN: LOUISE M FOCHT PHONE NO : 858-866-0660 10675 SORRENTO VALLEY ROAD SE DECISION MADE: 10-MAY-06 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92121 DEVICE: CARDIOFAX CE, MODEL ECG-1500 A NIHON KOHDEN AMERICA, INC. 510(k) NO: K052511(TRADITIONAL)
ATTN: SERRAH NAMINI PHONE NO : 949-580-1555 90 ICON ST. SE DECISION MADE: 24-MAY-06 FOOTHILL RANCH, CA 92610-1601 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NODECREST TRANSCRANICAL DOPPLER ULTRASOUND SYSTEM NODECREST LLC 510(k) NO: K060112(TRADITIONAL)
ATTN: E. J SMITH PHONE NO : 410-451-0639 1676 VILLAGE GREEN, SUITE A SE DECISION MADE: 05-MAY-06 CORFTON, MD 21114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 7000 SERIES LIGHTWEIGHT WHEELCHAIR, MODELS 7160L, 7180L AND 7200 NOVA ORTHO-MED, INC. 510(k) NO: K061273(TRADITIONAL)
ATTN: SUE CHEN PHONE NO : 310-352-3600 345 WEST VICTORIA ST. SE DECISION MADE: 23-MAY-06 GARDENA, CA 90248 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: NOVABONE PUTTY - BIOACTIVE SYNTHETIC GRAFT NOVABONE PRODUCTS, LLC 510(k) NO: K060728(TRADITIONAL)
ATTN: DAVID M GAISSER PHONE NO : 386-462-7660 13709 PROGRESS BLVD., #33 SE DECISION MADE: 01-MAY-06 ALACHUA, FL 32615 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPY INTRAOPERATIVE IMAGING SYSTEM NOVADAQ TECHNOLOGIES, INC. 510(k) NO: K060867(TRADITIONAL)
ATTN: ALLISON MANNERS PHONE NO : 905 629 3822 X 240 2585 SKYMARK AVENUE, STE. 306 SE DECISION MADE: 03-MAY-06 MISSISSAUGA, ONTARIO, CANADA L4W 4510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LAPARO-THORACO VIDEOSCOPE XLTF-VAW OLYMPUS AMERICA, INC. 510(k) NO: K053382(TRADITIONAL)
ATTN: TRACY GULSEN PHONE NO : 631-844-5529 PO BOX 9058 SE DECISION MADE: 26-MAY-06 MELVILLE, NY 11747-9058 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OMRON COMPRESSOR SYSTEMS, MODELS NE-C28,NE-C30 OMRON HEALTHCARE, INC. 510(k) NO: K060811(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 317-335-3780 6329 W. WATERVIEW CT. SE DECISION MADE: 25-MAY-06 MCCORDSVILLE, IN 46055-9501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MUCHECK V7.0 ONCOLOGY DATA SYSTEMS, INC. 510(k) NO: K061152(TRADITIONAL)
ATTN: GREG MILLER PHONE NO : 405-680-5222 1601 SW 89TH STREET SE DECISION MADE: 10-MAY-06 BUILDING E-100 510(k) SUMMARY AVAILABLE FROM FDA OKLAHOMA CITY, OK 73159 THIRD PARTY REVIEW DEVICE: PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS ONSET MEDICAL CORPORATION 510(k) NO: K061009(SPECIAL)
ATTN: ALBERT REGO PHONE NO : 949-770-8710 27001 LA PAZ SUITE 312 SE DECISION MADE: 02-MAY-06 MISSION VIEJO, CA 92691 510(k) STATEMENT DEVICE: OPTYSE OPHTHALMOSCOPE OPHTHALMOS LTD. 510(k) NO: K061278(ABBREVIATED)
ATTN: LAURA J GARCIA PHONE NO : 440 179 9532777 UNIT 1 ABBEY BARNS SE DECISION MADE: 16-MAY-06 DUXFORD ROAD 510(k) SUMMARY AVAILABLE FROM FDA ICKLETON, CAMBRIDGE, UNITED KINGDOTHIRD PARTY REVIEW DEVICE: CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE ORIDION CAPNOGRAPHY, INC. 510(k) NO: K060065(TRADITIONAL)
ATTN: SANFORD BROWN PHONE NO : 972 2 5899115 HAR HOTZVIM SCI BASED IND PK SE DECISION MADE: 04-MAY-06 POB 45025 510(k) SUMMARY AVAILABLE FROM FDA JERUSALEM, ISRAEL 91450 DEVICE: SENSOR WALK OTTO BOCK HEALTH CARE, LP 510(k) NO: K052771(TRADITIONAL)
ATTN: BILL CLOVER PHONE NO : 763-489-5142 2 CARLSON PWY. STE. 100 SE DECISION MADE: 03-MAY-06 MINNEAPOLIS, MN 55447-4467 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OXLIFE FREEDOM FIVE OXYGEN CONCENTRATORS, MODEL KXF5 OXLIFE LLC 510(k) NO: K060922(SPECIAL)
ATTN: MARGARET K POTEAT PHONE NO : 828-684-7353 141 TWIN SPRINGS RD. SE DECISION MADE: 30-MAY-06 HENDERSONVILLE, NC 28792 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIGMA ALPHA VAPORIZER PENLON LIMITED 510(k) NO: K060331(TRADITIONAL)
ATTN: BARRY PEARCE PHONE NO : 001 441 235547000 25 BARKER CLOSE SE DECISION MADE: 10-MAY-06 FISHBOURNE, CHICHESTER 510(k) SUMMARY AVAILABLE FROM FDA WEST SUSSEX, UNITED KINGDOM PO18 8BJ DEVICE: EG-3670URK PENTAX MEDICAL COMPANY 510(k) NO: K061068(TRADITIONAL)
ATTN: PAUL SILVA PHONE NO : 800-431-5880 102 CHESTNUT RIDGE RD. SE DECISION MADE: 03-MAY-06 MONTVALE, NJ 07645-1856 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CEMENT-IT ALL PURPOSE, MODEL N97 PENTRON CLINICAL TECHNOLOGIES 510(k) NO: K060698(TRADITIONAL)
ATTN: GREG MOREAU PHONE NO : 203-265-7397 68-70 NORTH PLAINS INDUSTRIAL SE DECISION MADE: 10-MAY-06 ROAD 510(k) SUMMARY AVAILABLE FROM FDA WALLINGFORD, CT 06492 DEVICE: THE PHILIPS INTELLIVUE PATIENT MONITORS, MODELS MP20,MP30,MP40,M PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K061052(SPECIAL)
ATTN: HAUKE SCHIK PHONE NO : 497 031 4632031 HEWLETT-PACKARD-STR. 2 SE DECISION MADE: 26-MAY-06 BOEBLINGEN, GERMANY D-71034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QLAB QUANTIFICATION SOFTWARE PHILIPS ULTRASOUND, INC. 510(k) NO: K061396(TRADITIONAL)
ATTN: LYNN HARMER PHONE NO : 425-487-7312 22100 BOTHELL EVERETT HWY. SE DECISION MADE: 30-MAY-06 P.O. BOX 3003 510(k) SUMMARY AVAILABLE FROM FDA BOTHELL, WA 98041 THIRD PARTY REVIEW DEVICE: CATHASSIST PHYSICIAN TECHNOLOGIES, INC. 510(k) NO: K052952(TRADITIONAL)
ATTN: RANDALL MAY PHONE NO : 714-612-1870 4932 EAST HOLBROOK STREET SE DECISION MADE: 14-MAY-06 ANAHEIM, CA 92807-1154 510(k) STATEMENT DEVICE: PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONS PLAYTEX PRODUCTS, INC. 510(k) NO: K060981(SPECIAL)
ATTN: KEITH EDGETT PHONE NO : 302-678-6880 75 COMMERCE DR. SE DECISION MADE: 09-MAY-06 ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRYOCHECK CLOT APCR PRECISION BIOLOGIC INC. 510(k) NO: K060284(TRADITIONAL)
ATTN: STEPHEN L DUFF PHONE NO : 902 468 6422 X224 900 WINDMILL RD., SUITE 100 SE DECISION MADE: 10-MAY-06 DARTMOUTH, N.S., CANADA B3B 1P7 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTOMOBILE LIGHTER POWER CORD PULMONETIC SYSTEMS, INC. 510(k) NO: K060549(TRADITIONAL)
ATTN: ROBERT C SAMEC PHONE NO : 762-398-8305 117400 MEDINA RD. SE DECISION MADE: 04-MAY-06 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA MINNEAPOLIS, MN 55447-1341 DEVICE: LTV 1200 VENTILATOR PULMONETIC SYSTEMS, INC. 510(k) NO: K060647(TRADITIONAL)
ATTN: ROBERT SAMEC PHONE NO : 763-398-8305 17400 MEDINA ROAD SE DECISION MADE: 25-MAY-06 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA MINNEAPOLIS, MN 55447 DEVICE: PSL PORTABLE SLIT LAMP REICHERT, INC. 510(k) NO: K061330(ABBREVIATED)
ATTN: SANDRA BROWN PHONE NO : 716-686-4599 3374 WALDEN AVE. SE DECISION MADE: 25-MAY-06 DEPEW, NY 14043 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: REMA SHAVER BLADES REMA MEDIZINTECHNIK GMBH. 510(k) NO: K060172(TRADITIONAL)
ATTN: GERALD GOIGITZER PHONE NO : 954-217-8780 731-733 SHOTGUN ROAD SE DECISION MADE: 31-MAY-06 FT. LAUDERDALE, FL 33326 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALLIENT SORBET HEMODIALYSIS SYSTEM, MODEL 1100 RENAL SOLUTIONS, INC. 510(k) NO: K060381(SPECIAL)
ATTN: DAVID J VANELLA PHONE NO : 724-772-6900 770 COMMONWEALTH DR. SE DECISION MADE: 24-MAY-06 WARRENDALE, PA 15086 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3.0T PEDIATRIC HEAD AND SPINE ARRAY, MODEL 808GE3000 RESONANCE INNOVATIONS LLC 510(k) NO: K061170(SPECIAL)
ATTN: RANDALL JONES PHONE NO : 402-934-2650 12530 HARNEY CIRCLE SE DECISION MADE: 25-MAY-06 OMAHA, NE 68154 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RHYTHMLINK DISC ELECTRODES RHYTHMLINK INTERNATIONAL, LLC 510(k) NO: K061148(TRADITIONAL)
ATTN: JAMES W MEWBORNE PHONE NO : 803-252-1222 1256 FIRST ST. SOUTH EXTENSION SE DECISION MADE: 10-MAY-06 COLUMBIA, SC 29209 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: RS-1000 ZOOM SLITLAMP WITH OPTION RIGHTMEDICAL PRODUCTS, LLC 510(k) NO: K060869(TRADITIONAL)
ATTN: HARUMI KUMAHARA PHONE NO : 757-963-7064 200 EXPRESSWAY COURT SE DECISION MADE: 11-MAY-06 VIRGINIA BEACH, VA 23462 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH ROCHE DIAGNOSTICS CORP. 510(k) NO: K060585(TRADITIONAL)
ATTN: RANDY JOHNSON PHONE NO : 317-521-3532 9115 HAGUE RD. SE DECISION MADE: 03-MAY-06 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENZYME IMMUNOASSAY, VANCOMYCIN ROCHE DIAGNOSTICS CORP. 510(k) NO: K060586(TRADITIONAL)
ATTN: DIMITRIS DEMIRTZOGLOU PHONE NO : 317-521-7688 9115 HAGUE RD. SE DECISION MADE: 11-MAY-06 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRECISET DAT PLUS I, PRECISET DAT PLUS II AND CFAS DAT QUALITATI ROCHE DIAGNOSTICS CORP. 510(k) NO: K060645(ABBREVIATED)
ATTN: DIMITRIS DEMIRTZOGLOU PHONE NO : 317-521-7688 9115 HAGUE RD. SE DECISION MADE: 30-MAY-06 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM ROCHE DIAGNOSTICS CORP. 510(k) NO: K061048(SPECIAL)
ATTN: CORINA HARPER PHONE NO : 317-521-3831 9115 HAGUE RD. SE DECISION MADE: 17-MAY-06 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PIEZOTOME SATELEC 510(k) NO: K060274(TRADITIONAL)
ATTN: STEVE SALESKY PHONE NO : 856-222-9888 130 GAITHER DRIVE SE DECISION MADE: 01-MAY-06 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA MT. LAUREL, NJ 08054 DEVICE: PIEZOTOME SATELEC 510(k) NO: K060275(TRADITIONAL)
ATTN: STEVE SALESKY PHONE NO : 856-222-9988 130 GAITHER DRIVE SE DECISION MADE: 03-MAY-06 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA MT. LAUREL, NJ 08054 DEVICE: SAUFLON NEW DAY (METHAFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSA SAUFLON PHARMACEUTICALS, LTD. 510(k) NO: K052832(TRADITIONAL)
ATTN: TANYA FAIR PHONE NO : +44 208 3224231 49-53 YORK ST. SE DECISION MADE: 15-MAY-06 TWICKENHAM, MIDDLESEX, UNITED KING510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARGUS, MODEL LCM SCHILLER AG 510(k) NO: K053207(TRADITIONAL)
ATTN: MARKUS BUETLER PHONE NO : 417 664 252 ALTGASSE 68 SE DECISION MADE: 19-MAY-06 BAAR, ZG, SWITZERLAND 6341 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIO 1-KIT BIOSORB FILLED CARTRIDGE SCIENCE FOR BIOMATERIALS 510(k) NO: K061022(TRADITIONAL)
ATTN: DENIS CLEMENT PHONE NO : 335 624 22101 ZI DU MONGE SE DECISION MADE: 24-MAY-06 LOURDES, FRANCE 65100 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BREATH ALCOHOL TEST SYSTEM, MODEL AL-6000 SENTECH KOREA CORP. 510(k) NO: K060343(TRADITIONAL)
ATTN: MATTHEW H SON PHONE NO : 201-943-9411 21 GRAND AVE. SUITE 103 SE DECISION MADE: 11-MAY-06 PALISADES PARK, NJ 07650 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TEXTURED POWDER FREE NITRILE EXAM GLOVES (BLACK COLOR), CHEMO LA SHEN WEI (USA), INC. 510(k) NO: K060073(TRADITIONAL)
ATTN: CYNTHIA LIU PHONE NO : 510-429-8692 33278 CENTRAL AVE., SE DECISION MADE: 01-MAY-06 SUITE 102 510(k) STATEMENT UNION CITY, CA 94587 DEVICE: PM-8000 EXPRESS PATIENT MONITOR, MODEL PM-8000 EXPRESS SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K053193(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN - FALK PHONE NO : 480-451-7502 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 18-MAY-06 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PM-9000 EXPRESS PATIENT MONITOR SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K053234(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 04-MAY-06 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DP-6600 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K060949(SPECIAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 04-MAY-06 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AXIOM ARISTOS FX PLUS SIEMENS MEDICAL SOLUTIONS USA INC.510(k) NO: K061054(SPECIAL)
ATTN: GARY JOHNSON PHONE NO : 601-448-1778 51 VALLEY STREAM PARKWAY SE DECISION MADE: 09-MAY-06 E-50 510(k) SUMMARY AVAILABLE FROM FDA MALVERN, PA 19355 DEVICE: COHERENCE ONCOLOGIST WORKSPACE, MODEL 2.0 AND PHYSICIST WORKSPAC SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K060633(TRADITIONAL)
ATTN: CHRISTINE DUNBAR PHONE NO : 925-602-8139 4040 NELSON AVE. SE DECISION MADE: 01-MAY-06 CONCORD, CA 94520 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OR HEAD COIL 1.5 T SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K060758(TRADITIONAL)
ATTN: JUDITH CAMPBELL PHONE NO : 610-448-4918 51 VALLEY STREAM PKWY. SE DECISION MADE: 05-MAY-06 MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SINCLAIR ORAL RINSE SINCLAIR PHARMACEUTICALS LIMITED 510(k) NO: K053166(TRADITIONAL)
ATTN: MICHAEL KILLEEN PHONE NO : 972 478 4380 BOROUGH ROAD SE DECISION MADE: 17-MAY-06 GODALMING, SURREY, UNITED KINGDOM 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SLEEPNET MOJO FULL FACE MASK -SMALL, MODEL NO. 53835, MEDIUM ,MO SLEEPNET CORP. 510(k) NO: K060273(TRADITIONAL)
ATTN: PAUL CHIESA PHONE NO : 603-624-1911 1050 PERIMETER RD. SE DECISION MADE: 02-MAY-06 MANCHESTER AIR CENTER 510(k) SUMMARY AVAILABLE FROM FDA MANCHESTER, NH 03103 DEVICE: POWDER FREE NITRILE EXAMINATION GLOVE (BLACK AND GRAY) SMART GLOVE CORP. SDN BHD 510(k) NO: K060724(TRADITIONAL)
ATTN: CHO SOW FONG PHONE NO : 603 329 16100 BATU 5 3/4, JALAN KAPAR SE DECISION MADE: 17-MAY-06 KLANG 510(k) STATEMENT SELANGOR DARUL ESHAN, MALAYSIA 42100 DEVICE: POWDER FREE NITRILE EXAMINATION GLOVE COATED WITH CUCUMBER WITH SMART GLOVE CORP. SDN BHD 510(k) NO: K060726(TRADITIONAL)
ATTN: CHO SOW FONG PHONE NO : 603 329 16100 BATU 5 3/4, JALAN KAPAR SE DECISION MADE: 25-MAY-06 KLANG 510(k) STATEMENT SELANGOR DARUL ESHAN, MALAYSIA 42100 DEVICE: LEGION COBALT CHROME REVISION KNEE SYSTEM SMITH & NEPHEW, INC. 510(k) NO: K060742(SPECIAL)
ATTN: JASON SELLS PHONE NO : 901-399-5520 1450 BROOKS RD. SE DECISION MADE: 03-MAY-06 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REFLECTION 3 ACETABULAR SYSTEM SMITH & NEPHEW, INC. 510(k) NO: K061253(SPECIAL)
ATTN: KATIE LOGEROT PHONE NO : 901-399-5778 1450 BROOKS RD. SE DECISION MADE: 31-MAY-06 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PORT-A-CATH, PORT-A-CATH II, PROPORT AND P.A.S. PORT IMPLANTABLE SMITHS MEDICAL MD, INC. 510(k) NO: K060036(TRADITIONAL)
ATTN: MELANIE HESS PHONE NO : 651-628-7333 1265 GREY FOX RD. SE DECISION MADE: 17-MAY-06 ST. PAUL, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLARIS I310D INTRAORAL CAMERA SYSTEM & ACCESSORIES SOTA PRECISION OPTICS, INC. 510(k) NO: K061175(SPECIAL)
ATTN: JAY MANSOUR PHONE NO : 678-908-8180 845 ARONSON LAKE COURT SE DECISION MADE: 23-MAY-06 ROSWELL, GA 30075 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPECIALEYES 50 AND SPECIALEYES 49 SHPERE AND TORIC SOFT CONTACT SPECIALEYES LLC 510(k) NO: K060821(TRADITIONAL)
ATTN: ARTHUR WARD PHONE NO : 813-645-2855 962 ALLEGRO LANE SE DECISION MADE: 18-MAY-06 APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 15.5FR DECATHLON COATED TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER SPIRE BIOMEDICAL, INC. 510(k) NO: K060155(TRADITIONAL)
ATTN: DONALD FICKETT PHONE NO : 781-275-6001 ONE PATRIOTS PARK SE DECISION MADE: 09-MAY-06 BEDFORD, MA 01730-2396 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODE STEREOTAXIS, INC. 510(k) NO: K051760(TRADITIONAL)
ATTN: PETER A TAKES PHONE NO : 314-615-6940 4041 FOREST PARK AVE. SE DECISION MADE: 05-MAY-06 ST. LOUIS, MO 63108 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: REPROCESSED ENDOSCOPIC TROCAR STERILMED, INC. 510(k) NO: K052299(TRADITIONAL)
ATTN: THOMAS A DOLD PHONE NO : 763-488-3410 11400 73RD AVE. NORTH, #100 SE DECISION MADE: 23-MAY-06 MAPLE GROVE, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED BALOON INFLATION DEVICE STERILMED, INC. 510(k) NO: K053188(TRADITIONAL)
ATTN: BRUCE R LESTER PHONE NO : 888-856-4870 11400 73RD AVE. NORTH, #100 SE DECISION MADE: 04-MAY-06 MAPLE GROVE, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HIPSTAR FEMORAL STEM STRYKER ORTHOPAEDICS 510(k) NO: K051223(TRADITIONAL)
ATTN: TIFFANI ROGERS PHONE NO : 201-831-5412 325 CORPORATE DRIVE SE DECISION MADE: 10-MAY-06 MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRYKER SPINE VLIFT VERTEBRAL BODY REPLACEMENT SYSTEM STRYKER SPINE 510(k) NO: K060506(TRADITIONAL)
ATTN: SIMONA VOIC PHONE NO : 201-760-8145 2 PEARL COURT SE DECISION MADE: 25-MAY-06 ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XIA TITANIUM AND 4.5 SPINAL SYSTEMS STRYKER SPINE 510(k) NO: K060979(SPECIAL)
ATTN: SIMONA VOIC PHONE NO : 201-760-8145 2 PEARL COURT SE DECISION MADE: 19-MAY-06 ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURETEK REPROCESSED LAPAROSCOPIC INSTRUMENTS SURETEK MEDICAL 510(k) NO: K052690(TRADITIONAL)
ATTN: MIKE SAMMON PHONE NO : 864-281-9302 44 BELLWOOD FARMS SE DECISION MADE: 12-MAY-06 GREENVILLE, SC 29607 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURETEK MEDICAL REPROCESSED COMPRESSION SLEEVES SURETEK MEDICAL 510(k) NO: K052691(TRADITIONAL)
ATTN: MIKE SAMMON PHONE NO : 864-281-9302 44 BELLWOOD FARMS SE DECISION MADE: 17-MAY-06 GREENVILLE, SC 29607 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURETEK MEDICAL REPROCESSED ELECTROSURGICAL ELECTRODES SURETEK MEDICAL 510(k) NO: K052692(TRADITIONAL)
ATTN: MIKE SAMMON PHONE NO : 864-281-9302 44 BELLWOOD FARMS SE DECISION MADE: 10-MAY-06 GREENVILLE, SC 29607 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURETEK MEDICAL REPROCESSED ARTHROSCOPIC BLADES AND BURS SURETEK MEDICAL 510(k) NO: K052695(TRADITIONAL)
ATTN: MIKE SAMMON PHONE NO : 864-281-9302 44 BELLWOOD FARMS SE DECISION MADE: 10-MAY-06 GREENVILLE, SC 29607 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLUE COLOUR POWDER FREE BARRIERPRO POLYMER BP2000 POLYBUTADIENE SYNTEX HEALTHCARE PRODUCTS CO. LTD510(k) NO: K061192(TRADITIONAL)
ATTN: KATHY LIU PHONE NO : 909-591-7888 3973 SCHAFER AVE. SE DECISION MADE: 23-MAY-06 CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYSMEX AUTOMATED HEMATOLOGY ANALYZER MODELS XS SERIES SYSMEX AMERICA, INC. 510(k) NO: K060656(TRADITIONAL)
ATTN: NINA GAMPERLING PHONE NO : 847-996-4675 ONE NELSON C. WHITE PARKWAY SE DECISION MADE: 10-MAY-06 MUNDELEIN, IL 60060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPACER-S TEMPORARY SHOULDER SPACER TECRES SPA 510(k) NO: K060535(TRADITIONAL)
ATTN: DIANE TAYLOR PHONE NO : 352-377-1140 2320 N.W. 66TH COURT SE DECISION MADE: 24-MAY-06 GAINSVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COSMATRIX TEI BIOSCIENCES INC. 510(k) NO: K060829(ABBREVIATED)
ATTN: KENNETH JAMES PHONE NO : 617-268-1616 7 ELKINS ST. SE DECISION MADE: 17-MAY-06 BOSTON, MA 02127 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XENFORM SOFT TISSUE REPAIR MATRIX TEI BIOSCIENCES INC. 510(k) NO: K060984(SPECIAL)
ATTN: KENNETH JAMES PHONE NO : 617-268-1616 7 ELKINS ST. SE DECISION MADE: 17-MAY-06 BOSTON, MA 02127 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TISSUEMEND SOFT TISSUE REPAIR MATRIX TEI BIOSCIENCES INC. 510(k) NO: K060989(SPECIAL)
ATTN: KENNETH JAMES PHONE NO : 617-268-1616 7 ELKINS ST. SE DECISION MADE: 15-MAY-06 BOSTON, MA 02127 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTRODUCER ASSEMBLY WITH ROTATOR LOCK TELEFLEX MEDICAL 510(k) NO: K060519(SPECIAL)
ATTN: LORI HAYS PHONE NO : 847-572-8027 2345 WAUKEGAN ROAD SE DECISION MADE: 05-MAY-06 SUITE 140 510(k) SUMMARY AVAILABLE FROM FDA BANNOCKBURN, IL 60015 DEVICE: DEKNA-LOK MODEL BP1000V2L TELEFLEX MEDICAL 510(k) NO: K060801(TRADITIONAL)
ATTN: KIMBERLY EDGERTON PHONE NO : 919-361-3957 2917 WECK DRIVE SE DECISION MADE: 17-MAY-06 RESEARCH TRIANGLE PARK, NC 27709 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AQUARIUSAPS SERVER TERARECON, INC. 510(k) NO: K061214(TRADITIONAL)
ATTN: EMILLY TOJIMA PHONE NO : 650-653-4313 2955 CAMPUS DR., SUITE 325 SE DECISION MADE: 15-MAY-06 SAN MATEO, CA 94403 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: BABYBEAT CORDLESS THE NEWMAN GROUP, LLC 510(k) NO: K061091(TRADITIONAL)
ATTN: SPENCER NEWMAN PHONE NO : 312-455-9808 935 WEST CHESTNUT ST. SE DECISION MADE: 04-MAY-06 SUITE 430 510(k) STATEMENT CHICAGO, IL 60622 THIRD PARTY REVIEW DEVICE: VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100 THERALIGHT, INC. 510(k) NO: K061295(SPECIAL)
ATTN: KEVIN E DALY PHONE NO : 760-930-8000 2794 LOKER AVE. WEST,SUITE 105 SE DECISION MADE: 25-MAY-06 CARLSBAD, CA 92010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IF TRUE SINE INTERFERENTIAL STIMULATOR / MODEL WL-2206A1 & WI-22 THERATECH, INC. 510(k) NO: K060975(SPECIAL)
ATTN: MICHAEL PRICE PHONE NO : 615-865-4000 1109 MYATT BLVD. SE DECISION MADE: 10-MAY-06 MADISON, TN 37115 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TINNITUS PHASE-OUT TINNITUS CONTROL, INC. 510(k) NO: K061111(SPECIAL)
ATTN: RUSS PAGANO PHONE NO : 202-546-1262 719 A STREET, NE SE DECISION MADE: 16-MAY-06 WASHINGTON, DC 20002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REFA, PHYSIOLOGICAL AMPLIFIER TMS INTERNATIONAL BV 510(k) NO: K060374(ABBREVIATED)
ATTN: DAVID W WAGNER PHONE NO : 303-674-3070 7744 SWAPS TRAIL SE DECISION MADE: 30-MAY-06 EVERGREEN, CO 80439 510(k) STATEMENT DEVICE: TSX-201A, AQUILION LB CT SCANNER WITH RESPIRATORY GATING TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K061187(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000 2441 MICHELLE DR. SE DECISION MADE: 12-MAY-06 P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA TUSTIN, CA 92781-2068 THIRD PARTY REVIEW DEVICE: 15-INCH (38CM) COLOR LCD MONITOR CDL1566A TOTOKU ELECTRIC CO., LTD 510(k) NO: K060961(TRADITIONAL)
ATTN: MIKIO HASEGAWA PHONE NO : 812 683 45469 300 OYA SE DECISION MADE: 01-MAY-06 UEDA, NAGANO, JAPAN 386-0192 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUSCEPTIBILITY TEST PLATE FOR VANCOMYCIN VRSA LIMITATION REMOVAL TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K060783(TRADITIONAL)
ATTN: CYNTHIA C KNAPP PHONE NO : 800-871-8909 982 KEYNOTE CIRCLE SUITE 6 SE DECISION MADE: 16-MAY-06 CLEVELAND, OH 44131 510(k) STATEMENT DEVICE: GENIUS 2 INFRARED TYMPANIC ELECTRONIC THERMOMETER, MODEL 303000 TYCO HEALTHCARE GROUP, LP 510(k) NO: K060649(TRADITIONAL)
ATTN: KEITH MARTIN PHONE NO : 508-261-8440 15 HAMPSHIRE ST. SE DECISION MADE: 22-MAY-06 MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEARBLUE EASY DIGITAL PREGNANCY TEST UNIPATH LTD. 510(k) NO: K060128(TRADITIONAL)
ATTN: LOUISE ROBERTS PHONE NO : 44 123 4835564 PRIORY BUSINESS PARK SE DECISION MADE: 25-MAY-06 BEDFORD, UNITED KINGDOM MK44 3UP 510(k) STATEMENT DEVICE: DSNARE DIMINUTIVE POLYPECTOMY AND SUCTION SYSTEM, MODEL 00711087 UNITED STATES ENDOSCOPY GROUP, INC510(k) NO: K061201(SPECIAL)
ATTN: MICHAEL WOLF PHONE NO : 440-639-4494 5976 HEISELY RD. SE DECISION MADE: 30-MAY-06 MENTOR, OH 44060 510(k) STATEMENT DEVICE: AUTO SUTUR ENDO GIA STAPLERS UNITED STATES SURGICAL, A DIVISION510(k) NO: K061095(TRADITIONAL)
ATTN: FRANK GIANELLI PHONE NO : 203-492-5352 150 GLOVER AVE. SE DECISION MADE: 31-MAY-06 NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: USGI TRANSPORT ENDOSCOPIC GUIDE USGI MEDICAL 510(k) NO: K061216(SPECIAL)
ATTN: MARY LOU MOONEY PHONE NO : 949-369-3890 1140 CALLE CORDILLERA SE DECISION MADE: 15-MAY-06 SAN CLEMENTE, CA 92673 510(k) STATEMENT DEVICE: HEMOHALT HEMOSTASIS PAD VANSON-HALOSOURCE, INC. 510(k) NO: K060409(TRADITIONAL)
ATTN: ERIC ROBINSON PHONE NO : 425-974-1989 14716 NE 87TH ST. SE DECISION MADE: 17-MAY-06 REDMOND, WA 98052 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRILOGY RADIOTHERAPY DELIVERY SYSTEM VARIAN MEDICAL SYSTEMS 510(k) NO: K061140(TRADITIONAL)
ATTN: VY TRAN PHONE NO : 650-424-5731 3100 HANSEN WAY SE DECISION MADE: 15-MAY-06 PALO ALTO, CA 94304-1129 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IG4 IMAGE GUIDED SYSTEM VERAN MEDICAL TECHNOLOGIES, INC. 510(k) NO: K060903(TRADITIONAL)
ATTN: TORSTEN M LYON PHONE NO : 303-594-3666 2409 21ST AVENUE SOUTH SE DECISION MADE: 11-MAY-06 SUITE 205 510(k) SUMMARY AVAILABLE FROM FDA NASHVILLE, TN 37212 DEVICE: VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11) VISION BIOSYSTEMS INC. 510(k) NO: K060227(ABBREVIATED)
ATTN: RON LAGERQUIST PHONE NO : 800-753-7264 700 LONGWATER DRIVE SE DECISION MADE: 25-MAY-06 NORWELL, MA 02061 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OMI RETRACTABLE SAFETY SYRINGE VITALCARE GROUP, INC. 510(k) NO: K060109(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727 P.O. BOX 7007 SE DECISION MADE: 05-MAY-06 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO REBILDA DC VOCO GMBH 510(k) NO: K060893(SPECIAL)
ATTN: MICHAEL SUS PHONE NO : 490 472 1719214 ANTON-FLETTNER-STRASSE 1-3 SE DECISION MADE: 25-MAY-06 CUXHAVEN, GERMANY D-27472 510(k) STATEMENT DEVICE: BIFIX QM VOCO GMBH 510(k) NO: K060894(SPECIAL)
ATTN: MICHAEL SUS PHONE NO : 490 472 1719214 ANTON-FLETTNER-STRASSE 1-3 SE DECISION MADE: 02-MAY-06 CUXHAVEN, GERMANY D-27472 510(k) STATEMENT DEVICE: DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEM W & H DENTALWERK BUERMOOS GMBH 510(k) NO: K060287(TRADITIONAL)
ATTN: GABRIELE WIENBECK PHONE NO : 011 436 2746236397 IGNAZ GLASER STR. 53 SE DECISION MADE: 03-MAY-06 BUERMOOS, AUSTRIA A-5111 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 40 L HIGH FLOW INSUFFLATOR F113 W.O.M. WORLD OF MEDICINE AG 510(k) NO: K060723(TRADITIONAL)
ATTN: SUSANNE RAAB PHONE NO : 202-390-8227 1490 CAMBRIDGE STREET SE DECISION MADE: 25-MAY-06 CAMBRIDGE, MA 02139 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES WEI FANG JIUZHOU GLOVES CO., LTD. 510(k) NO: K060884(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441 209 BEI SI HUAN ZHONG RD., SE DECISION MADE: 04-MAY-06 R. 106 BLDG. 1 JIANXIANG YUAN 510(k) SUMMARY AVAILABLE FROM FDA BEIJING, HAIDIAN DISTRIC, CHINA DEVICE: POWDERED VINYL PATIENT EXAMINATION GLOVES WEI FANG JIUZHOU GLOVES CO., LTD. 510(k) NO: K060886(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441 209 BEI SI HUAN ZHONG RD., SE DECISION MADE: 04-MAY-06 R. 106 BLDG. 1 JIANXIANG YUAN 510(k) SUMMARY AVAILABLE FROM FDA BEIJING, HAIDIAN DISTRIC, CHINA DEVICE: KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND ACCES WFR/AQUAPLAST CORP. 510(k) NO: K060671(TRADITIONAL)
ATTN: J. DAMON KIRK PHONE NO : 201-891-1042 30 LAWLINS PARK SE DECISION MADE: 04-MAY-06 WYCKOFF, NJ 07481 510(k) STATEMENT DEVICE: PROFEMUR TL HIP STEM WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K060358(SPECIAL)
ATTN: MATT PAUL PHONE NO : 901-867-4350 5677 AIRLINE RD. SE DECISION MADE: 10-MAY-06 ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIMMER DENTAL ONE PIECE TAPERED ABUTMENT, MODELS TAC1, TACW1, TA ZIMMER DENTAL INC. 510(k) NO: K060880(SPECIAL)
ATTN: WILLIAM FISHER PHONE NO : 760-929-4166 1900 ASTON AVE. SE DECISION MADE: 17-MAY-06 CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRABECULAR METAL ACETABULAR AUGMENTS ZIMMER TRABECULAR 510(k) NO: K061067(TRADITIONAL)
ATTN: ROBERT A POGGIE PHONE NO : 201-818-1800 80 COMMERCE DR. SE DECISION MADE: 25-MAY-06 ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIMMER M/L TAPER HIP PROSTHESIS ZIMMER, INC. 510(k) NO: K060040(SPECIAL)
ATTN: KAREN CAIN PHONE NO : 574-372-4219 P.O. BOX 708 SE DECISION MADE: 12-MAY-06 WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, SIZES 8MM AND 1 ZIMMER, INC. 510(k) NO: K060704(SPECIAL)
ATTN: DALENE T BINKLEY PHONE NO : 574-372-4907 P.O. BOX 708 SE DECISION MADE: 19-MAY-06 WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEXGEN COMPLETE KNEE SOLUTION ULTRACONGRUENT (UC-FLEX) FIXED BEA ZIMMER, INC. 510(k) NO: K060722(TRADITIONAL)
ATTN: BRANDON HIPSHER PHONE NO : 574-371-8083 P.O. BOX 708 SE DECISION MADE: 26-MAY-06 WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 298 TOTAL WITH SUMMARIES 257 TOTAL WITH STATEMENTS 41
Updated June 5, 2006
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