SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE) 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD 01-MAR-2008 THROUGH 31-MAR-2008 DEVICE: MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R MEDTRONIC INC. 510(k) NO: K073324(TRADITIONAL)
ATTN: BECKY HANNACK PHONE NO : 763-514-2875 8299 CENTRAL AVENUE NE SE DECISION MADE: 13-MAR-08 MINNEAPOLIS, MN 55432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HAPPYNEB II, HAPPYNEB III, SPEEDY, NEBBY PLUS AND MYNEB, MODEL 5 3A HEALTH CARE S.R.L. 510(k) NO: K072163(TRADITIONAL)
ATTN: MAUREEN O'CONNELL PHONE NO : 978-207-1245 5 TIMBER LANE SE DECISION MADE: 06-MAR-08 NORTH READING, MA 01864 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PECD-01 AND PECD QUICK-01 3M ESPE AG DENTAL PRODUCTS 510(k) NO: K080514(SPECIAL)
ATTN: DESI W SOEGIARTO PHONE NO : 011 498 1527001169 ESPE PLATZ SE DECISION MADE: 26-MAR-08 SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MOUNTABLE ENDOSCOPIC BLADE A.M. SURGICAL, INC. 510(k) NO: K080133(TRADITIONAL)
ATTN: VINCENT PASCALE PHONE NO : 631-979-9777 290 EAST MAIN ST. SUITE 200 SE DECISION MADE: 13-MAR-08 SMITHTOWN, NY 11787 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AAP BONE PLATES AND SCREW IMPLANTS AAP IMPLANTATE AG 510(k) NO: K072411(TRADITIONAL)
ATTN: MARC SEEGERS PHONE NO : 493 075 019192 LORENZWEG 5 SE DECISION MADE: 20-MAR-08 BERLIN, GERMANY 12099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AAP CANNULATED SCREW AND DARCO HEADED SCREW AAP IMPLANTATE AG 510(k) NO: K080101(SPECIAL)
ATTN: MARC SEEGERS PHONE NO : 49 30 75019192 LORENZWEG 5 SE DECISION MADE: 25-MAR-08 BERLIN, GERMANY 12099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACTIVATED ASPARTATE AMINOTRANSFERASE ABBOT LABORATORIES 510(k) NO: K071525(TRADITIONAL)
ATTN: LINDA MORRIS PHONE NO : 972-518-6711 1920 HURD DRIVE SE DECISION MADE: 19-MAR-08 IRVING, TX 75038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: FOX PLUS PTA CATHETER ABBOTT VASCULAR-VASCULAR SOLUTIONS510(k) NO: K080264(SPECIAL)
ATTN: IVALEE COHEN PHONE NO : 408-845-0682 3200 LAKESIDE DR. SE DECISION MADE: 26-MAR-08 SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SINUS SPACER ACCLARENT, INC. 510(k) NO: K072891(TRADITIONAL)
ATTN: KERI YEN PHONE NO : 650-687-5874 1525-B O'BRIEN DR. SE DECISION MADE: 19-MAR-08 MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER ACCLARENT, INC. 510(k) NO: K073041(TRADITIONAL)
ATTN: KERI YEN PHONE NO : 650-687-5874 1525-B O'BRIEN DR. SE DECISION MADE: 11-MAR-08 MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IONTOPHORESIS SYSTEM ACCLARENT, INC. 510(k) NO: K073276(TRADITIONAL)
ATTN: KERI YEN PHONE NO : 650-687-5874 1525-B O'BRIEN DR. SE DECISION MADE: 05-MAR-08 MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACE SURGICAL SECURE-MINI IMPLANT SYSTEM, MODEL 09-270X-XX ACE SURGICAL SUPPLY CO., INC. 510(k) NO: K073343(TRADITIONAL)
ATTN: J. EDWARD CARCHIDI PHONE NO : 508-588-3100 1034 PEARL ST. SE DECISION MADE: 13-MAR-08 BROCKTON, MA 02301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS ACUMEN MEDICAL, INC. 510(k) NO: K080500(SPECIAL)
ATTN: KEVIN MACDONALD PHONE NO : 408-530-1810 275 SANTA ANA COURT SE DECISION MADE: 13-MAR-08 SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AEMED STIMPAD ACU-TENS TRANSCUTANEOUS ELECTRICAL NERVE STIMULATO AEMED, INC. 510(k) NO: K071120(TRADITIONAL)
ATTN: RALPH JUGO PHONE NO : 305-409-7791 6530 SW 49TH TERRACE SE DECISION MADE: 13-MAR-08 SOUTH MIAMI, FL 33155 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIOX MINO AEROCRINE AB 510(k) NO: K072816(TRADITIONAL)
ATTN: JOEL SLOMOFF PHONE NO : 202-662-4688 801 PENNSYLVANIA AVE. SE DECISION MADE: 03-MAR-08 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SLIMMANAGER BODY COMPOSITION ANALYZER, MODELS N40 AND SM-300 AIIA COMMUNICATION INC. 510(k) NO: K073227(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854 P.O. BOX 7007 SE DECISION MADE: 20-MAR-08 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AIRISTAR AIR PURIFICATION SYSTEM, MODEL 500 & 1000 AIRISTAR TECHNOLOGIES, LLC 510(k) NO: K072185(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854 PO BOX 7007 SE DECISION MADE: 27-MAR-08 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ALICIA MENSTRUAL CUP ALICIA INTERNATIONAL PTY LTD. 510(k) NO: K070965(TRADITIONAL)
ATTN: TOM STONE PHONE NO : 61 7 55407372 P.O. BOX 1471 SE DECISION MADE: 05-MAR-08 OXENFORD, QUEENSLAND, AUSTRALIA 42510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PORTABLE VENTILATOR, MODEL EPV-100 ALLIED HEALTHCARE PRODUCTS, INC. 510(k) NO: K072214(TRADITIONAL)
ATTN: WAYNE KARCHER PHONE NO : 314-771-2400 1720 SUBLETTE AVE. SE DECISION MADE: 06-MAR-08 ST. LOUIS, MO 63110 510(k) STATEMENT DEVICE: ALMA LASER NIR MODULE ALMA LASERS LTD. 510(k) NO: K080318(TRADITIONAL)
ATTN: TATIANA EPSTEIN PHONE NO : 011 972 46275357 HALAMISH ST. POB 3021 SE DECISION MADE: 07-MAR-08 INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA CAESAREA, ISRAEL 38900 DEVICE: CAMLOG IMPLANT SYSTEM ABUTMENTS ALTATEC GMBH 510(k) NO: K073553(TRADITIONAL)
ATTN: LINDA K SCHULZ PHONE NO : 858-792-1235 11234 EL CAMINO REAL SE DECISION MADE: 05-MAR-08 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92130 DEVICE: DBEST ONE STEP OCCULT BLOOD TEST KITS AMERITEK USA, INC. 510(k) NO: K071242(TRADITIONAL)
ATTN: K.C. YEE PHONE NO : 425-379-2580 125 130TH ST. SE SE DECISION MADE: 06-MAR-08 EVERETT, WA 98208 510(k) STATEMENT DEVICE: AMICAS VISION SERIES PACS, MODEL 5.5 AMICAS, INC. 510(k) NO: K073526(TRADITIONAL)
ATTN: PATRICE J.C. NEDELEC PHONE NO : 617-779-7858 20 GUEST ST. SE DECISION MADE: 12-MAR-08 BOSTON, MA 02135 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFESTYLES LUBRICATED POLYISOPRENE LATEX MALE CONDOM ANSELL HEALTHCARE PRODUCTS LLC 510(k) NO: K070800(ABBREVIATED)
ATTN: LON D MCILVAIN PHONE NO : 334-794-4231 1635 INDUSTRIAL RD. SE DECISION MADE: 06-MAR-08 DOTHAN, AL 36303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APIERON INSIGHT EXHALED NITRIC OXIDE (ENO) SYSTEM APIERON, INC. 510(k) NO: K073265(TRADITIONAL)
ATTN: RICHARD LOTTI PHONE NO : 650-454-8127 155 JEFFERSON DRIVE SE DECISION MADE: 14-MAR-08 MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMT INITIAL PLACEMENT GI KIT (E2418) AND AMT DILATOR SET (E2419) APPLIED MEDICAL TECHNOLOGY, INC. 510(k) NO: K073034(TRADITIONAL)
ATTN: BRIAN BAKER PHONE NO : 216-475-5577 15653 NEO PKWY. SE DECISION MADE: 14-MAR-08 CLEVELAND, OH 44128 510(k) STATEMENT DEVICE: ARTHROCARE IRRIGATION PUMP, MODEL SIP001-00, SIP001-01 ARTHROCARE CORP. 510(k) NO: K080482(SPECIAL)
ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-736-0224 680 VAQUEROS AVE. SE DECISION MADE: 20-MAR-08 SUNNYVALE, CA 94085-3523 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHROCARE ORTHOWAND SURGICAL DEVICE ARTHROCARE CORP. 510(k) NO: K080610(SPECIAL) ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-736-0224 680 VAQUEROS AVE. SE DECISION MADE: 31-MAR-08 SUNNYVALE, CA 94085-3523 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATRICURE COOLRAIL LINEAR PEN ATRICURE, INC. 510(k) NO: K073605(TRADITIONAL)
ATTN: ALISON GRIMALDI PHONE NO : 513-644-4228 6033 SCHUMACHER PARK DR. SE DECISION MADE: 11-MAR-08 WEST CHESTER, OH 45069 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTR AXIS-SHIELD DIAGNOSTICS, LTD. 510(k) NO: K072686(TRADITIONAL)
ATTN: CLAIRE DORA PHONE NO : 441 382 82000 THE TECHNOLOGY PARK SE DECISION MADE: 17-MAR-08 DUNDEE, SCOTLAND, UNITED KINGDOM D510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DUAL CHAMBER TPN CONTAINER B. BRAUN MEDICAL, INC. 510(k) NO: K073538(TRADITIONAL)
ATTN: TRACY MADDOCK PHONE NO : 610-596-2240 901 MARCON BLVD. SE DECISION MADE: 12-MAR-08 ALLENTOWN, PA 18109-9341 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERILS SINGLE-USE I/A HANDPIECES BAUSCH & LOMB, INC. 510(k) NO: K073023(SPECIAL)
ATTN: NED LUCE PHONE NO : 585-338-6612 1400 NORTH GOODMAN ST. SE DECISION MADE: 12-MAR-08 ROCHESTER, NY 14609 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BAXANO ULTRA LOW PROFILE RONGEUR BAXANO, INC. 510(k) NO: K080494(SPECIAL)
ATTN: SHARON ROCKWELL PHONE NO : 714-695-9269 5582 CHALON ROAD SE DECISION MADE: 04-MAR-08 YORBA LINDA, CA 92886 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCESS ESTRADIOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, BECKMAN COULTER, INC. 510(k) NO: K080166(SPECIAL)
ATTN: JEFFREY L KOLL PHONE NO : 952-368-7899 1000 LAKE HAZELTINE DR. SE DECISION MADE: 19-MAR-08 CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DAPTOMYCIN (0.0313-16 U BECTON, DICKINSON & CO. 510(k) NO: K073589(TRADITIONAL)
ATTN: MONICA GIGUERE PHONE NO : 410-316-4287 7 LOVETON CIR. SE DECISION MADE: 05-MAR-08 SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BELLA BEEKLEY CORP. 510(k) NO: K073262(TRADITIONAL)
ATTN: MARTINE M BOUTTE PHONE NO : 800-233-5539 150 DOLPHIN RD. SE DECISION MADE: 26-MAR-08 BRISTOL, CT 06011 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLUE LATEX EXAM GLOVES NON STERILE CHLORINATED POWDER FREE BETELCARE SDN BHD 510(k) NO: K073299(TRADITIONAL)
ATTN: KENG BENG SIAH PHONE NO : 603 329 03301 LOT 3342, JALAN KERETAPI LAMA SE DECISION MADE: 05-MAR-08 7 1/2 MI OFF JALAN KAPAR 510(k) SUMMARY AVAILABLE FROM FDA SELANGOR, DARUL EHSAN, MALAYSIA 42200 DEVICE: SLENDERTONE ENERVIVE, MODEL 561 BIO-MEDICAL REASEARCH LTD. 510(k) NO: K071666(TRADITIONAL)
ATTN: ANNE-MARIE KEENAN PHONE NO : 353 91 7743000 PARKMORE BUSINESS PARK WEST SE DECISION MADE: 12-MAR-08 GALWAY, IRELAND 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RADIO BIOAQUACARE BIOARTIFICIAL GEL TECHNOLOGIES (BA510(k) NO: K080471(TRADITIONAL)
ATTN: JONATHAN KAHAN PHONE NO : 202-637-5794 555 THIRTEENTH STREET, NW SE DECISION MADE: 05-MAR-08 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRA BIOKIT S.A. 510(k) NO: K072036(TRADITIONAL)
ATTN: JOAN GUIXER PHONE NO : 34 938 6090 CAN MALE S/N SE DECISION MADE: 19-MAR-08 LLICA D'AMUNT 510(k) SUMMARY AVAILABLE FROM FDA BARCELONA, SPAIN 08186 DEVICE: CERTAIN CONTOURED MARGIN CERAMIC ABUTMENT BIOMET 3I, INC. 510(k) NO: K073345(TRADITIONAL)
ATTN: PRISCILLA CARO PHONE NO : 561-776-6785 4555 RIVERSIDE DR. SE DECISION MADE: 07-MAR-08 PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PARALLEL-SIDED EXTENSIVELY COATED FEMORAL STEMS BIOMET MANUFACTURING CORP. 510(k) NO: K073637(TRADITIONAL)
ATTN: ELIZABETH WRAY PHONE NO : 574-267-6639 56 EAST BELL DRIVE PO BX 587 SE DECISION MADE: 20-MAR-08 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VANGUARD KNEE SYSTEM TITANIUM FEMORAL COMPONENTS BIOMET, INC. 510(k) NO: K080204(TRADITIONAL)
ATTN: GARY BAKER PHONE NO : 574-267-6639 56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 20-MAR-08 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOFLEX BIOSPINE CO., LTD. 510(k) NO: K072321(TRADITIONAL)
ATTN: JUSTIN EGGLETON PHONE NO : 202-552-5800 1331 H STREET NW, 12TH FLOOR SE DECISION MADE: 25-MAR-08 WASHINGTON, DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCOUTPRO 8F, 7F AND SLITTER TOOL ADVANCED BIOTRONIK, INC. 510(k) NO: K072329(SPECIAL)
ATTN: JON BRUMBAUGH PHONE NO : 888-345-0374 6024 JEAN ROAD SE DECISION MADE: 25-MAR-08 LAKE OSWEGO, OR 97035 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLACKSTONE ASCENT POSTERIOR OCCIPITAL CERVICO-THORACIC (POCT) SY BLACKSTONE MEDICAL, INC. 510(k) NO: K080394(SPECIAL)
ATTN: WHITNEY G TORNING PHONE NO : 973-406-2838 1211 HAMBURG TURNPIKE SE DECISION MADE: 13-MAR-08 SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA WAYNE, NJ 07470 DEVICE: BLACKSTONE SFS PARALLEL ROD CONNECTORS BLACKSTONE MEDICAL, INC. 510(k) NO: K080407(SPECIAL)
ATTN: WHITNEY G TORNING PHONE NO : 973-406-2838 1211 HAMBURG TURNPIKE SE DECISION MADE: 13-MAR-08 SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA WAYNE, NJ 07470 DEVICE: BLUE SKY BIO DENTAL IMPLANT SYSTEM BLUE SKY BIO, LLC 510(k) NO: K073713(TRADITIONAL)
ATTN: MICHELE VOVOLKA PHONE NO : 847-548-8499 888 E BELVIDERE RD. SE DECISION MADE: 28-MAR-08 SUITE 212 510(k) SUMMARY AVAILABLE FROM FDA GRAYSLAKE, IL 60030 DEVICE: CONVOY ADVANCED DELIVERY SHEATH BOSTON SCIENTIFIC CORP. 510(k) NO: K072719(TRADITIONAL)
ATTN: CINDY MORROW PHONE NO : 408-895-3931 2710 ORCHARD PARKWAY SE DECISION MADE: 07-MAR-08 SAN JOSE, CA 95134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATLANTIS 018 PERIPHERAL IMAGING CATHETER BOSTON SCIENTIFIC CORP. 510(k) NO: K073623(TRADITIONAL)
ATTN: EMILLY TOJIMA PHONE NO : 510-624-2546 47900 BAYSIDE PARKWAY SE DECISION MADE: 13-MAR-08 FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATLANTIS PVIMAGING CATHETER, MODEL H749364560 BOSTON SCIENTIFIC CORP. 510(k) NO: K080272(TRADITIONAL)
ATTN: JANICE BROWN PHONE NO : 510-624-2582 47900 BAYSIDE PARKWAY SE DECISION MADE: 11-MAR-08 FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: B R A H M S PCT SENSITIVE KRYPTOR TEST SYSTEM BRAHMS AKTIENGESELLSCHAFT 510(k) NO: K070310(TRADITIONAL)
ATTN: JONAS LEICHTNER PHONE NO : 410-897-9960 2568A RIVA ROAD SE DECISION MADE: 31-MAR-08 SUITE 207 510(k) SUMMARY AVAILABLE FROM FDA ANNAPOLIS, MD 21401 DEVICE: AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE (IHVLP) C.R. BARD, INC. 510(k) NO: K080170(SPECIAL)
ATTN: SKIP RIMER PHONE NO : 770-784-6160 8195 INDUSTRIAL BLVD. SE DECISION MADE: 25-MAR-08 COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUITY UNIVERSAL CUTTER CARDIAC PACEMAKERS, INC. 510(k) NO: K080154(SPECIAL)
ATTN: KATHLEEN VITTUM PHONE NO : 651-582-4820 4100 HAMLINE AVE., NORTH SE DECISION MADE: 20-MAR-08 ST. PAUL, MN 55112-5798 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RX DC X-RAY UNIT CEFLA S.C.R.L. 510(k) NO: K080076(TRADITIONAL)
ATTN: CLAUDE BERTOIN PHONE NO : 800-323-2690 110 E GRANADA BLVD. SE DECISION MADE: 14-MAR-08 SUITE 207 510(k) STATEMENT ORMOND BEACH, FL 32176 DEVICE: SYSTEM PLUS CONTINENTAL DENTAL LABORATORY 510(k) NO: K073475(TRADITIONAL)
ATTN: KAREEN CHAMBERLAIN PHONE NO : 310-618-8821 1873 WESTERN WAY SE DECISION MADE: 10-MAR-08 TORRANCE, CA 90501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMADEUS ADAPTIVE COMPRESSION THERAPY CONVATEC 510(k) NO: K071763(TRADITIONAL)
ATTN: MARILYN KONICKY PHONE NO : 908-904-2541 200 HEADQUARTERS PARK DR. SE DECISION MADE: 07-MAR-08 SKILLMAN, NJ 08558 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGISIS BIODESIGN TISSUE GRAFT COOK BIOTECH, INC. 510(k) NO: K073391(TRADITIONAL)
ATTN: MARY A FADERAN PHONE NO : 765-497-3355 1425 INNOVATION PLACE SE DECISION MADE: 21-MAR-08 WEST LAFAYETTE, IN 47906 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLEXOR EVAC ASPIRATION CATHETER COOK, INC. 510(k) NO: K073627(TRADITIONAL)
ATTN: KAREN BRADBURN PHONE NO : 812-339-2235 750 DANIELS WAY PO BX 489 SE DECISION MADE: 04-MAR-08 BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IVS TUNNELLER DEVICES COVIDIEN UK MANUFACTURING LTD 510(k) NO: K073164(TRADITIONAL)
ATTN: SHARON ALEXANDER PHONE NO : 203-492-6060 60 MIDDLETOWN AVENUE SE DECISION MADE: 05-MAR-08 NORTH HAVEN, CT 06473 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IPULSE, MODEL I400 CYDEN LIMITED 510(k) NO: K080406(SPECIAL)
ATTN: MICHEAL KIERNAN PHONE NO : 441 792 485682 TECHNIUM, KINGS ROAD SE DECISION MADE: 10-MAR-08 THE DOCKS 510(k) SUMMARY AVAILABLE FROM FDA SWANSEA, WALES, UNITED KINGDOM SA1 8PH DEVICE: DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L DADE BEHRING, INC. 510(k) NO: K073604(TRADITIONAL)
ATTN: YUK-TING LEWIS PHONE NO : 302-631-7626 500 GBC DR, MAILSTOP 514 SE DECISION MADE: 13-MAR-08 NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COOPDECH ENDOBRONCHIAL BLOCKER TUBE, MODELS BBT-A30XXX, BBT-B30X DAIKEN MEDICAL CO, LTD. 510(k) NO: K071694(TRADITIONAL)
ATTN: FUMIAK KANAI PHONE NO : 81 3 38188577 4-2-1 YUSHIMA, BUNKYO-KU SE DECISION MADE: 20-MAR-08 TOKYO, JAPAN 113-0034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DANYANG HUALI K7 WHEELCHAIR DANYANG HUAYI MEDICAL SUPPLY & EQU510(k) NO: K080207(TRADITIONAL)
ATTN: NORMAN F ESTRIN PHONE NO : 301-279-2899 9109 COPENHAVER DRIVE SE DECISION MADE: 12-MAR-08 POTOMAC, MD 20854 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FRIALIT PLUS, XIVE S PLUS, XIVE TG PLUS, ANKYLOS PLUS, DENTAL IM DENTSPLY INTERNATIONAL, INC. 510(k) NO: K073075(TRADITIONAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511 SUSQUEHANNA COMMERCE CTR., 221 SE DECISION MADE: 31-MAR-08 W. PHILADELPHIA ST., SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA YORK, PA 17404 DEVICE: MTA ROOT CANAL SEALER DENTSPLY INTERNTIONAL 510(k) NO: K080203(TRADITIONAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511 221 W. PHILADELPHIA ST. STE.60 SE DECISION MADE: 26-MAR-08 SUSQUEHANNA COMMERCE CRT. WEST 510(k) SUMMARY AVAILABLE FROM FDA YORK, PA 17404 DEVICE: FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTS DENTSPLY INTL. 510(k) NO: K072730(TRADITIONAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511 221 WEST PHILADELPHIA STREET SE DECISION MADE: 27-MAR-08 SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA YORK, PA 17404 DEVICE: MICRO QA+ ANCHOR WITHT #3-0 ORTHOCORD SUTURE, MODEL 212843, MICR DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K080352(SPECIAL)
ATTN: KRISTINE CHRISTO PHONE NO : 508-977-3359 325 PARAMOUNT DR. SE DECISION MADE: 12-MAR-08 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIISA LEVER INTEGRATED INTERVENTIONAL SYSTEM ADAPTER, MODEL VSL- DEVICE PARTNERS INTERNATIONAL 510(k) NO: K073260(ABBREVIATED)
ATTN: MONICA E DOUGHERTY PHONE NO : 210-957-2083 4305 ENTERPRISE DRIVE SE DECISION MADE: 13-MAR-08 SUITE E 510(k) SUMMARY AVAILABLE FROM FDA WINSTON-SALEM, NC 27106 DEVICE: PRODIGY VOICE BLOOD GLUCOSE MONITORING SYSTEM DIAGNOSTIC DEVICES INC. 510(k) NO: K073118(TRADITIONAL)
ATTN: ERICA LI PHONE NO : 886 2 86358080 4F, 88, SEC. 1, KWANG FU ROAD SE DECISION MADE: 05-MAR-08 SAN CHUNG, TAIPEI, CHINA (TAIWAN) 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MOD DIAZYME LABORATORIES 510(k) NO: K073488(TRADITIONAL)
ATTN: CHARLES YU PHONE NO : 858-455-4761 12889 GREGG COURT SE DECISION MADE: 07-MAR-08 POWAY, CA 92064 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DRAEGER ALCOTEST 6510 DRAGER SAFETY 510(k) NO: K063443(TRADITIONAL)
ATTN: EVE DAMIANO PHONE NO : 610-597-5499 333 ALPINE STREET SE DECISION MADE: 11-MAR-08 EMMAUS, PA 18049 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SLEEP QUALITY DYNADX CORPORATION 510(k) NO: K070855(TRADITIONAL)
ATTN: EJ SMITH PHONE NO : 410-451-0639 1676 VILLAGE GREEN STE. A SE DECISION MADE: 20-MAR-08 CROFTON, MD 21114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LI EDAN INSTRUMENTS, INC. 510(k) NO: K080087(TRADITIONAL)
ATTN: WILLIAM STERN PHONE NO : 914-376-5200 1 ODELL PLAZA SE DECISION MADE: 11-MAR-08 YONKERS, NY 10701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 5 MEGAPIXEL MONOCHROME LCD MONITOR, MODEL RADIFORCE GS520 EIZO NANAO CORPORATION 510(k) NO: K080422(SPECIAL)
ATTN: HIROAKI HASHIMOTO PHONE NO : 81 76 2742468 153 SHIMOKASHIWANO-CHO SE DECISION MADE: 10-MAR-08 HAKUSAN, ISHIKAWA-KEN, JAPAN 924-8510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COLOR LCD MONITOR, MODEL RADIFORCE RX211 EIZO NANAO CORPORATION 510(k) NO: K080457(SPECIAL)
ATTN: HIROAKI HASHIMOTO PHONE NO : 817 627 42468 153 SHIMOKASHIWANO-CHO SE DECISION MADE: 20-MAR-08 HAKUSAN, ISHIKAWA-KEN, JAPAN 924-8510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTEGRE, MODEL LP581 ELLEX MEDICAL PTY. LTD. 510(k) NO: K080423(SPECIAL)
ATTN: KEVIN HOWARD PHONE NO : 61 881 045200 82 GILBERT ST. SE DECISION MADE: 11-MAR-08 ADELAIDE, SOUTH AUSTRALIA, AUSTRAL510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HABIB HEXABLATE 10 EMCISION, LTD. 510(k) NO: K080717(TRADITIONAL)
ATTN: NAGY HABIB PHONE NO : 440 208 3832273 LIVER SURGERY, HAMMERSMITH SE DECISION MADE: 27-MAR-08 HOSPITAL CAMPUS, DU CANE RD. 510(k) SUMMARY AVAILABLE FROM FDA LONDON, UK, UNITED KINGDOM W12 OHSTHIRD PARTY REVIEW DEVICE: TENS/IF 14 EMSI 510(k) NO: K071869(TRADITIONAL)
ATTN: CHERITA JAMES PHONE NO : 703-562-9800 901 KING STREET SE DECISION MADE: 07-MAR-08 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA ALEXANDRIA, VA 22331 DEVICE: ENCORE SHOULDER PRIMARY HUMERAL STEM, MODEL 500-00, ENCORE SHOUL ENCORE MEDICAL, L.P. 510(k) NO: K080402(TRADITIONAL)
ATTN: TEFFANY HUTTO PHONE NO : 512-834-6255 9800 METRIC BLVD. SE DECISION MADE: 28-MAR-08 AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORAC ENDIUS, INC. 510(k) NO: K080258(TRADITIONAL)
ATTN: REGINA WAGNER PHONE NO : 508-643-0983 23 WEST BACON ST. SE DECISION MADE: 10-MAR-08 PLAINVILLE, MA 02762 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO VIEWMATE SYSTEM EP MEDSYSTEMS 510(k) NO: K073709(SPECIAL)
ATTN: LARRY PICCIANO PHONE NO : 856-753-8533 COOPER RUN EXECUTIVE PARK SE DECISION MADE: 11-MAR-08 575 ROUTE 73 N. BLDG. D 510(k) SUMMARY AVAILABLE FROM FDA WEST BERLIN, NJ 08091 DEVICE: ANCHORAGE ACCESS KIT EPITEK, INC. 510(k) NO: K073507(TRADITIONAL)
ATTN: WERNER HAMPL PHONE NO : 952-230-9886 4801 W. 81ST STREET SE DECISION MADE: 05-MAR-08 SUITE 105 510(k) SUMMARY AVAILABLE FROM FDA BLOOMINGTON, MN 55437 DEVICE: ETHICON ENDO SURGERY SHEATH AND ARTICULATING ACCESSORY CHANNEL - ETHICON ENDO-SURGERY, INC. 510(k) NO: K073484(TRADITIONAL)
ATTN: RENEE L ROWE PHONE NO : 513-337-8243 4545 CREEK RD. SE DECISION MADE: 10-MAR-08 CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 5MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL EV3 INC. 510(k) NO: K072301(TRADITIONAL)
ATTN: DAVID WORRELL PHONE NO : 763-398-7344 4600 NATHAN LN. NORTH SE DECISION MADE: 18-MAR-08 PLYMOUTH, MN 55442-2920 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFU FENWAL, INC. 510(k) NO: K073339(TRADITIONAL)
ATTN: TAMMY DAVIS PHONE NO : 847-550-7955 THREE CORPORATE DRIVE SE DECISION MADE: 03-MAR-08 LAKE ZURICH, IL 60047 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RESPIRATORY HUMIDIFIER, MODEL MR850 FISHER & PAYKEL HEALTHCARE, LTD. 510(k) NO: K073706(TRADITIONAL)
ATTN: ADELE BINDON PHONE NO : 649 574 0100 15 MAURICE PAYKEL PLACE SE DECISION MADE: 31-MAR-08 EAST TAMAKI, NEW ZEALAND 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FOTONA FIDELIS III ER:YAG/ND:YAG LASER SYSTEM FAMILY FOTONA D.D. 510(k) NO: K070355(TRADITIONAL)
ATTN: STOJAN TROST PHONE NO : 386 150 09100 STEGNE 7, SE DECISION MADE: 04-MAR-08 LJUBLJANA, SLOVENIA 1210 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JNE IMPLANT SYSTEM GC AMERICA, INC. 510(k) NO: K072425(ABBREVIATED)
ATTN: CARL JENKINS PHONE NO : 847-234-7500 1025 EVERETT ROAD, SUITE 100 SE DECISION MADE: 10-MAR-08 LAKE FOREST, IL 60045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND GE HEALTHCARE 510(k) NO: K061907(TRADITIONAL)
ATTN: JOEL C KENT PHONE NO : 781-449-8685 86 PILGRIM ROAD SE DECISION MADE: 27-MAR-08 NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DASH 2500 PATIENT MONITOR GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K080157(TRADITIONAL)
ATTN: SHARON UNTZ PHONE NO : 414-362-2436 8200 WEST TOWER AVE. SE DECISION MADE: 24-MAR-08 MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OMNI-VUE SYSTEM GENESIS DIGITAL IMAGING, INC. 510(k) NO: K073062(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 940-300-8601 1600 MANCHESTER WAY SE DECISION MADE: 10-MAR-08 CORINTH, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TINNITUS SOUND GENERATOR MODULE GN RESOUND A/S 510(k) NO: K073636(TRADITIONAL)
ATTN: LARS HAGANDER PHONE NO : 454 575 1111 LAUTRUPBJERG 7 SE DECISION MADE: 13-MAR-08 BALLERUP, DENMARK DK-2750 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GRAFTYS BCP GRAFTYS 510(k) NO: K073064(ABBREVIATED)
ATTN: ANTHONY LE NAOUR PHONE NO : 33 442 603000 415 RUE CHARLES NICOLAS LEDOUX SE DECISION MADE: 11-MAR-08 EIFFEL PARK BAT D 510(k) SUMMARY AVAILABLE FROM FDA AIX EN PROVENCE, FRANCE 13854 DEVICE: LED.L, LED.M, LED.G, LED.B GUILIN WOODPECKER MEDICAL INSTRUME510(k) NO: K080025(TRADITIONAL)
ATTN: CHARLIE MACK PHONE NO : 931-937-8093 340 SHADY GROVE ROAD SE DECISION MADE: 19-MAR-08 FLINTVILLE, TN 37335 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: VFLEX POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK, GX CORPORATION SDN BHD 510(k) NO: K080066(TRADITIONAL)
ATTN: FOO KHON PU PHONE NO : 603 329 11600 LOT 6487, BATU 5 3/4, SEMENTA SE DECISION MADE: 05-MAR-08 JALAN KAPAR 510(k) STATEMENT KLANG, SELANGOR, MALAYSIA 42100 DEVICE: HENKE SASS WOLF OF AMERICA ARTHROSCOPE HENKE SASS WOLF OF AMERICA, INC. 510(k) NO: K080560(TRADITIONAL)
ATTN: LYNETTE HOWARD PHONE NO : 908-788-4580 106 EAST 5TH AVENUE SE DECISION MADE: 18-MAR-08 MOUNT DORA, FL 32757 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIM HILL LABORATORIES CO. 510(k) NO: K072256(TRADITIONAL)
ATTN: BRADY ALLER PHONE NO : 610-644-2867 3 N. BACTON HILL RD. SE DECISION MADE: 12-MAR-08 FRAZER, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EVOLUTION BLOOD GLUCOSE MONITORING SYSTEM HMD BIOMEDICAL LLC 510(k) NO: K072369(TRADITIONAL)
ATTN: MERRELL SHYE PHONE NO : 321-225-3620 8855 GRISSOM PARKWAY SE DECISION MADE: 21-MAR-08 TITUSVILLE, FL 32780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APEX 2.0 SOFTWARE FOR QDR X-RAY BONE DENSITOMETERS HOLOGIC, INC. 510(k) NO: K072847(TRADITIONAL)
ATTN: BRYAN COWELL PHONE NO : 781-999-7300 35 CROSBY DR. SE DECISION MADE: 28-MAR-08 BEDFORD, MA 01730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABX PENTRA URINE CAL HORIBA ABX 510(k) NO: K071779(ABBREVIATED)
ATTN: OLIVIER DUCAMP PHONE NO : 334 671 47392 PARC EUROMEDECINE SE DECISION MADE: 05-MAR-08 RUE DU CADUCEE, BP 7290 510(k) SUMMARY AVAILABLE FROM FDA MONTPELLIER, FRANCE 34184 DEVICE: VARIAX DISTAL RADIUS TORX SCREWS HOWMEDICA OSTEONICS CORP. 510(k) NO: K080667(SPECIAL)
ATTN: DANIELLE HILLMAN PHONE NO : 201-831-6365 325 CORPORATE DRIVE SE DECISION MADE: 19-MAR-08 MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREEDOM HYCOR BIOMEDICAL, INC. 510(k) NO: K080322(SPECIAL)
ATTN: P. NARAYAN NAYAK PHONE NO : 714-933-3145 7272 CHAPMAN AVE. SE DECISION MADE: 05-MAR-08 GARDEN GROVE, CA 92841 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISTAL HUMERAL PLATES WITH ANGULAR STABILITY I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTE510(k) NO: K080184(TRADITIONAL)
ATTN: AL LIPPINOCOTT PHONE NO : 952-492-5858 3150 E. 200TH ST. SE DECISION MADE: 26-MAR-08 PRIOR LAKE, MN 55372 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPLUS DENTAL IMPLANTS (HA) IMPLANT DIRECT LLC 510(k) NO: K073161(TRADITIONAL)
ATTN: THOMAS GOTTENBOS PHONE NO : 818-444-3317 27030 MALIBU HILLS RD. SE DECISION MADE: 07-MAR-08 CALABASAS HILLS, CA 91301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUANTA LITE CCP3.1 IGG/IGA ELISA INOVA DIAGNOSTICS, INC. 510(k) NO: K072944(TRADITIONAL)
ATTN: RUFUS BURLINGAME PHONE NO : 858-586-9900 9900 OLD GROVE RD. SE DECISION MADE: 05-MAR-08 SAN DIEGO, CA 92131-1638 510(k) STATEMENT DEVICE: SUB-TALAR LOK, MODEL 7-11 MM INSTRATEK, INC. 510(k) NO: K080280(TRADITIONAL)
ATTN: JEFF SEAVEY PHONE NO : 281-890-8020 210 SPRING HILL DR. SE DECISION MADE: 14-MAR-08 SUITE 130 510(k) SUMMARY AVAILABLE FROM FDA THE WOODLANDS, TX 77386 DEVICE: MODIFICATION TO:INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM INTUITIVE SURGICAL, INC. 510(k) NO: K080155(SPECIAL)
ATTN: MICHAEL H YRAMATEGUI PHONE NO : 408-523-2100 950 KIFER RD. SE DECISION MADE: 06-MAR-08 SUNNYVALE, CA 94086-5206 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENTS AND CONTROL S INTUITIVE SURGICAL, INC. 510(k) NO: K080291(TRADITIONAL)
ATTN: KAREN UYESUGI PHONE NO : 408-523-8918 950 KIFER RD. SE DECISION MADE: 19-MAR-08 SUNNYVALE, CA 94086-5206 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VISTAKON (NARAFILCON) A SOFT CONTACT LENS JOHNSON & JOHNSON VISION CARE, INC510(k) NO: K073485(TRADITIONAL)
ATTN: ROSALIND B WILLIAMS PHONE NO : 904-443-3946 7500 CENTURION PKWY. SE DECISION MADE: 03-MAR-08 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA JACKSONVILLE, FL 32256 DEVICE: CAYMAN BUTTRESS PLATE SYSTEM K2M, INC. 510(k) NO: K080302(TRADITIONAL)
ATTN: RICHARD WOODS PHONE NO : 703-777-3155 751 MILLER DR.,S.E., SUITE F1 SE DECISION MADE: 24-MAR-08 LEESBURG, VA 20175 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUICKCAT EXTRACTION CATHETER, MODEL 60090-01 KENSEY NASH CORP. 510(k) NO: K073519(SPECIAL)
ATTN: CINDY VARUGHESE PHONE NO : 484-713-2100 735 PENNSYLVANIA DRIVE SE DECISION MADE: 28-MAR-08 EXTON, PA 19341 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KFH ENERGY, MODEL: E1 KINGFISHER HEALTHCARE NV 510(k) NO: K073008(TRADITIONAL)
ATTN: NEIL R ARMSTRONG PHONE NO : 011 441 763222505 BUSINESS & TECHNOLOGY CENTER SE DECISION MADE: 11-MAR-08 BESSEMER DRIVE 510(k) SUMMARY AVAILABLE FROM FDA STEVENAGE, UNITED KINGDOM SG1 2DX DEVICE: MODELS TENS 7000, EMS 7500 AND TWIN STIM KOALATY PRODUCTS, INC. 510(k) NO: K080661(TRADITIONAL)
ATTN: JAY MANSOUR PHONE NO : 678-908-8180 845 ARONSON LAKE COURT SE DECISION MADE: 24-MAR-08 ROSWELL, GA 30075 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: NOCC HYDROPHILIC WOUND DRESSING KYTOGENICS, INC 510(k) NO: K080010(TRADITIONAL)
ATTN: MARINA ZAZANIS PHONE NO : 973-410-0200 466 SOUTHERN BLVD. SE DECISION MADE: 14-MAR-08 ADAMS BUILDING, FIRST FLOOR 510(k) SUMMARY AVAILABLE FROM FDA CHATHAM, NJ 07928 DEVICE: LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY LABORIE MEDICAL TECHNOLOGIES, CORP510(k) NO: K073552(TRADITIONAL)
ATTN: BARBARA MORNET PHONE NO : 802-857-1300 400 AVE D, STE 10 SE DECISION MADE: 05-MAR-08 WILLISTON, VT 05495 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MANDREL GUIDEWIRES OR M-WIRE LAKE REGION MEDICAL 510(k) NO: K080508(SPECIAL)
ATTN: KAREN MORTENSEN PHONE NO : 952-448-5111 340 LAKE HAZELTINE DRIVE SE DECISION MADE: 21-MAR-08 CHASKA, MN 55318 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPINAL SPHERE SYSTEM LIFE SPINE 510(k) NO: K073274(TRADITIONAL)
ATTN: REBECCA M BROOKS PHONE NO : 847-884-6117 2401 W. HASSELL RD. SE DECISION MADE: 17-MAR-08 SUITE 1535 510(k) SUMMARY AVAILABLE FROM FDA HOFFMAN ESTATES, IL 60169 DEVICE: LUMINEX LX 100/200 INSTRUMENT LUMINEX CORP. 510(k) NO: K073506(TRADITIONAL)
ATTN: NANCY KRUNIC PHONE NO : 416 593 4323 439 UNIVERSITY AVENUE SUITE SE DECISION MADE: 07-MAR-08 2000 510(k) STATEMENT TORONTO, CANADA M5G 1Y8 DEVICE: K-Y BRAND YOURS+MINE MCNEIL-PPC, INC. 510(k) NO: K072421(TRADITIONAL)
ATTN: NADER FOTOUHI PHONE NO : 908-904-3730 199 GRANDVIEW ROAD SE DECISION MADE: 06-MAR-08 SKILLMAN, NJ 08558 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DRIVE SOLSTICE OXYGEN CONCENTRATOR MEDICAL DEPOT 510(k) NO: K080391(TRADITIONAL)
ATTN: ARTHUR WARD PHONE NO : 813-645-2855 962 ALLEGRO LANE SE DECISION MADE: 18-MAR-08 APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: COMPACT AUTO-SAFETY INJECTOR (CASI) MEDICAL HOUSE (ASI) LIMITED 510(k) NO: K073476(TRADITIONAL)
ATTN: ROSE Y GUANG PHONE NO : 44 114 2619011 199, NEWHALL RD. SE DECISION MADE: 07-MAR-08 SHEFFIELD, UNITED KINGDOM S9 2QJ 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IPUP 200 (INTELLIGENT PRESSURE ULCER PREVENTION) MEDICAL TECHNOLOGY SYSTEMS, INC. 510(k) NO: K063175(TRADITIONAL)
ATTN: ELLIS K NAM PHONE NO : 312-503-0073 6101 N. SHERIDAN RD. SE DECISION MADE: 14-MAR-08 SUITE 40D 510(k) STATEMENT CHICAGO, IL 60660-6828 DEVICE: QPLAQUE MR MEDIS MEDICAL IMAGING SYSTEMS, B.V510(k) NO: K073156(TRADITIONAL)
ATTN: J.I. HOLLANDER PHONE NO : 31 071 5223244 9 SCHUTTERSVELD SE DECISION MADE: 04-MAR-08 P.O. BOX 384 510(k) SUMMARY AVAILABLE FROM FDA LEIDEN, NETHERLANDS 2316 XG DEVICE: MEDLINE SINGLE PATIENT USE BLOOD PRESSURE CUFF MEDLINE INDUSTRIES, INC. 510(k) NO: K071244(TRADITIONAL)
ATTN: MATT CLAUSEN PHONE NO : 847-643-4785 ONE MEDLINE PL. SE DECISION MADE: 05-MAR-08 MUNDELEIN, IL 60060 510(k) STATEMENT DEVICE: MEDLINE GASTROSTOMY TUBE MEDLINE INDUSTRIES, INC. 510(k) NO: K073718(ABBREVIATED)
ATTN: MATT CLAUSEN PHONE NO : 847-643-4785 ONE MEDLINE PL. SE DECISION MADE: 19-MAR-08 MUNDELEIN, IL 60060 510(k) STATEMENT DEVICE: XPS 3000 SYSTEM MEDTRONIC XOMED, INC. 510(k) NO: K073255(TRADITIONAL)
ATTN: DAVID GUZEK PHONE NO : 904-296-9600 6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 24-MAR-08 JACKSONVILLE, FL 32216 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MERRIES K-PHATE BONE GRAFT SUBSTITUTE MERRIES INTERNATIONAL INC. 510(k) NO: K063157(TRADITIONAL)
ATTN: SOPHIA LEE PHONE NO : 886 289 117712 2F 3-1, BAU-HUNG RD. SE DECISION MADE: 10-MAR-08 SHIN-TIEN, TAIPEI, CHINA (TAIWAN) 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE LATEX EXAMINATION GLOVES - 18 MILS AT FINGER, BLUE C METACURE SURGICAL GLOVES SDN BHD 510(k) NO: K072197(TRADITIONAL)
ATTN: AZMAN ISMAIL PHONE NO : 603 778 12829 NO. 1, JLN 203, OFF JALAN SE DECISION MADE: 12-MAR-08 TANDANG 510(k) STATEMENT PETALING JAYA, MALAYSIA 46050 DEVICE: EARPOPPER, MODEL EP-2000, EP-2100, EP-3000 MICROMEDICS, INC. 510(k) NO: K073401(TRADITIONAL)
ATTN: TOM LOPAC PHONE NO : 651-452-1977 1270 EAGAN INDUSTRIAL ROAD SE DECISION MADE: 14-MAR-08 SUITE 120 510(k) SUMMARY AVAILABLE FROM FDA EAGAN, MN 55121 DEVICE: MODIFICATION TO REBOUND HRD MINNESOTA MEDICAL DEVELOPMENT, INC510(k) NO: K080393(SPECIAL)
ATTN: JULIE BULVER PHONE NO : 763-588-9839 4050 OLSON MEMORIAL HIGHWAY SE DECISION MADE: 13-MAR-08 SUITE 350 510(k) SUMMARY AVAILABLE FROM FDA MINNEAPOLIS, MN 55422 DEVICE: LIPOSAT BASIC (INFILTRATION PUMP), MODEL 92-007 688 MOELLER MEDICAL GMBH & CO. KG 510(k) NO: K072793(SPECIAL)
ATTN: BILL KELLEY PHONE NO : 949-292-8477 23832 VIA MONTE SE DECISION MADE: 04-MAR-08 COTO DE CAZA, CA 92679-4001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KANTERON DICOM STATION (KDS), MODEL 3.0 MONICA VEYTIA 510(k) NO: K073176(TRADITIONAL)
ATTN: MONICA VEYTIA PHONE NO : 305-283-1517 7195 SW 101 ST SE DECISION MADE: 19-MAR-08 MIAMI, FL 33156 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LED CURING LIGHT MONITEX INDUSTRIAL CO., LTD. 510(k) NO: K080035(TRADITIONAL)
ATTN: SHU-LUNG WANG PHONE NO : 886 229 993869 6F, 70 SEC. 1 GUANG-FU ROAD SE DECISION MADE: 03-MAR-08 SAN-CHUNG CITY, CHINA (TAIWAN) 241510(k) STATEMENT DEVICE: MINITAPE EXTRA URETHRAL SLING MPATHY MEDICAL DEVICES, LTD. 510(k) NO: K073647(SPECIAL)
ATTN: LOUIS J MAZZARESE PHONE NO : 203-318-8270 24 BARBERRY LANE SE DECISION MADE: 03-MAR-08 MADISON, CT 06443 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MCT-DIABETES MYCARE TEAM, INC. 510(k) NO: K073699(TRADITIONAL)
ATTN: DIANE MANDELL HORWITZ PHONE NO : 703-242-0027 PO BOX 2552 SE DECISION MADE: 26-MAR-08 FAIRFAX, VA 22031 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ND LOW SPEED AIRMOTOR AND HANDPIECE, HIGHSPEED AIRTURBINE HANDP NAKAMURA MAGNIFIER CO., LTD. 510(k) NO: K073652(TRADITIONAL)
ATTN: CHARLIE ITO PHONE NO : 949-474-0176 17972 SKY PARK CIRCLE SE DECISION MADE: 20-MAR-08 SUITE J 510(k) SUMMARY AVAILABLE FROM FDA IRVINE, CA 92614 DEVICE: PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, NDO SURGICAL, INC. 510(k) NO: K073671(TRADITIONAL)
ATTN: JOHN J VOZELLA PHONE NO : 508-337-8881 125 HIGH ST., SE DECISION MADE: 26-MAR-08 SUITE 7 510(k) SUMMARY AVAILABLE FROM FDA MANSFIELD, MA 02048 DEVICE: SAVANNAH LUMBAR PERCUTANEOUS STABILIZATION SYSTEM NEUROSPINE INNOVATIONS AND SOLUTIO510(k) NO: K072116(TRADITIONAL)
ATTN: RICHARD JANSEN PHONE NO : 952-431-5999 13540 GUILD AVE. SE DECISION MADE: 20-MAR-08 APPLE VALLEY, MN 55124 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEUSOFT SPIRAL CT SCANNER SYSTEM, MODEL NEUVIZ VERSION 2.0 NEUSOFT MEDICAL SYSTEMS CO., LTD. 510(k) NO: K080540(TRADITIONAL)
ATTN: TIAN YANFANG PHONE NO : 86 24 83660649 NO.3-11, WENHUA ROAD SE DECISION MADE: 13-MAR-08 HEPING DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA SHENYANG, LIAONING, CHINA 110004 THIRD PARTY REVIEW DEVICE: E-VAC NEW LEAF MEDICAL, INC. 510(k) NO: K073455(SPECIAL)
ATTN: RICHARD T NOCK PHONE NO : 440-748-7000 11476 HAWKE RD SE DECISION MADE: 25-MAR-08 SUITE #C 510(k) STATEMENT COLUMBIA STATION, OH 44028 DEVICE: PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION NIHON KOHDEN AMERICA, INC. 510(k) NO: K073550(SPECIAL)
ATTN: JACK COGGAN PHONE NO : 949-580-1555 90 ICON ST. SE DECISION MADE: 28-MAR-08 FOOTHILL RANCH, CA 92610-1601 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETH NOVAMIN TECHNOLOGY, INC. 510(k) NO: K080228(TRADITIONAL)
ATTN: ROBERT G ROTHFRITZ PHONE NO : 386-418-1551 13859 PROGRESS BLVD.,#600 SE DECISION MADE: 27-MAR-08 ALACHUA, FL 32615 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPAT DUALFLO ENTERAL DELIVERY PUMP SET WITH SPIKERIGHT PIERCIN NOVARTIS NUTRITION CORP. 510(k) NO: K080340(SPECIAL)
ATTN: THOMAS A DOLD PHONE NO : 952-848-6480 12500 WHITEWATER DRIVE SE DECISION MADE: 05-MAR-08 MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPINOUS PROCESS PLATE SYSTEM NUVASIVE, INC. 510(k) NO: K073278(TRADITIONAL)
ATTN: LAETITIA COUSIN PHONE NO : 858-909-1868 4545 TOWNE CENTRE COURT SE DECISION MADE: 28-MAR-08 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DURETTE IMPLANT OCULO PLASTIK, INC. 510(k) NO: K073293(TRADITIONAL)
ATTN: JEAN-FRANCOIS DURETTE PHONE NO : 514 381 3292 200 SAUVE WEST SE DECISION MADE: 19-MAR-08 MONTREAL, QC, CANADA H3L 1Y9 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMALL INTESTINAL VIDEOSCOPE SYSTEM OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K071254(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 484-896-5688 3500 CORPORATE PARKWAY SE DECISION MADE: 25-MAR-08 PO BOX 610 510(k) SUMMARY AVAILABLE FROM FDA CENTER VALLEY, PA 18034-0610 DEVICE: EVIS EXERA II 180 SYSTEM OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K072957(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 484-896-5688 3500 CORPORATE PARKWAY SE DECISION MADE: 18-MAR-08 PO BOX 610 510(k) SUMMARY AVAILABLE FROM FDA CENTER VALLEY, PA 18034-0610 DEVICE: TRAUMACAD VERSION 2.0 ORTHOCRAT, LTD. 510(k) NO: K073714(TRADITIONAL)
ATTN: GEORGE J HATTUB PHONE NO : 508-479-6116 291 HILLSIDE AVENUE SE DECISION MADE: 19-MAR-08 SOMERSET, MA 02726 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODULAR FOOT SYSTEM ORTHOHELIX SURGICAL DESIGNS, INC. 510(k) NO: K073624(TRADITIONAL)
ATTN: DEREK LEWIS PHONE NO : 330-869-9562 1815 W. MARKET ST. SE DECISION MADE: 20-MAR-08 SUITE 205 510(k) SUMMARY AVAILABLE FROM FDA AKRON, OH 44313 DEVICE: DENTAL IMPLANT, DENTAL ABUTMENT, ABUTMENT SCREW, COVER SCREW, HE OSPOL AB 510(k) NO: K070184(TRADITIONAL)
ATTN: LENNART CARLSSON PHONE NO : 46 40 6037610 JORGEN KOCKSGATAN 9 SE DECISION MADE: 24-MAR-08 MALMO, SWEDEN SE-211 20 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: US/SS/GS SYSTEM OSSTEM IMPLANT CO LTD 510(k) NO: K073247(TRADITIONAL)
ATTN: MINJOO KIM PHONE NO : 215-736-2990 ONE BEN FAIRLESS DR SE DECISION MADE: 07-MAR-08 FAIRLESS HILLS, PA 19030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HU II / HS II FIXTURE SYSTEM OSSTEM IMPLANT CO.,LTD 510(k) NO: K080387(SPECIAL)
ATTN: MIN JOO KIM PHONE NO : 215-736-2990 1 BEN FAIRLESS DR. SE DECISION MADE: 07-MAR-08 FAIRLESS, PA 19030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLEXUR M OSTEOTECH, INC. 510(k) NO: K073405(TRADITIONAL)
ATTN: CHRISTOPHER TALBOT PHONE NO : 732-542-2800 51 JAMES WAY SE DECISION MADE: 03-MAR-08 EATONTOWN, NJ 07724 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERMOSTAT 900 ADMINISTRATION SET, MODEL ASH 100, 200 AND 300 PALADIN BIOMEDICAL CORPORATION 510(k) NO: K073363(TRADITIONAL)
ATTN: ROBERT BICKFORD PHONE NO : 781-964-2237 506 BOSTON POST ROAD SE DECISION MADE: 20-MAR-08 WESTON, MA 02493 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO PALOMAR LUX1540 HANDPIECE PALOMAR MEDICAL PRODUCTS, INC. 510(k) NO: K073583(TRADITIONAL)
ATTN: SHARON TIMBERLAKE PHONE NO : 781-993-2414 82 CAMBRIDGE ST. SE DECISION MADE: 26-MAR-08 BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MRJ EXTENDED PARAMED SRL 510(k) NO: K080098(TRADITIONAL)
ATTN: MICHAEL A DOUGLAS PHONE NO : 978-975-7530 39 HIGH STREET SE DECISION MADE: 10-MAR-08 NORTH ANDOVER, MA 01845 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SECURE PARKELL, INC. 510(k) NO: K073698(TRADITIONAL)
ATTN: DANIEL R SCHECHTER PHONE NO : 631-249-1134 300 EXECUTIVE DR. SE DECISION MADE: 19-MAR-08 EDGEWOOD, NY 11717 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JET PORT PLUS HP CATHETER SYSTEM PFM MEDICAL, INC 510(k) NO: K072481(TRADITIONAL)
ATTN: SALVADORE PALOMARES PHONE NO : 760-758-8749 2605 TEMPLE HEIGHTS DRIVE SE DECISION MADE: 07-MAR-08 SUITE A 510(k) SUMMARY AVAILABLE FROM FDA OCEANSIDE, CA 92056 DEVICE: STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0 PHILIPS MEDICAL SYSTEMS 510(k) NO: K080461(SPECIAL)
ATTN: ZETY BILLARD PHONE NO : 978-659-3603 3000 MINUTEMAN RD. SE DECISION MADE: 13-MAR-08 ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURESIGNS VM SERIES PATIENT MONITOR, MODELS VM4, VM6, VM8, VM3 A PHILIPS MEDICAL SYSTEMS 510(k) NO: K080495(SPECIAL)
ATTN: MARY KRUITWAGEN PHONE NO : 978-659-4932 3000 MINUTEMAN RD. SE DECISION MADE: 24-MAR-08 ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HFO SHOULDER COIL PHILIPS MEDICAL SYSTEMS MR FINLAND510(k) NO: K080120(TRADITIONAL)
ATTN: CATHERINE CONNELL PHONE NO : 440-483-5581 595 MINER ROAD SE DECISION MADE: 10-MAR-08 CLEVELAND, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HD7 DIAGNOSTIC ULTRASOUND SYSTEM PHILLIPS MEDICAL SYSTEMS 510(k) NO: K080548(TRADITIONAL)
ATTN: NANCY BURKE PHONE NO : 425-487-7371 22100 BOTHELL EVERETT HIGHWAY SE DECISION MADE: 27-MAR-08 BOTHELL, WA 98021 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: XTRAC ULTRA 2, MODEL AL10000 PHOTO MEDEX, INC. 510(k) NO: K073659(TRADITIONAL)
ATTN: JEFF LEVATTER PHONE NO : 760-602-3300 2375 CAMINO VIDA ROBLE, SE DECISION MADE: 05-MAR-08 SUITE B 510(k) SUMMARY AVAILABLE FROM FDA CARLSBAD, CA 92011 DEVICE: OMNILUX NEW-U PHOTO THERAPEUTICS, INC. 510(k) NO: K072459(TRADITIONAL)
ATTN: SUE DARCY PHONE NO : 780-607-0488 2720 LOKER AVENUE WEST SE DECISION MADE: 03-MAR-08 CARLSBAD, CA 92010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PIONEER LOWTOP SPINAL ROD SYSTEM PIONEER SURGICAL TECHNOLOGY 510(k) NO: K080504(SPECIAL)
ATTN: JONATHAN M GILBERT PHONE NO : 906-226-4812 375 RIVER PARK CIRCLE SE DECISION MADE: 20-MAR-08 MARQUETTE, MI 49855-0627 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM PIONEER SURGICAL TECHNOLOGY 510(k) NO: K080518(SPECIAL)
ATTN: JONATHAN M GILBERT PHONE NO : 906-226-4812 375 RIVER PARK CIRCLE SE DECISION MADE: 20-MAR-08 MARQUETTE, MI 49855-0627 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SWIFT LT RESMED LTD. 510(k) NO: K073638(TRADITIONAL)
ATTN: DAVID D'CRUZ PHONE NO : 858-746-2238 14040 DANIELSON ST. SE DECISION MADE: 20-MAR-08 POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RESPIRONICS GOLOX RESPIRONICS, INC. 510(k) NO: K072723(TRADITIONAL)
ATTN: ZITA A YURKO PHONE NO : 724-387-4120 1740 GOLDEN MILE HIGHWAY SE DECISION MADE: 20-MAR-08 MONROEVILLE, PA 15146 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PORTRAIT PSR, MODEL 745915 RHYTEC INCORPORATED 510(k) NO: K073111(TRADITIONAL)
ATTN: ROBERT ZOLETTI PHONE NO : 781-419-9482 130 TURNER STREET SE DECISION MADE: 27-MAR-08 BUILDING 2 510(k) SUMMARY AVAILABLE FROM FDA WALTHAM, MA 02453 DEVICE: PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIE RJ MEDICAL, INC. 510(k) NO: K073544(TRADITIONAL)
ATTN: JIM INNES PHONE NO : 916-941-6913 4921 ROBERT J. MATHEWS PKWY SE DECISION MADE: 05-MAR-08 #2 510(k) SUMMARY AVAILABLE FROM FDA EL DORADO HILLS, CA 95762 DEVICE: COBAS LITHIUM ROCHE DIAGNOSTICS CORP. 510(k) NO: K063684(TRADITIONAL)
ATTN: THERESA AMBROSE BUSH PHONE NO : 317-521-3723 9115 HAGUE RD. SE DECISION MADE: 21-MAR-08 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROCHE-CREACTIVE PROTEIN (LATEX) ROCHE DIAGNOSTICS CORP. 510(k) NO: K073277(SPECIAL)
ATTN: KERWIN L KAUFMAN PHONE NO : 317-521-7637 9115 HAGUE RD. SE DECISION MADE: 06-MAR-08 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTR ROCHE DIAGNOSTICS CORP. 510(k) NO: K080183(ABBREVIATED)
ATTN: DIMITRIS DEMIRTZOGLOU PHONE NO : 317-521-7688 9115 HAGUE RD. BX 50416 SE DECISION MADE: 25-MAR-08 INDIANAPOLIS, IN 46250-0416 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SALVIN DENTAL SPECIALTIES, INC., FIXATION SCREW SALVIN DENTAL SPECIALTIES, INC. 510(k) NO: K073342(TRADITIONAL)
ATTN: ROBERT SALVIN PHONE NO : 704-442-5400 3450 LATROBE DR. SE DECISION MADE: 26-MAR-08 CHARLOTTE, NC 28211 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SANARUS INCORE ROTATIONAL CORE BIOPSY DEVICE, MODELS CB3010, CB3 SANARUS MEDICAL, INC. 510(k) NO: K080171(TRADITIONAL)
ATTN: LISA HENRY PHONE NO : 925-460-5732 4696 WILLOW RD. SE DECISION MADE: 06-MAR-08 PLEASANTON, CA 94588 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GEL MARK ULTRACOR BIOPSY SITE MARKER, MODEL: GMUC-17GGP SENORX, INC. 510(k) NO: K080698(SPECIAL)
ATTN: EBEN GORDON PHONE NO : 949-362-4800 11 COLUMBIA SE DECISION MADE: 31-MAR-08 ALISO VIEJO, CA 92656 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NON-STERILE, POWDER-FREE, BLACK NITRILE EXAMINATION GLOVES SGMP CO., LTD. 510(k) NO: K072400(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612 198 AVENUE DE LA D'EMERALD SE DECISION MADE: 27-MAR-08 SPARKS, NV 89434 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NON-STERILE, POWDERED, PINK LATEX EXAMINATION GLOVES WITH CHERRY SGMP CO., LTD. 510(k) NO: K072403(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612 198 AVENUE DE LA D'EMERALD SE DECISION MADE: 27-MAR-08 SPARKS, NV 89434 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NON-STERILE, POWDER FREE, PINK LATEX EXAMINATION GLOVES WITH CHE SGMP CO., LTD. 510(k) NO: K072406(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612 198 AVENUE DE LA D'EMERALD SE DECISION MADE: 21-MAR-08 SPARKS, NV 89434 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODEL TW SB, SCALP VEIN SET; MODEL TW LB, STERILE HYPODERMIC NEE SHANDONG QAIOPAI GROUP COMPANY, LT510(k) NO: K073705(TRADITIONAL)
ATTN: PHONE NO : NO 13 QUINGHE ROAD SE DECISION MADE: 24-MAR-08 GAOQING, SHANGDONG, CHINA 518054 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: JIERUI SYRINGES AND NEEDLES SHANDONG WEIGAO GROUP MEDICAL POLY510(k) NO: K072739(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 021 642 64467 SUITE 8D, NO.19, LANE 999 SE DECISION MADE: 21-MAR-08 ZHONGSHAN NO.2 ROAD(S) 510(k) SUMMARY AVAILABLE FROM FDA SHANGHAI, CHINA 200030 DEVICE: M5 DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K080640(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 949-429-5825 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 21-MAR-08 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: BONE FIXATION WIRE (KIRSCHNER WIRE) SIGNAL MEDICAL CORP. 510(k) NO: K073674(TRADITIONAL)
ATTN: LOUIS A SERAFIN PHONE NO : 810-364-7070 400 PYRAMID DR. SE DECISION MADE: 24-MAR-08 MARYSVILLE, MI 48040 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KIMBA MINI SIGNUS MEDIZINTECHNIK GMBH 510(k) NO: K080349(SPECIAL)
ATTN: ALAN ALEXANDER PHONE NO : 763-287-3830 4050 OLSON MEMORIAL HWY SE DECISION MADE: 10-MAR-08 SUITE 350 510(k) SUMMARY AVAILABLE FROM FDA MINNEAPOLIS, MN 55422 DEVICE: SBI SR MTP TOE IMPLANT SMALL BONE INNOVATIONS INC. 510(k) NO: K073635(TRADITIONAL)
ATTN: JEFFREY ZIGLER PHONE NO : 202-552-5800 1331 H STREET NW, 12TH FL SE DECISION MADE: 19-MAR-08 WASHINGTON, DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JET-X BAR SYSTEM CLAMPS, BARS AND POSTS-MR SAFE SMITH & NEPHEW, INC. 510(k) NO: K072212(SPECIAL)
ATTN: DAVID HENLEY PHONE NO : 901-399-6487 1450 BROOKS RD. SE DECISION MADE: 07-MAR-08 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TWINFIX PK FP SUTURE ANCHOR SMITH & NEPHEW, INC. 510(k) NO: K073509(TRADITIONAL)
ATTN: DEANA BOUSHELL PHONE NO : 508-337-4036 150 MINUTEMAN RD. SE DECISION MADE: 04-MAR-08 ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SMITHS MEDICAL MD, INC. 510(k) NO: K072144(TRADITIONAL)
ATTN: PHIL NEURURER PHONE NO : 651-628-7592 1265 GREY FOX RD. SE DECISION MADE: 07-MAR-08 ARDEN HILLS, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PREVADH MESH SOFRADIM PRODUCTION 510(k) NO: K073287(TRADITIONAL)
ATTN: SHARON ALEXANDER PHONE NO : 203-492-6060 60 MIDDLETOWN AVENUE SE DECISION MADE: 13-MAR-08 NORTH HAVEN, CT 06473 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TUMARK PROFESSIONAL, MODEL 271560; MR- TUMARK PROFESSIONAL, MODE SOMATEX MEDICAL TECHNOLOGIES GMBH 510(k) NO: K073095(TRADITIONAL)
ATTN: SUSANNE RAAB PHONE NO : 617-547-0628 1480 CAMBRIDGE STREET SE DECISION MADE: 19-MAR-08 CAMBRIDGE, MA 02139 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PSS SYSTEM SPINAL USA 510(k) NO: K073240(SPECIAL)
ATTN: JEFFREY JOHNSON PHONE NO : 601-420-4244 644 LAKELAND EAST DR., STE. A SE DECISION MADE: 20-MAR-08 FLOWOOD, MS 39232 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DUREX PLAY MASSAGE GEL LUBRICANT SSL AMERICAS, INC. 510(k) NO: K063385(TRADITIONAL)
ATTN: CHRIS ROBINSON PHONE NO : 770-582-2152 3585 ENGINEERING DR. SE DECISION MADE: 10-MAR-08 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA NORCROSS, GA 30092 DEVICE: ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM ST. JUDE MEDICAL, CARDIAC RHYTHM M510(k) NO: K072864(TRADITIONAL)
ATTN: COLLEEN CANAN PHONE NO : 818-493-2960 15900 VALLEY VIEW CT. SE DECISION MADE: 13-MAR-08 SYLMAR, CA 91342 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM STAAR SURGICAL CO. 510(k) NO: K073586(TRADITIONAL)
ATTN: DIANA SMITH PHONE NO : 626-303-7902 1911 WALKER AVE. SE DECISION MADE: 13-MAR-08 MONROVIA, CA 91016 510(k) STATEMENT DEVICE: MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM STAAR SURGICAL CO. 510(k) NO: K073591(TRADITIONAL)
ATTN: DIANA SMITH PHONE NO : 626-303-7902 1911 WALKER AVE. SE DECISION MADE: 13-MAR-08 MONROVIA, CA 91016 510(k) STATEMENT DEVICE: MUSCLE PAIN DEVICE (MPD) STEVENS PROOF OF CONCEPT, INC. 510(k) NO: K073361(TRADITIONAL)
ATTN: JECKIN D SHAH PHONE NO : 203-921-0352 68 SOUTHFIELD AVE. STE 100-2 SE DECISION MADE: 18-MAR-08 STAMFORD LANDING 510(k) STATEMENT STAMFORD, CT 06902 THIRD PARTY REVIEW DEVICE: CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS STRAUMANN USA 510(k) NO: K080286(SPECIAL)
ATTN: ELAINE ALAN PHONE NO : 978-747-2513 60 MINUTEMAN ROAD SE DECISION MADE: 07-MAR-08 ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVS PL PEEK SPACERS, MODELS 48351 AND 48353 STRYKER CORP. 510(k) NO: K080758(SPECIAL)
ATTN: VIKKI M O'CONNOR PHONE NO : 201-760-8145 2 PEARL COURT SE DECISION MADE: 27-MAR-08 ALLENDALE, NJ 07645 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRYKER ANTIMIC CATHETER STRYKER INSTRUMENTS, INSTRUMENTS D510(k) NO: K072702(TRADITIONAL)
ATTN: JULIE PRYOR PHONE NO : 269-323-7700 4100 EAST MILHAM AVE. SE DECISION MADE: 19-MAR-08 KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVS PL PEEK SPACERS, MODELS 48351XXX AND 48353XXX STRYKER SPINE 510(k) NO: K073470(TRADITIONAL)
ATTN: SIMONA VOIC PHONE NO : 201-760-8145 2 PEARL COURT SE DECISION MADE: 06-MAR-08 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INREACH SYSTEM SUPERDIMENSION, LTD. 510(k) NO: K080271(TRADITIONAL)
ATTN: JONATHAN KOVACH PHONE NO : 763-210-4015 161 CHESHIRE LANE NORTH, SE DECISION MADE: 31-MAR-08 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA MINNEAPOLIS, MN 55441-5433 DEVICE: QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOXANON SURGICAL SPECIALTIES CORP. 510(k) NO: K080680(SPECIAL)
ATTN: TRUDY D ESTRIDGE PHONE NO : 703-796-8927 13921 PARK CENTER RD. SE DECISION MADE: 21-MAR-08 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA HERNDON, VA 20171 DEVICE: SUTTER ELECTROSURGICAL CABLES SUTTER MEDIZINTECHNIK GMBH 510(k) NO: K073450(TRADITIONAL)
ATTN: THOMAS A BOONE PHONE NO : 505-977-9497 353 LOMA LARGA ROAD SE DECISION MADE: 17-MAR-08 CORRALES, NM 87048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNERGEYES HYBRID CONTACT LENSES-DAILY WEAR SYNERGEYES, INC. 510(k) NO: K080193(TRADITIONAL)
ATTN: RICHARD E LIPPMAN PHONE NO : 240-683-3738 15825 SHADY GROVE ROAD SE DECISION MADE: 05-MAR-08 SUITE 30 510(k) STATEMENT ROCKVILLE, MD 20850 DEVICE: QUANTITATIVE NEUROQ 3.0 SYNTERMED, INC. 510(k) NO: K072307(TRADITIONAL)
ATTN: KENNETH TRAIN PHONE NO : 714-281-1256 245 OWENS DR. SE DECISION MADE: 14-MAR-08 ANAHEIM, CA 92808 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES (USA) MODULAR BLADE PLATE SYSTEM SYNTHES (USA) 510(k) NO: K080109(TRADITIONAL)
ATTN: JILL R SHERMAN PHONE NO : 610-719-6538 1301 GOSHEN PKWY SE DECISION MADE: 20-MAR-08 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEVER CHEK MODEL TD-4232 BLOOD GLUCOSE MONITORING SYSTEM TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K073119(TRADITIONAL)
ATTN: ERICA LI PHONE NO : 886 2 66358080 4F, 88, SEC.1, KWANG FU ROAD SE DECISION MADE: 03-MAR-08 SAN CHUNG, TAIPEI, CHINA (TAIWAN) 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APX21 TECHDENT TECHNOLOGIES, LTD. 510(k) NO: K073185(TRADITIONAL)
ATTN: BENNY ARAZY PHONE NO : 972 4 9947880 MIZPE AVIV, INDUSTRIAL PARK 13 SE DECISION MADE: 06-MAR-08 M.P. MISGAV, ISRAEL 20187 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAPIOX CIRCUIT CONNECTORS TERUMO CORP. 510(k) NO: K073474(TRADITIONAL)
ATTN: GARRY COURTNEY PHONE NO : 800-283-7866 125 BLUE BALL RD. SE DECISION MADE: 05-MAR-08 ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEVICE MODIFICATION TO PINNACLE DESTINATION PERIPHERAL GUIDING S TERUMO MEDICAL CORP. 510(k) NO: K080415(SPECIAL)
ATTN: MARK UNTERREINER PHONE NO : 410-392-7213 950 ELKTON BLVD. SE DECISION MADE: 07-MAR-08 ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RUNTHROUGH NS EXTENSION WIRE TERUMO MEDICAL CORP. 510(k) NO: K080563(SPECIAL)
ATTN: MARK UNTERREINER PHONE NO : 410-392-7231 950 ELKTON BLVD. SE DECISION MADE: 20-MAR-08 ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INPLEX CF MOLECULAR TEST THIRD WAVE TECHNOLOGIES, INC. 510(k) NO: K063787(TRADITIONAL)
ATTN: ANDREW A LUKOWIAK PHONE NO : 608-273-8933 502 SOUTH ROSA RD. SE DECISION MADE: 13-MAR-08 MADISON, WI 53719-1256 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HOMECHECK MULTIPLE DRUG CUP TEST TIANJIN NEW BAY BIORESEARCH CO., L510(k) NO: K071489(TRADITIONAL)
ATTN: ARMANDO A TORRESCANO PHONE NO : 760-685-3658 3108 AVENIDA OLMEDA SE DECISION MADE: 28-MAR-08 CARLSBAD, CA 92009 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODEL TSX-101A/H/I AQUILION 32/64 SP CT SYSTEM TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K080211(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000 2441 MICHELLE DR. SE DECISION MADE: 14-MAR-08 P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA TUSTIN, CA 92781-2068 THIRD PARTY REVIEW DEVICE: TRANS1 FACET SCREW TRANS1 INCORPORATED 510(k) NO: K073515(TRADITIONAL)
ATTN: WILLIAM JACKSON PHONE NO : 910-332-1727 411 LANDMARK DR. SE DECISION MADE: 11-MAR-08 WILMINGTON, NC 28412 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENSITITRE 18-24 SUSCEPTIBILITY PLATE TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K073558(TRADITIONAL)
ATTN: CYNTHIA C KNAPP PHONE NO : 800-871-8909 982 KEYNOTE CIRCLE SUITE 6 SE DECISION MADE: 13-MAR-08 CLEVELAND, OH 44131 510(k) STATEMENT DEVICE: SENSITITRE 18 - 24 HOUR SUSCEPTIBILITY PLATE TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K073653(TRADITIONAL)
ATTN: CYNTHIA C KNAPP PHONE NO : 216-351-8735 982 KEYNOTE CIRCLE SUITE 6 SE DECISION MADE: 20-MAR-08 CLEVELAND, OH 44131 510(k) STATEMENT DEVICE: EZ SCAN PLUS BLOOD GLUCOSE MONITORING SYSTEM TYSON BIORESEARCH, INC. 510(k) NO: K072441(TRADITIONAL)
ATTN: WEN-HAI TSAI PHONE NO : 886 375 85988 5F, #22, KE E. ROAD, III SE DECISION MADE: 25-MAR-08 SCIENCE-BASED INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA CHU-NAN, CHINA (TAIWAN) 350 DEVICE: CLARIVEIN CATHETER VASCULAR INSIGHTS LLC 510(k) NO: K071468(ABBREVIATED)
ATTN: JOHN P MARANO PHONE NO : 203-245-9120 395 BOSTON POST ROAD SE DECISION MADE: 20-MAR-08 MADISON, CT 06443 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VARI-LASE ENDOVENOUS LASER CONSOLE, MODEL 7542 VASCULAR SOLUTIONS, INC. 510(k) NO: K080104(TRADITIONAL)
ATTN: JAMES CHAPMAN PHONE NO : 763-656-4300 6464 SYCAMORE COURT NORTH SE DECISION MADE: 26-MAR-08 MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENOWAVE MODELS VW5-6, VW5-10, VW5-20 AND VW5-30 VENOWAVE, INC. 510(k) NO: K073028(TRADITIONAL)
ATTN: JOHN SARINGER PHONE NO : 905 888 1888 13231 KENNEDY ROAD SE DECISION MADE: 07-MAR-08 STOUFFVILLE, ONTARIO, CANADA L4A 7510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENTLAB NASAL CO2 SAMPLING/O2 DELIVERY CANNULA VENTLAB CORP. 510(k) NO: K063813(TRADITIONAL)
ATTN: JAMES A COCHIE PHONE NO : 336-753-5000 155 BOYCE DRIVE SE DECISION MADE: 26-MAR-08 MOCKSVILLE, NC 27028 510(k) STATEMENT DEVICE: VERTEBRON VBR SYSTEM VERTEBRON, INC. 510(k) NO: K073502(TRADITIONAL)
ATTN: LUIS NESPRIDO PHONE NO : 203-380-9340 80 HATHAWAY DRIVE SE DECISION MADE: 24-MAR-08 STRATFORD, CT 06615 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIRTUAL PORTS ENDOCLEAR SYSTEM VIRTUAL PORTS LTD 510(k) NO: K080051(TRADITIONAL)
ATTN: YORAM LEVY PHONE NO : 972 4 6388837 31 HAAVODA STREET SE DECISION MADE: 21-MAR-08 BINYAMINA, ISRAEL 30500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VS-VISIONSENSE STEREOSCOPIC VISION SYSTEM VISIONSENSE, LTD. 510(k) NO: K073279(SPECIAL)
ATTN: GERARD J PRUD'HOMME PHONE NO : 202-637-5735 555 13TH STREET, NW SE DECISION MADE: 05-MAR-08 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOYALA FULL FACE MASK GEL VENTED WEINMANN GERATE FUR MEDIZIN GMBH +510(k) NO: K073673(SPECIAL)
ATTN: RALF EGENOLF PHONE NO : 011 494 054802370 KRONSAALSWEG 40 SE DECISION MADE: 28-MAR-08 HAMBURG, GERMANY 22525 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COOK CLECT VENA CAVA FILTER, GUNTHER TULIP VENA CAVA FILTER RETR WILLIAM COOK EUROPE APS 510(k) NO: K073374(TRADITIONAL)
ATTN: MOLLY BUSENBARK PHONE NO : 812-339-2235 750 DANIELS WAY SE DECISION MADE: 07-MAR-08 P.O. BOX 489 510(k) SUMMARY AVAILABLE FROM FDA BLOOMINGTON, IN 47402-0489 DEVICE: OCCLUFAST CAD ZHERMACK S.P.A. 510(k) NO: K080130(SPECIAL)
ATTN: GERALD W SHIPPS PHONE NO : 541-389-5935 19379 BLUE LAKE LOOP SE DECISION MADE: 14-MAR-08 BEND, OR 97702 510(k) STATEMENT DEVICE: ZIEHM VISION ZIEHM IMAGING, INC. 510(k) NO: K073346(TRADITIONAL)
ATTN: RICHARD WESTRICH PHONE NO : 951-781-2020 4181 LATHAM ST. SE DECISION MADE: 21-MAR-08 RIVERSIDE, CA 92501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIMMER POROLOCK MIS STEM ZIMMER GMBH 510(k) NO: K071723(TRADITIONAL)
ATTN: DALENE T BINKLEY PHONE NO : 574-372-4907 P.O. BOX 708 SE DECISION MADE: 07-MAR-08 WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES ZIMMER GMBH 510(k) NO: K073567(TRADITIONAL)
ATTN: PATRICIA JENKS PHONE NO : 574-371-8354 P.O. BOX 708 SE DECISION MADE: 13-MAR-08 WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM ZIMMER, INC. 510(k) NO: K073286(TRADITIONAL)
ATTN: BRANDON HIPSHER PHONE NO : 574-371-8083 P.O. BOX 708 SE DECISION MADE: 07-MAR-08 WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTOPULSE RESUSCITATION SYSTEM, MODEL 100 ZOLL CIRCULATION 510(k) NO: K072527(TRADITIONAL) ATTN: MARK PERKINS PHONE NO : 408-541-2140 249 HUMBOLDT COURT SE DECISION MADE: 19-MAR-08 SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 234 TOTAL WITH SUMMARIES 211 TOTAL WITH STATEMENTS 23
Updated April 7, 2008
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