SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE) 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD 01-MAR-2007 THROUGH 31-MAR-2007 DEVICE: AUDIT MICROCV LIPIDS LINEARITY SET (LOW) AALTO SCIENTIFIC LTD. 510(k) NO: K070223(TRADITIONAL)
ATTN: ALAN VEKICH PHONE NO : 760-431-7922 1959 KELLOGG AVE. SE DECISION MADE: 13-MAR-07 CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DELUXE NEBULIZER ACCESS POINT MEDICAL, L.L.C. 510(k) NO: K063449(TRADITIONAL)
ATTN: JAMES W SANDBERG PHONE NO : 971-409-9186 835 NW PEBBLE BEACH WAY SE DECISION MADE: 01-MAR-07 BEAVERTON, OR 97006 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ZIRBLANK-PS AND ZIRBLANK-FS ACUCERA, INC. 510(k) NO: K070045(TRADITIONAL)
ATTN: KYUNG-BIN LEE PHONE NO : 82 31 5276940 539 JINBUL-LI SE DECISION MADE: 26-MAR-07 JINJEOP, NAMYANGJU 510(k) SUMMARY AVAILABLE FROM FDA GYEONGGI, REPUBLIC OF KOREA 472-861 DEVICE: ADVANTAGE CUFF, NON-INVASIVE BLOOD PRESSURE HOSE AND ADAPTER ADVANTAGE MEDICAL CABLES, INC. 510(k) NO: K063863(TRADITIONAL)
ATTN: KEN KENDRICKS PHONE NO : 954-345-9800 10630 WILES RD. SE DECISION MADE: 20-MAR-07 CORAL SPRINGS, FL 33076 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: S4 SPINAL SYSTEM AESCULAP 510(k) NO: K062085(SPECIAL)
ATTN: KATHY A RACOSKY PHONE NO : 610-984-9072 3773 CORPORATE PKWY. SE DECISION MADE: 02-MAR-07 CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO S4 SPINAL SYSTEM AESCULAP, INC. 510(k) NO: K062327(SPECIAL)
ATTN: LISA M BOYLE PHONE NO : 610-984-9072 3773 CORPORATE PKWY. SE DECISION MADE: 14-MAR-07 CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MONARCH III IOL DELIVERY SYSTEM ALCON MANUFACTURING, LTD. 510(k) NO: K063155(TRADITIONAL)
ATTN: CATHERINE G GOBLE PHONE NO : 817-551-6816 6201 SOUTH FREEWAY SE DECISION MADE: 27-MAR-07 FORT WORTH, TX 76134-2099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED PHACOEMULSIFICATION TIPS ALLIANCE MEDICAL CORP. 510(k) NO: K060648(TRADITIONAL)
ATTN: MOIIRA BARTON PHONE NO : 480-763-5394 10232 SOUTH 51ST ST. SE DECISION MADE: 19-MAR-07 PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REVOLIX 120 ALLMED SYSTEMS INC. 510(k) NO: K070476(SPECIAL)
ATTN: PETER ALLEN PHONE NO : 925-468-0433 9232 KLEMETSON DRIVE SE DECISION MADE: 26-MAR-07 PLEASANTON, CA 94588 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALPHA BIO DENTAL IMPLANT SYSTEM ALPHA-BIO TEC LTD 510(k) NO: K063364(TRADITIONAL)
ATTN: DANIEL J MANELLI PHONE NO : 202-885-5548 5335 WISCONSIN AVE. NW SE DECISION MADE: 14-MAR-07 SUITE 440 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20015 DEVICE: ALPHA BIO BONE FIXATION SCREW SYSTEM ALPHA-BIO TEC LTD 510(k) NO: K063769(TRADITIONAL)
ATTN: DANIEL J MANELLI PHONE NO : 202-885-5548 5335 WISCONSIN AVE. NW SE DECISION MADE: 30-MAR-07 SUITE 440 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20015 DEVICE: ALPHA-BIO ORTHODONTIC FIXATION SCREW SYSTEM ALPHA-BIO TEC LTD 510(k) NO: K063770(TRADITIONAL)
ATTN: DANIEL J MANELLI PHONE NO : 202-885-5548 5335 WISCONSIN AVE. NW SE DECISION MADE: 26-MAR-07 SUITE 440 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20015 DEVICE: NIGHT GUARD ALPINE ORAL CARE, LLC 510(k) NO: K061122(TRADITIONAL)
ATTN: CATHY TENG PHONE NO : 713-223-8899 4003 LEELAND SE DECISION MADE: 12-MAR-07 HOUSTON, TX 77003 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECG CABLES, TRUNK AND PATIENT LEAD WIRES AMERICAN I.V. PRODUCTS, INC. 510(k) NO: K070232(ABBREVIATED)
ATTN: JOHN TAYLOR PHONE NO : 410-787-1300 7485 SHIPLEY AVE. SE DECISION MADE: 27-MAR-07 HARMANS, MD 21077 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLINICAL ELECTRONIC THERMOMETER, MODELS TP11403 THROUGH TP11413 AMERICAN I.V. PRODUCTS, INC. 510(k) NO: K070342(TRADITIONAL)
ATTN: JOHN TAYLOR PHONE NO : 414-787-1300 7485 SHIPLEY AVE. SE DECISION MADE: 19-MAR-07 HARMANS, MD 21077 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMS SINGLE INCISION SLING SYSTEM (SIS-0) AMERICAN MEDICAL SYSTEMS, INC. 510(k) NO: K070065(SPECIAL)
ATTN: BRAD ONSTAD PHONE NO : 952-933-6139 10700 BREN RD., WEST SE DECISION MADE: 01-MAR-07 MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANGIODYNAMICS, INC. 600UM FIBER AND VENACURE PROCEDURE KIT ANGIODYNAMICS, INC. 510(k) NO: K070378(SPECIAL)
ATTN: TERI JUCKETT PHONE NO : 518-798-1215 603 QUEENSBURY AVE. SE DECISION MADE: 09-MAR-07 QUEENSBURY, NY 12804 510(k) STATEMENT DEVICE: EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE ANIMAS CORP. 510(k) NO: K063674(TRADITIONAL)
ATTN: AMY SMITH PHONE NO : 610-644-8990 200 LAWRENCE DR. SE DECISION MADE: 30-MAR-07 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP 5W APOZA ENTERPRISE CO. LTD. 510(k) NO: K070373(SPECIAL)
ATTN: JENNIFER REICH PHONE NO : 928-773-6340 2904 N. BOLDT DR. SE DECISION MADE: 02-MAR-07 FLAGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARGON CONTINUOUS FLUSH DEVICE ARGON MEDICAL DEVICES INC. 510(k) NO: K070384(TRADITIONAL)
ATTN: AMY WINDHAM PHONE NO : 903-675-9321 1445 FLAT CREEK RD. SE DECISION MADE: 29-MAR-07 ATHENS, TX 75751 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHREX CROSSPIN, MODEL AR-1964P ARTHREX, INC. 510(k) NO: K063719(TRADITIONAL)
ATTN: ANN WATERHOUSE PHONE NO : 239-643-5553 1370 CREEKSIDE BLVD. SE DECISION MADE: 06-MAR-07 NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VAP-NT CHOLESTEROL TEST ATHEROTECH, INC. 510(k) NO: K062026(TRADITIONAL)
ATTN: REBECCA K PINE PHONE NO : 760-798-2274 15217 SPRINGDALE STREET SE DECISION MADE: 06-MAR-07 HUNTINGTON BEACH, CA 92649 510(k) STATEMENT DEVICE: ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN INTERFACE ATLANTIS COMPONENTS, INC. 510(k) NO: K063734(TRADITIONAL)
ATTN: BETSY A BROWN PHONE NO : 847-560-4406 8944 TAMAROA TERRACE SE DECISION MADE: 02-MAR-07 SKOKIE, IL 60076 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATLAS SPINE VERTEBRAL BODY REPLACEMENT ATLAS SPINE INC. 510(k) NO: K063464(TRADITIONAL)
ATTN: JEANNETTE G DAILEY PHONE NO : 561-354-4319 1555 JUPITER PARK DR., STE. 4 SE DECISION MADE: 09-MAR-07 JUPITER, FL 33458 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATRIUM PROLITE ULTRA S MESH ATRIUM MEDICAL CORP. 510(k) NO: K070192(SPECIAL)
ATTN: JOSEPH P DE PAOLO PHONE NO : 603-880-1433 5 WENTWORTH DR. SE DECISION MADE: 08-MAR-07 HUDSON, NH 03051 510(k) STATEMENT DEVICE: AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MO AXIS-SHIELD DIAGNOSTICS, LTD. 510(k) NO: K063347(TRADITIONAL)
ATTN: ERICA CONWAY PHONE NO : 44 13 824 THE TECHNOLOGY PARK SE DECISION MADE: 20-MAR-07 DUNDEE, SCOTLAND, UNITED KINGDOM D510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRASOUND SCANNER PROFOCUS, MODEL 2202 B-K MEDICAL APS 510(k) NO: K070077(TRADITIONAL)
ATTN: VILLY BRAENDER PHONE NO : 011 45 44528100 MILEPARKEN 34 SE DECISION MADE: 05-MAR-07 HERLEV, DENMARK DK-2730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FISSO HOLDING SYSTEM BAITELLA AG 510(k) NO: K070509(TRADITIONAL)
ATTN: ANGELIKA SCHERP PHONE NO : 312 042 89591 AMSTEL 320-I SE DECISION MADE: 22-MAR-07 AMSTERDAM, NETHERLANDS 1017AP 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIO 5MP-21 AND MDNG-5121 CB BARCOVIEW 510(k) NO: K062621(TRADITIONAL)
ATTN: LIEVEN DE WANDEL PHONE NO : 32 56 233459 35 PRESIDENT KENNEDYPARK SE DECISION MADE: 19-MAR-07 KORTRIJK, BELGIUM B-8500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28 BAUSCH & LOMB, INC. 510(k) NO: K063694(SPECIAL)
ATTN: NANETTE CANEPA PHONE NO : 909-971-5394 180 VIA VERDE DR. SE DECISION MADE: 07-MAR-07 SAN DIMAS, CA 91773 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPEATER PUMP II TUBE SETS BAXA CORP. 510(k) NO: K062909(TRADITIONAL)
ATTN: KIMBERLY ZIZIK PHONE NO : 303-617-2242 14445 GRASSLANDS DR. SE DECISION MADE: 09-MAR-07 ENGLEWOOD, CO 80112-7062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRA LOW PROFILE RONGEUR BAXANO, INC. 510(k) NO: K062711(TRADITIONAL)
ATTN: SHARON ROCKWELL PHONE NO : 714-695-9269 5582 CHALON ROAD SE DECISION MADE: 07-MAR-07 YORBA LINDA, CA 92886 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD DIRECTIGEN EZ FLU A+B TEST BECTON DICKINSON & CO. 510(k) NO: K063689(TRADITIONAL)
ATTN: DAINELLE N CLARK PHONE NO : 410-316-4905 7 LOVETON CIR. SE DECISION MADE: 07-MAR-07 SPARKS, MD 21152 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD HYPOINT NEEDLE BECTON DICKINSON & CO. 510(k) NO: K070440(SPECIAL)
ATTN: AILEEN C GILBERT PHONE NO : 201-847-7197 1 BECTON DR. SE DECISION MADE: 16-MAR-07 FRANKLIN LAKES, NJ 07417-1880 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- MINOCYCLINE (GN) BECTON, DICKINSON & CO. 510(k) NO: K063486(TRADITIONAL)
ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287 7 LOVETON CIR. SE DECISION MADE: 07-MAR-07 SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SLENDERTONE SYSTEM ABS, MODELS 390, E10, X10; SLENDERTONE SYSTEM BIO-MEDICAL REASEARCH LTD. 510(k) NO: K070142(TRADITIONAL)
ATTN: ANNE-MARIE KEENAN PHONE NO : 353 91 774300 PARKMORE BUSINESS PARK WEST SE DECISION MADE: 23-MAR-07 GALWAY, IRELAND 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOPLEX 2200 SYPHILIS IGG KIT ON THE BIOPLEX 2200 MULTI-ANALYTE BIO-RAD LABORATORIES 510(k) NO: K063866(TRADITIONAL)
ATTN: DAVID BHEND PHONE NO : 425-881-8300 6565 185TH AVE, NE SE DECISION MADE: 19-MAR-07 REDMOND, WA 98052 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RADIESSE LARYNGEAL IMPLANT BIOFORM MEDICAL, INC. 510(k) NO: K070090(SPECIAL)
ATTN: JAMES MILLER PHONE NO : 650-286-4040 1875 SOUTH GRANT ST.,SUITE 11O SE DECISION MADE: 01-MAR-07 SAN MATEO, CA 94402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LATERALIZED TAPERLOC MICROPLASTY FEMORAL COMPONENTS BIOMET MANUFACTURING CORP. 510(k) NO: K062994(SPECIAL)
ATTN: PATRICIA S BERES PHONE NO : 574-267-6639 PO BOX 587 SE DECISION MADE: 09-MAR-07 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REGENERX RINGLOC + MODULAR ACETABULAR SHELLS BIOMET, INC. 510(k) NO: K070369(SPECIAL)
ATTN: ROBERT FRIDDLE PHONE NO : 574-267-6639 56 EAST BELL DR. SE DECISION MADE: 09-MAR-07 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS BIOSITE INCORPORATED 510(k) NO: K062840(TRADITIONAL)
ATTN: FIL V BUENVIAJE PHONE NO : 858-805-2722 9975 SUMMERS RIDGE RD SE DECISION MADE: 01-MAR-07 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DRILL FOR BLUE SKY BIO DENTAL IMPLANT SYSTEM BLUE SKY BIO, LLC 510(k) NO: K063874(TRADITIONAL)
ATTN: MICHELE VOVOLKA PHONE NO : 847-548-8499 888 E BELVIDERE RD. SE DECISION MADE: 29-MAR-07 SUITE 212 510(k) SUMMARY AVAILABLE FROM FDA GRAYSLAKE, IL 60030 DEVICE: UNITY ALPHA SYSTEM BONUTTI RESEARCH, INC. 510(k) NO: K062820(TRADITIONAL)
ATTN: PATRICK G BALSMANN PHONE NO : 217-343-3412 2600 SOUTH RANEY SE DECISION MADE: 15-MAR-07 P.O. BOX 1367 510(k) SUMMARY AVAILABLE FROM FDA EFFINGHAM, IL 62401 DEVICE: MODIFICATION TO POLAR CARE 500 BREG, INC. 510(k) NO: K070402(SPECIAL)
ATTN: KATHLEEN BARBER PHONE NO : 760-599-5719 2611 COMMERCE WAY SE DECISION MADE: 29-MAR-07 VISTA, CA 92083 510(k) STATEMENT DEVICE: ABLE GLOVE LATEX POWDERED EXAMINATION GLOVES BRIGHT ELEMENT SDN BHD 510(k) NO: K063776(TRADITIONAL)
ATTN: SEOW LAW AUDIE PHONE NO : 603 339 28588 NO 5, JALAN USJ 3B/2 SE DECISION MADE: 02-MAR-07 SUBANG JAYA, SELANGOR, MALAYSIA 4510(k) STATEMENT DEVICE: AVAULTA SUPPORT SYSTEM/AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM C.R. BARD, INC. 510(k) NO: K063712(TRADITIONAL)
ATTN: JOHN C KNORPP PHONE NO : 678-342-4920 13183 HARLAND DRIVE SE DECISION MADE: 12-MAR-07 COVINGTON, GA 30014-6421 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALIGN URETHRAL SUPPORT SYSTEM C.R. BARD, INC. 510(k) NO: K070073(TRADITIONAL) ATTN: JULIE J BASSETT PHONE NO : 678-342-4921 13183 HARLAND DRIVE SE DECISION MADE: 21-MAR-07 COVINGTON, GA 30014-6421 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BARDEX LUBRI-SIL ALL-SILICONE LUBRICIOUS COATED FOLEY CATHETER 6 C.R. BARD, INC. 510(k) NO: K070508(TRADITIONAL)
ATTN: MICHELLE GUDITH PHONE NO : 770-784-6722 8195 INDUSTRIAL BLVD. SE DECISION MADE: 09-MAR-07 COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: C.T.M. MOBILITTY SCOOTER # HS-295 C.T.M. HOMECARE PRODUCT, INC. 510(k) NO: K070603(TRADITIONAL)
ATTN: LINDA J BOVARD PHONE NO : 541-345-5431 29611 SIMMONS ROAD SE DECISION MADE: 20-MAR-07 EUGENE, OR 97405 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CADWELL EASYNET OXIMETER MODULE CADWELL LABORATORIES, INC. 510(k) NO: K061706(TRADITIONAL) ATTN: CHRIS BOLKAN PHONE NO : 509-735-6481 909 NORTH KELLOGG ST. SE DECISION MADE: 05-MAR-07 KENNEWICK, WA 99336 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTI CAMSIGHT CO., INC. 510(k) NO: K063646(TRADITIONAL)
ATTN: JAY CHOI PHONE NO : 323-259-1900 3380 SAN FERNADO ROAD SE DECISION MADE: 07-MAR-07 LOS ANGELES, CA 90065 510(k) STATEMENT DEVICE: BIOMARC GOLD TISSUE MARKER CARBON MEDICAL TECHNOLOGIES, INC. 510(k) NO: K070436(SPECIAL)
ATTN: ROBERT W JOHNSON PHONE NO : 651-762-2146 1290 HAMMOND RD. SE DECISION MADE: 16-MAR-07 ST. PAUL, MN 55110 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVACOAT SINUS GEL AND STENT CARBYLAN BIOSURGERY 510(k) NO: K070496(SPECIAL)
ATTN: ROXANNE DUBOIS PHONE NO : 650-855-6775 3181 PORTER DRIVE SE DECISION MADE: 15-MAR-07 PALO ALTO, CA 94304 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C-PORT FLEXA DISTAL ANASTOMOSIS SYSTEM CARDICA, INC. 510(k) NO: K070548(SPECIAL)
ATTN: TIFFINI LALUDE PHONE NO : 650-331-7153 900 SAGINAW DR. SE DECISION MADE: 29-MAR-07 REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDIOMEMS ENDOSURE WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MO CARDIOMEMS INC 510(k) NO: K070448(ABBREVIATED)
ATTN: GRACE POWERS PHONE NO : 404-920-6719 75 FIFTH ST., NW SE DECISION MADE: 15-MAR-07 SUITE 440 510(k) SUMMARY AVAILABLE FROM FDA ATLANTA, GA 30308 DEVICE: BOOMERANG WIRE /BOOMERANG PLUS WIRE SYSTEM, MODEL# B PLUS WIRE 5 CARDIVA MEDICAL, INC. 510(k) NO: K070485(SPECIAL)
ATTN: MICHAEL J BILLIG PHONE NO : 408-400-0856 155 MOFFETT PARK DR., SE DECISION MADE: 22-MAR-07 SUITE A-101 510(k) SUMMARY AVAILABLE FROM FDA SUNNYVALE, CA 94089 DEVICE: XPERT EV, MODEL GXEV-100N-10; GENEXPERT DX SYSTEM, MODELS P/N 90 CEPHEID 510(k) NO: K061062(TRADITIONAL) ATTN: RUSSEL K ENNS, PH.D. PHONE NO : 408-400-8230 904 CARIBBEAN DRIVE SE DECISION MADE: 09-MAR-07 SUNNYVALE, CA 94089-1189 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CERNER PROVISION WORKSTATION CERNER CORP. 510(k) NO: K070394(TRADITIONAL)
ATTN: SHELLEY S LOOBY PHONE NO : 816-201-1368 2800 ROCKCREEK PKWY. SE DECISION MADE: 27-MAR-07 KANSAS CITY, MO 64117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CTBOX CERVICAL/LUMBAR TRACTION CIRCULAR TRACTION SUPPLY, INC. 510(k) NO: K063353(TRADITIONAL)
ATTN: DONALD W MEYER PHONE NO : 714-847-8334 7602 TALBERT AVENUE, UNIT #9 SE DECISION MADE: 14-MAR-07 HUNTINGTON BEACH, CA 92648 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CISBIO RENIN RIA TEST CIS BIO INTERNATIONAL 510(k) NO: K062120(TRADITIONAL)
ATTN: GARY LEHNUS PHONE NO : 570-620-0198 150 CHERRY LANE ROAD SE DECISION MADE: 30-MAR-07 EAST STROUDSBURG, PA 18301 510(k) STATEMENT DEVICE: CO2 LASER SYSTEM, MODEL C-LAS CLINICON CORP. 510(k) NO: K063698(TRADITIONAL)
ATTN: KIM BLOOM PHONE NO : 858-675-8200 16787 BERNARDO CENTER DR. SE DECISION MADE: 02-MAR-07 SUITE A 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92128 DEVICE: MODIFICATION TO COLLAWOUND DRESSING COLLAMATRIX CO., INC. 510(k) NO: K070269(SPECIAL)
ATTN: DENNIS J SEAH PHONE NO : 886 277 209988 NO. 360 RUIGUANG ROAD, 2ND FL. SE DECISION MADE: 02-MAR-07 NEIHU DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA TAIPEI, CHINA (TAIWAN) 114 DEVICE: CONCEIVEX CONCEPTION KIT CONCEIVEX INC. 510(k) NO: K063227(TRADITIONAL)
ATTN: BLIX WINSTON PHONE NO : 301-607-9185 2600 MULLINIX MILL ROAD SE DECISION MADE: 14-MAR-07 MT. AIRY, MD 21771 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONFORMIS METAL BACKED TIBIAL COMPONENT("MBT") CONFORMIS, INC. 510(k) NO: K063432(TRADITIONAL)
ATTN: MICHAEL SHARP PHONE NO : 650-292-3636 323-C VINTAGE PARK DR. SE DECISION MADE: 16-MAR-07 FOSTER CITY, CA 94404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MATRYX INTERFERENCE SCREW, 239038T5,231025T5,231033T5,231038T5,2 CONMED LINVATEC BIOMATERIALS 510(k) NO: K063588(TRADITIONAL)
ATTN: PAIVI MESIRANTA PHONE NO : 358 331 65600 P.O. BOX 3 SE DECISION MADE: 02-MAR-07 HERMIANKATU 6-8L 510(k) SUMMARY AVAILABLE FROM FDA TAMPERE, FINLAND FIN-33720 DEVICE: CORDIS AMILA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CORDIS EUROPA, N.V. 510(k) NO: K063563(TRADITIONAL)
ATTN: JOAN MARTIN PHONE NO : 908-412-7250 7 POWDER HORN DRIVE SE DECISION MADE: 07-MAR-07 WARREN, NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO HYPERTRANSIT INFUSION CATHETER CORDIS NEUROVASCULAR, INC. 510(k) NO: K070279(SPECIAL)
ATTN: ROBERTO F REFECA PHONE NO : 786-313-2850 14000 N.W. 57TH CT. SE DECISION MADE: 14-MAR-07 MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CUTERA ER:YSGG LASER HANDPIECE CUTERA, INC. 510(k) NO: K063867(TRADITIONAL)
ATTN: CONNIE HOY PHONE NO : 415-657-5586 3240 BAYSHORE BLVD SE DECISION MADE: 27-MAR-07 BRISBANE, CA 94005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CUTERA ER:YAG LASER HANDPIECE CUTERA, INC. 510(k) NO: K070138(TRADITIONAL)
ATTN: CONNIE HOY PHONE NO : 415-657-5586 3240 BAYSHORE BLVD SE DECISION MADE: 27-MAR-07 BRISBANE, CA 94005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ONDEMAND3D CYBERMED, INC. 510(k) NO: K070464(TRADITIONAL)
ATTN: SONG N CHOI PHONE NO : 822 339 73970 #504 SJ TECHNOVILLE, SE DECISION MADE: 16-MAR-07 GASAN-DONG 60-19, GEUMCHEON-GU 510(k) SUMMARY AVAILABLE FROM FDA SEOUL, REPUBLIC OF KOREA 153-710 THIRD PARTY REVIEW DEVICE: STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK DADE BEHRING, INC. 510(k) NO: K063356(TRADITIONAL)
ATTN: PAMELA A JURGA PHONE NO : 302-631-8891 P.O. BOX 6101 BLDG 500;M.S.514 SE DECISION MADE: 23-MAR-07 NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIMENSION VISTA STFR FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBR DADE BEHRING, INC. 510(k) NO: K063663(TRADITIONAL)
ATTN: KATHLEEN DRAY-LYONS PHONE NO : 781-826-4551 P.O. BOX 6101 SE DECISION MADE: 21-MAR-07 NEWARK,, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIMENSION VISTA CTNI FLEX REAGENT CARTRIDGE DADE BEHRING, INC. 510(k) NO: K063756(TRADITIONAL)
ATTN: GEORGE M PLUMMER PHONE NO : 302-631-9798 BLDG. 500 MAIL BOX 514 SE DECISION MADE: 19-MAR-07 P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: TOP FINE INSULIN SYRINGE DAEJIN TECH MEDICAL MANUFACTURING 510(k) NO: K063348(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854 P.O. BOX 7007 SE DECISION MADE: 01-MAR-07 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TOP FINE DAEJIN TECH MEDICAL MANUFACTURING 510(k) NO: K063466(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854 P.O. BOX 7007 SE DECISION MADE: 02-MAR-07 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENS DEGANIA SILICONE, LTD. 510(k) NO: K063442(TRADITIONAL)
ATTN: ZOYA LEE PHONE NO : 972 4 670533 DEGANIA BET SE DECISION MADE: 26-MAR-07 EMEK HAYARDEN, ISRAEL 15130 510(k) STATEMENT DEVICE: ALPHA-CORE DC DENTAL TECHNOLOGIES, INC. 510(k) NO: K070191(TRADITIONAL)
ATTN: JANINE RAUHUT PHONE NO : 847-677-5500 6901 NORTH HAMLIN AVE. SE DECISION MADE: 07-MAR-07 LINCOLNWOOD, IL 60712 510(k) STATEMENT DEVICE: PAINT- ON POLISH AGENT DENTSPLY INTERNATIONAL, INC. 510(k) NO: K070306(TRADITIONAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511 SUSQUEHANNA COMMERCE CTR., 221 SE DECISION MADE: 22-MAR-07 W. PHILADELPHIA ST., SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA YORK, PA 17404 DEVICE: XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE DENTSPLY INTL. 510(k) NO: K070538(SPECIAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511 221 WEST PHILADELPHIA STREET SE DECISION MADE: 14-MAR-07 SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA YORK, PA 17404 DEVICE: DEPUY KNEE PROSTHESIS SYSTEM UNIVERSAL STEM EXTENSIONS AND FEMOR DEPUY ORTHOPAEDICS, INC. 510(k) NO: K063633(TRADITIONAL)
ATTN: STEVEN J WENTWORTH PHONE NO : 574-371-4913 700 ORTHOPAEDIC DR. SE DECISION MADE: 02-MAR-07 P.O BOX 988 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0988 DEVICE: DEPUY ASR TAPER SLEEVE ADAPTER DEPUY ORTHOPAEDICS, INC. 510(k) NO: K070359(SPECIAL)
ATTN: RHONDA MYER PHONE NO : 574-371-4927 700 ORTHOPAEDIC DRIVE SE DECISION MADE: 06-MAR-07 WARSAW, IN 46582 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEM DIAMICS, INC. 510(k) NO: K062433(TRADITIONAL)
ATTN: PETER GOMBRICH PHONE NO : 415-883-0414 SIX HAMILTON LANDING SUITE 200 SE DECISION MADE: 16-MAR-07 NOVATO, CA 94949 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDIUS 1, 2 AND 3 XPO AND 2020TC SPECT IMAGING SYSTEMS DIGIRAD CORP. 510(k) NO: K070542(SPECIAL)
ATTN: JOEL TUCKEY PHONE NO : 858-726-1600 13950 STOWE DRIVE SE DECISION MADE: 23-MAR-07 POWAY, CA 92064-8803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TOTAL ETCH BONDING AGENT DMG USA, INC. 510(k) NO: K063444(ABBREVIATED)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552 5 WHITCOMB AVE. SE DECISION MADE: 20-MAR-07 AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TCA 5R / 5S DORNIER MEDTECH AMERICA, INC. 510(k) NO: K070123(TRADITIONAL)
ATTN: TIM THOMAS PHONE NO : 770-514-6163 1155 ROBERTS BLVD. SE DECISION MADE: 09-MAR-07 KENNESAW, GA 30144 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHI DUKAL CORP. 510(k) NO: K070407(TRADITIONAL)
ATTN: PATRICK J LAMB PHONE NO : 631-656-3800 5 PLANT AVE SE DECISION MADE: 26-MAR-07 HAUPPAUGE, NY 11788 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FREQUENCER, MODEL 1001 DYMEDSO INC. 510(k) NO: K063645(TRADITIONAL)
ATTN: JEAN BIGONEY PHONE NO : 802-885-8026 127 MAIN ST. SE DECISION MADE: 15-MAR-07 SPRINGFIELD, VT 05156 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUNPOLAR HEALTHLINE, MODEL 100; COMPFRESH, MODEL 200; NATUREX , E.C.I. USA CORPORATION 510(k) NO: K062873(TRADITIONAL)
ATTN: JAMES WANG PHONE NO : 314-432-5656 544 FAIRWAYS CIRCLE SE DECISION MADE: 20-MAR-07 SAINT LOUIS, MO 63141 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EDWARDS AQUALINE STERILE TUBING SET; EDWARDS AQUALINS STERILE TU EDWARDS LIFESCIENCES SERVICES GMBH510(k) NO: K063293(TRADITIONAL)
ATTN: NEIL R ARMSTRONG PHONE NO : 44 176 3222505 BUSINESS & TECHNOLOGY CENTER SE DECISION MADE: 23-MAR-07 BESSEMER DRIVE 510(k) SUMMARY AVAILABLE FROM FDA STEVENAGE, HERTSFORDSHIRE, UNITED KINGDOM SG1 2DX DEVICE: DERMA YAG EL.EN. ELECTRONIC ENGINEERING SPA 510(k) NO: K062762(TRADITIONAL)
ATTN: ANDREA TOZZI PHONE NO : 055 882 6807 17 VIA BALDANZESE SE DECISION MADE: 01-MAR-07 CALENZANO, ITALY 50041 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LEKSELL GAMMA KNIFE PERFEXION ELEKTA INSTRUMENT AB 510(k) NO: K063512(TRADITIONAL)
ATTN: ANDERS SKOGLUND PHONE NO : 46 8 58725400 KUNGSTENSGATAN 18 SE DECISION MADE: 05-MAR-07 PO BOX 7593 510(k) SUMMARY AVAILABLE FROM FDA STOCKHOLM, SWEDEN SE-103 93 DEVICE: CLAROS DENTAL LASER SYSTEM ELEXXION AG 510(k) NO: K063152(ABBREVIATED)
ATTN: JOHANNES MUELLER PHONE NO : 49 608 1443414 GROOSE LACHE 5 SE DECISION MADE: 07-MAR-07 WHERHEIM, GERMANY 61273 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOGASTRIC STOMAPHYX DEVICE AND ACCESSORIES ENDOGASTRIC SOLUTIONS, INC. 510(k) NO: K062875(TRADITIONAL)
ATTN: MICHAEL A DANIEL PHONE NO : 425-307-9200 8210 154TH AVE. NE SE DECISION MADE: 09-MAR-07 REDMOND, WA 98052 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ERCHONIA IOTO_240 ERCHONIA MEDICAL, INC. 510(k) NO: K062792(TRADITIONAL)
ATTN: KEVIN WALLS,RAC PHONE NO : 720-962-5412 13 RED FOX LANE SE DECISION MADE: 01-MAR-07 LITTLETON, CO 80127 510(k) STATEMENT DEVICE: MONTBLANC IMPLANTOLOGY CONTRA ANGLE CONTROL EST. ANTHOGYR 510(k) NO: K070084(SPECIAL)
ATTN: ERIC GENEVE PHONE NO : 33 045 0580237 164 RUE DES TROIS LACS SE DECISION MADE: 08-MAR-07 SALLANCHES, FRANCE 74700 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXACTECH NOVATION CROWN CUP AND LINERS EXACTECH, INC. 510(k) NO: K070479(SPECIAL)
ATTN: MARITZA ELIAS PHONE NO : 352-377-1140 2320 N.W. 66TH CT. SE DECISION MADE: 15-MAR-07 GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BALANCEBACK MOBILE INTUITIVE VNG SYSTEM FALL PREVENTION TECHNOLOGIES, LLC 510(k) NO: K070729(TRADITIONAL)
ATTN: FRANK SCARPINO PHONE NO : 937-434-5455 4601 GATEWAY CIRCLE SE DECISION MADE: 30-MAR-07 KETTERING, OH 45440 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: FAMILIES OF MASTER NEB, PRIMO NEB, SC03, NEB AID, 4.2.NEB, Q03, FLAEM NUOVA S.P.A. 510(k) NO: K062014(TRADITIONAL)
ATTN: MAUREEN O'CONNELL PHONE NO : 978-207-1245 5 TIMBER LANE SE DECISION MADE: 22-MAR-07 NORTH READING, MA 01864 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND 400 FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K070177(SPECIAL)
ATTN: JANET C KAY PHONE NO : 781-699-4475 920 WINTER ST. SE DECISION MADE: 29-MAR-07 WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FUJINON MODEL EG-530N TRANS NASAL INSERTION FUJINON, INC. 510(k) NO: K063316(TRADITIONAL)
ATTN: JOSEPH AZARY PHONE NO : 203-944-9320 543 LONG HILL AVENUE SE DECISION MADE: 16-MAR-07 SHELTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FUJINON ULTRASONIC ENDOSCOPE AND PROCESSOR, MODELS EG-530UR, EG- FUJINON, INC. 510(k) NO: K063847(TRADITIONAL)
ATTN: JOSEPH AZARY PHONE NO : 203-944-9320 543 LONG HILL AVENUE SE DECISION MADE: 01-MAR-07 SHELTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ISIS GALIL MEDICAL LTD. 510(k) NO: K070482(SPECIAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794 555 THIRTEENTH STREET, NW SE DECISION MADE: 20-MAR-07 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GRADIA DIRECT X GC AMERICA INC. 510(k) NO: K070190(TRADITIONAL)
ATTN: TERRY L JORITZ-LYONS PHONE NO : 708-926-3105 3737 WEST 127TH STREET SE DECISION MADE: 12-MAR-07 ALSIP, IL 60803 510(k) STATEMENT DEVICE: COE SOFT GC AMERICA, INC. 510(k) NO: K070697(SPECIAL)
ATTN: TERRY L JORITZ-LYONS PHONE NO : 708-597-0900 3737 WEST 127TH ST. SE DECISION MADE: 29-MAR-07 ALSIP, IL 60803 510(k) STATEMENT DEVICE: COE COMFORT GC AMERICA, INC. 510(k) NO: K070698(SPECIAL)
ATTN: TERRY L JORITZ-LYONS PHONE NO : 708-597-0900 3737 WEST 127TH ST. SE DECISION MADE: 29-MAR-07 ALSIP, IL 60803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PET VCAR GE HEALTHCARE 510(k) NO: K063324(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894 3000 N. GRANDVIEW BLVD W 1140 SE DECISION MADE: 23-MAR-07 WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX..01 WITH GE HEALTHCARE 510(k) NO: K070421(SPECIAL)
ATTN: JOEL KENT PHONE NO : 781-449-8685 86 PILGRIM ROAD SE DECISION MADE: 13-MAR-07 NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO CIC PRO CLINICAL INFORMATION CENTER GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K062976(SPECIAL)
ATTN: LISA M BAUMHARDT PHONE NO : 414-362-3242 8200 WEST TOWER AVE. SE DECISION MADE: 16-MAR-07 MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUADRA BLOC TENS, MODEL 101 GRADIENT TECHNOLOGIES, LLC 510(k) NO: K062547(TRADITIONAL)
ATTN: JOHN TOWNSEND PHONE NO : 901-767-2384 6000 POPLAR AVENUE SE DECISION MADE: 21-MAR-07 SUITE 400 510(k) SUMMARY AVAILABLE FROM FDA MEMPHIS, TN 38119 DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, WHITE, PINK, BLACK GX CORPORATION SDN BHD 510(k) NO: K070096(TRADITIONAL)
ATTN: FOO KHON PU PHONE NO : 603 329 16100 LOT 6487, BATU 5 3/4, SEMENTA SE DECISION MADE: 14-MAR-07 JALAN KAPAR 510(k) SUMMARY AVAILABLE FROM FDA KLANG, MALAYSIA 42100 DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE GX CORPORATION SDN BHD 510(k) NO: K070097(TRADITIONAL)
ATTN: FOO K PU PHONE NO : 603 329 16100 LOT 6487, BATU 5 3/4, SEMENTA SE DECISION MADE: 23-MAR-07 JALAN KAPAR 510(k) STATEMENT KLANG, MALAYSIA 42100 DEVICE: HASELMEIER PEN HASELMEIER SARL 510(k) NO: K070100(TRADITIONAL)
ATTN: MELISSA MAHALL PHONE NO : 240-674-7196 517 BENFIELD ROAD SE DECISION MADE: 21-MAR-07 SUITE 301 510(k) SUMMARY AVAILABLE FROM FDA SEVERNA PARK, MD 21146-2596 DEVICE: MODIFICATION TO HEALTH BUDDY APPLIANCE HEALTH HERO NETWORK, INC. 510(k) NO: K070543(SPECIAL)
ATTN: ROBIN BUSH PHONE NO : 650-779-9191 2000 SEAPORT BLVD, SUITE 400 SE DECISION MADE: 28-MAR-07 REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEARTWAY POWER TILT SEATING SYSTEM POWER CHAIR, MODEL# P16RT HEARTWAY MEDICAL PRODUCTS CO., LTD510(k) NO: K070489(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829 NO.58, FU-CHIUN ST. SE DECISION MADE: 14-MAR-07 HSIN-CHU CITY, CHINA (TAIWAN) 408 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEARTWAY POWER TILT SEATING SYSTEM POWER CHAIR, P17RT HEARTWAY MEDICAL PRODUCTS CO., LTD510(k) NO: K070493(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829 NO.58, FU-CHIUN ST. SE DECISION MADE: 23-MAR-07 HSIN-CHU CITY, CHINA (TAIWAN) 408 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVE, YELLOW HONG DI PLASTIC PRODUCTS CO, LTD. 510(k) NO: K070188(TRADITIONAL)
ATTN: KATHY LIU PHONE NO : 909-591-7888 3973 SCHAEFER AVE. SE DECISION MADE: 19-MAR-07 CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PCA CONSTRAINED ACETABULAR LINERS HOWMEDICA OSTEONICS CORP 510(k) NO: K063445(TRADITIONAL)
ATTN: FRANCISCO HARO PHONE NO : 201-831-5493 325 CORPORATE DR. SE DECISION MADE: 08-MAR-07 MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYSTEM 12 CONSTRAINED ACETABULAR LINERS HOWMEDICA OSTEONICS CORP 510(k) NO: K063550(TRADITIONAL)
ATTN: FRANCISCO HARO PHONE NO : 201-831-5493 325 CORPORATE DR. SE DECISION MADE: 08-MAR-07 MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SERIES II CONSTRAINED ACETABULAR LINERS HOWMEDICA OSTEONICS CORP 510(k) NO: K063552(TRADITIONAL)
ATTN: FRANCISCO HARO PHONE NO : 201-831-5493 325 CORPORATE DR. SE DECISION MADE: 08-MAR-07 MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRYKER FOOT PLATING SYSTEM HOWMEDICA OSTEONICS CORP. 510(k) NO: K063875(TRADITIONAL)
ATTN: VIVIAN KELLY PHONE NO : 201-831-5581 325 CORPORATE DRIVE SE DECISION MADE: 15-MAR-07 MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIODENT MICRO DENTAL LASER SYSTEM, MODELS 810 AND 980 HOYA CONBIO, INC 510(k) NO: K063384(TRADITIONAL)
ATTN: LIZA BURNS PHONE NO : 209-586-0416 19722 WESTVIEW DRIVE SE DECISION MADE: 16-MAR-07 TWAIN HARTE, CA 95383 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPIROS ICU MEDICAL, INC 510(k) NO: K070532(SPECIAL)
ATTN: MARTIN MAIER PHONE NO : 801-264-1438 4455 ATHERTON DR. SE DECISION MADE: 20-MAR-07 SALT LAKE CITY, UT 84123 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMPEDIMED-EXTRACELLULAR FLUID ANALYSIS IMPEDIMED PTY LTD. 510(k) NO: K050415(TRADITIONAL) ATTN: NEVILLE BERTWISTLE PHONE NO : 617 342 31777 BUILDING 4B/2404 LOGAN ROAD SE DECISION MADE: 30-MAR-07 EIGHT MILE PLAINS 510(k) SUMMARY AVAILABLE FROM FDA BRISBANE, QUEENSLAND, AUSTRALIA 4113 DEVICE: CONICAL ANGLED ABUTMENT IMPLANT INNOVATIONS, INC. 510(k) NO: K063403(TRADITIONAL)
ATTN: TAMARA NELSON PHONE NO : 561-776-6923 4555 RIVERSIDE DR. SE DECISION MADE: 20-MAR-07 PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMPLANT SCIENCES CORP. MODEL HDR 4454 IMPLANT SCIENCES CORP. 510(k) NO: K070468(SPECIAL)
ATTN: MATTHEW HOLLOWS PHONE NO : 781-246-0700 107 AUDUBON ROAD, #5 SE DECISION MADE: 23-MAR-07 WAKEFIELD, MA 01880-1246 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: URINE CHEMISTRY ANALYZER UR-50 IND DIAGNOSTIC INC. 510(k) NO: K063390(TRADITIONAL)
ATTN: BRIAN LEMAY PHONE NO : 321-299-2521 P.O. BOX 162 SE DECISION MADE: 01-MAR-07 ALTAMONTE SPRINGS, FL 32716 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: INNOVACON FLIPCARD FECAL OCCULT BLOOD TEST DEVICE INNOVACON, INC. 510(k) NO: K063673(TRADITIONAL)
ATTN: EDWARD TUNG PHONE NO : 858-535-2030 4106 SORRENTO VALLEY BLVD. SE DECISION MADE: 05-MAR-07 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EARCHECK ACOUSTIC REFLECTOMETER INNOVIA MEDICAL, LLC 510(k) NO: K070312(SPECIAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412 13 RED FOX LANE SE DECISION MADE: 02-MAR-07 LITTLETON, CO 80127 510(k) STATEMENT DEVICE: QUANTA LITE H-TTG/DGP SCREEN INOVA DIAGNOSTICS, INC. 510(k) NO: K070083(TRADITIONAL)
ATTN: BRYS C MYERS PHONE NO : 858-586-9900 9900 OLD GROVE RD. SE DECISION MADE: 12-MAR-07 SAN DIEGO, CA 92131-1638 510(k) STATEMENT DEVICE: HEMOSIL PROCLOT INSTRUMENTATION LABORATORY CO. 510(k) NO: K070635(SPECIAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467 113 HARTWELL AVE. SE DECISION MADE: 29-MAR-07 LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #85 INVERNESS MEDICAL PROFESSIONAL DIA510(k) NO: K070522(SPECIAL)
ATTN: KAREN MORTIMER PHONE NO : 207-730-5705 10 SOUTHGATE RD. SE DECISION MADE: 15-MAR-07 SCARBOROUGH, ME 04074 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IBI INQUIRY CLEARICE INTRACARDIAC ECHOCARDIOGRAPHY ULTRASOUND IM IRVINE BIOMEDICAL,INC.(IBI) 510(k) NO: K070011(TRADITIONAL)
ATTN: ROHIT PATEL PHONE NO : 949-271-1127 2375 MORSE AVE. SE DECISION MADE: 20-MAR-07 IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENESIS DIODE LASER IVOCLAR VIVADENT, INC. 510(k) NO: K062258(TRADITIONAL)
ATTN: DONNA MARIE HARTNETT PHONE NO : 716-691-0010 175 PINEVIEW DRIVE SE DECISION MADE: 21-MAR-07 AMHERST, NY 14228 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CREATION CP-ZI PORCELAIN JENSEN INDUSTRIES, INC. 510(k) NO: K070114(ABBREVIATED)
ATTN: GARY PHELPS PHONE NO : 203-239-2090 50 STILLMAN RD. SE DECISION MADE: 01-MAR-07 NORTH HAVEN, CT 06473 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JOYKEY SURGICAL GOWNS (STERILE) JOYKEY INDUSTRYIAL LTD. 510(k) NO: K062479(TRADITIONAL)
ATTN: JENNIFER REICH PHONE NO : 928-853-6340 2904 N. BOLDT DRIVE SE DECISION MADE: 14-MAR-07 FLAGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JOYKEY SURGICAL DRAPES (STERILE) JOYKEY INDUSTRYIAL LTD. 510(k) NO: K062480(TRADITIONAL)
ATTN: JENNIFER REICH PHONE NO : 928-853-6340 2904 N. BOLDT DRIVE SE DECISION MADE: 05-MAR-07 FLAGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLAQUE SCRAPER-A INTERPROXIMAL (BETWEEN TEETH) PLAQUE REMOVER, M KEVIN VU, DDS 510(k) NO: K070127(TRADITIONAL)
ATTN: GLEN FEYE PHONE NO : 619-517-1762 1340 WEST PENNSYLVANIA AVE. SE DECISION MADE: 29-MAR-07 SAN DIEGO, CA 92103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BP 101 DIGITAL BLOOD PRESSURE MONITOR KING YIELD HONGKONG LIMITED 510(k) NO: K062033(TRADITIONAL)
ATTN: DACHENG GONG PHONE NO : 867 552 7371997 12 FL, NO. 180 ELECTRIC ROAD SE DECISION MADE: 23-MAR-07 NORTH POINT, HONG KONG 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES KIRWAN SURGICAL PRODUCTS, INC. 510(k) NO: K062659(TRADITIONAL)
ATTN: KEVIN P PRARIO PHONE NO : 781-834-6600 180 ENTERPRISE DR. SE DECISION MADE: 09-MAR-07 MARSHFIELD, MA 02050 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KLS MARTIN QUICK DISC, STERNAL TALON AND STERNAL PLATING - STERI KLS MARTIN L.P. 510(k) NO: K070169(TRADITIONAL)
ATTN: JENNIFER DAMATO PHONE NO : 904-641-7746 11239 ST. JOHNS INDUSTRIAL SE DECISION MADE: 26-MAR-07 PARKWAY SOUTH 510(k) SUMMARY AVAILABLE FROM FDA JACKSONVILLE, FL 32246 DEVICE: CLEARFIL MAJESTY ESTHETIC PLT KURARAY MEDICAL INC. 510(k) NO: K070325(TRADITIONAL)
ATTN: KOJI NISHIDA PHONE NO : 212-986-2230 600 LEXINGTON AVENUE SE DECISION MADE: 21-MAR-07 26TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA NEW YORK, NY 10022 DEVICE: SLIM EVOLUTION FAMILY OF CO2 LASERS AND DELIVERY DEVICE ACCESSOR LASERING S.R.L. 510(k) NO: K063001(TRADITIONAL)
ATTN: ALLEN R HOWES PHONE NO : 925-355-0750 2246 CAMINO RAMON SE DECISION MADE: 07-MAR-07 SAN RAMON, CA 94583 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LERADO, POWER WHEELCHAIR, PB LERADO CHINA LIMITED 510(k) NO: K070433(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829 NO. 58, FU-CHIUN ST. SE DECISION MADE: 16-MAR-07 HSIN-CHU CITY, CHINA (TAIWAN) 3006510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LMT-KATH-S; LMT-KATH-I LICHER MEDIZINTECHNOLOGIE GMBH 510(k) NO: K062308(ABBREVIATED)
ATTN: DIETER MUSHOFF PHONE NO : 011 49 51305855 MARDERWEG 1 SE DECISION MADE: 20-MAR-07 WEDEMARK, GERMANY D-30900 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFE SPINE ANTERIOR CERVICAL PLATE SYSTEM LIFE SPINE 510(k) NO: K070285(TRADITIONAL)
ATTN: REBECCA M BROOKS PHONE NO : 847-884-6117 2400 HASSELL ROAD SE DECISION MADE: 13-MAR-07 SUITE 370 510(k) SUMMARY AVAILABLE FROM FDA HOFFMAN ESTATES, IL 60169 DEVICE: LIV BREAST SELF EXAMINATION AID LIV INTERNATIONAL USA, INC. 510(k) NO: K070344(TRADITIONAL)
ATTN: PARTICK GORA PHONE NO : 507-269-2895 5811 PARTRIDGE DRIVE SW SE DECISION MADE: 08-MAR-07 ROCHESTER, MN 55902 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: POWDER FREE NITRILE BLUE EXAMINATION GLOVE LIWE TRADING 510(k) NO: K061504(TRADITIONAL)
ATTN: K M LEE PHONE NO : 033 392 1992 49,JALAN SS 2/19 SE DECISION MADE: 19-MAR-07 47300 PETALING JAYA 510(k) STATEMENT SELANGOR DARUL EHSAN, MALAYSIA 47300 DEVICE: MA 55 "MAESTRO" MAICO DIAGNOSTICS (DIAGNOSTIC GROU510(k) NO: K063452(TRADITIONAL)
ATTN: DANIEL EGGAN PHONE NO : 952-278-4457 7625 GOLDEN TRIANGLE D SE DECISION MADE: 29-MAR-07 EDEN PRAIRIE, MN 55344 510(k) STATEMENT DEVICE: POWERLED SURGICAL LIGHT SYSTEM MAQUET S.A. 510(k) NO: K070442(SPECIAL)
ATTN: KEVIN M TOMPKINS PHONE NO : 585-272-5078 1777 EAST HENRIETTA RD. SE DECISION MADE: 16-MAR-07 ROCHESTER, NY 14623 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GUARDIANCATHETER-URINARY DRAINAGE CATHETER MARIAN MEDICAL, INC. 510(k) NO: K063795(TRADITIONAL)
ATTN: SANDRA WINKLER PHONE NO : 502-552-6189 319 WESTPORT DR. SE DECISION MADE: 05-MAR-07 LOUISVILLE, KY 40207 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT MARIAN MEDICAL, INC. 510(k) NO: K070048(TRADITIONAL)
ATTN: SANDRA WINKLER PHONE NO : 502-552-6189 319 WESTPORT DR. SE DECISION MADE: 15-MAR-07 LOUISVILLE, KY 40207 510(k) STATEMENT DEVICE: SURGI-WRAP MAST TENDON SHEET MAST BIOSURGERY USA INC. 510(k) NO: K063648(TRADITIONAL)
ATTN: KENNETH K KLEINHENZ PHONE NO : 858-458-0900 6749 TOP GUN ST., SUITE C SE DECISION MADE: 07-MAR-07 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAXHEALTH MECHANICAL WHEELCHAIR, K1 MAXHEALTH CORP. 510(k) NO: K070176(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829 NO. 58, FU-CHIUN ST. SE DECISION MADE: 01-MAR-07 HSIN-CHU CITY,, CHINA (TAIWAN) 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS MEDICAL ELECTRONIC SYSTEMS LTD. 510(k) NO: K063864(TRADITIONAL)
ATTN: ERIKA B AMMIRATI PHONE NO : 650-949-2768 575 SHIRLYNN CT. SE DECISION MADE: 26-MAR-07 LOS ALTOS, CA 94022 510(k) STATEMENT DEVICE: ATRILAZE MI SURGICAL ABLATION SYSTEM MEDICALCV, INC. 510(k) NO: K061489(ABBREVIATED)
ATTN: DENNY STEGER PHONE NO : 651-452-3000 9725 SOUTH ROBERT TRAIL SE DECISION MADE: 16-MAR-07 INVER GROVE HEIGHTS, MN 55077 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECONOLITH EM1000 MEDISPEC, LTD. 510(k) NO: K063504(TRADITIONAL)
ATTN: ANIL DHINGRA PHONE NO : 301-944-1575 12850 MIDDLEBROOK RD. STE. 1 SE DECISION MADE: 09-MAR-07 GERMANTOWN, MD 20874 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY MEDRAD, INC. 510(k) NO: K063090(TRADITIONAL)
ATTN: TROY A JACK PHONE NO : 412-767-2400 ONE MEDRAD DR. SE DECISION MADE: 27-MAR-07 INDIANOLA, PA 15051 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BANANA RIBBED MEDTECH PRODUCTS LTD. 510(k) NO: K063401(ABBREVIATED)
ATTN: RAVI REDDY PHONE NO : 425-641-5192 5876 155TH AVE. S.E. SE DECISION MADE: 26-MAR-07 BELLEVUE, WA 98006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NON-CHLORINATED POLYMER COATED POWDER-FREE NATURAL LATEX EXAMINA MEDTEXX MANUFACTURING SDN. BHD. 510(k) NO: K070072(TRADITIONAL)
ATTN: OOI LOON SENG (MDM) PHONE NO : 605 891 1111 PT 4004 KAMUNTING INDU. ESTATE SE DECISION MADE: 15-MAR-07 KAMUNTING, TAIPING, PERAK, MALAYSI510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATTAIN HYBRID GUIDE WIRES, MODEL GWR419378, GWR419388, GWR419478 MEDTRONIC INC., CARDIAC RHYTHM MAN510(k) NO: K063210(TRADITIONAL)
ATTN: MICHELLE NIVALA PHONE NO : 763-505-7263 1015 GRAMSIE RD SE DECISION MADE: 15-MAR-07 SHOREVIEW, MN 55126-3082 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARCUATE VERTEBRAL AUGMENTATION SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K063248(TRADITIONAL)
ATTN: CHRISTINE SCIFERT PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 13-MAR-07 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: T2 SCEPTOR SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K063491(TRADITIONAL)
ATTN: CHRISTINE SEIFERT PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 05-MAR-07 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K070173(SPECIAL)
ATTN: CHRISTINE SCIFERT PHONE NO : 901-396-3133 1800 PYRAMID PL. SE DECISION MADE: 14-MAR-07 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDTRONIC PERFORMER CPB, MODEL R51/PCPB MEDTRONIC, INC. 510(k) NO: K070213(TRADITIONAL)
ATTN: PREETI JAIN PHONE NO : 763-391-9533 7611 NORTHLAND DR. SE DECISION MADE: 21-MAR-07 MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEMOMETAL MEMORY STAPLES MEMOMETAL TECHNOLOGIES 510(k) NO: K070031(TRADITIONAL)
ATTN: GILLES AUDIC PHONE NO : 33 2 99055969 RUE BLAISE PASCAL SE DECISION MADE: 19-MAR-07 CAMPUS DE KER LANN 510(k) SUMMARY AVAILABLE FROM FDA BRUZ, FRANCE F35170 DEVICE: MEMOMETAL VARISATION, MODELS AV26-08, AV26-10, AV90-08 AND AV90- MEMOMETAL TECHNOLOGIES 510(k) NO: K070033(TRADITIONAL)
ATTN: GILLES AUDIC PHONE NO : 33 2 99055969 RUE BLAISE PASCAL SE DECISION MADE: 19-MAR-07 CAMPUS DE KER LANN 510(k) SUMMARY AVAILABLE FROM FDA BRUZ, FRANCE F35170 DEVICE: MEMOMETAL FIXOS SCREWS MEMOMETAL TECHNOLOGIES 510(k) NO: K070039(TRADITIONAL)
ATTN: GILLES AUDIC PHONE NO : 33 2 99055969 RUE BLAISE PASCAL SE DECISION MADE: 21-MAR-07 CAMPUS DE KER LANN 510(k) SUMMARY AVAILABLE FROM FDA BRUZ, FRANCE F35170 DEVICE: SURGICAL FACE MASK, TYPE: TIE-ON, EAR-LOOP MODERN HEALTHCARE CORP. 510(k) NO: K063043(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829 NO. 58, FU-CHIUN ST. SE DECISION MADE: 21-MAR-07 HSIN-CHU CITY, CHINA (TAIWAN) 3006510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MONEBO AUTOMATED ECG ANALYSIS AND INTERPRETATION SOFTWARE LIBRAR MONEBO TECHNOLOGIES, INC. 510(k) NO: K062282(TRADITIONAL)
ATTN: DALE J MISCZYNSKI PHONE NO : 512-732-0235 1800 BARTON CREEK BLVD. SE DECISION MADE: 22-MAR-07 AUSTIN, TX 78735-1606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDIOBELT ELECTRODE BELT MONEBO TECHNOLOGIES, INC. 510(k) NO: K063044(ABBREVIATED)
ATTN: DALE J MISCZYNSKI PHONE NO : 512-732-0235 1800 BARTON CREEK BLVD. SE DECISION MADE: 23-MAR-07 AUSTIN, TX 78735-1606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MOORLD12-B1 LASER DOPPLER BURNS IMAGER MOOR INSTRUMENTS LTD. 510(k) NO: K060976(TRADITIONAL)
ATTN: DAVID BOGGETT PHONE NO : 441 297 35715 MILLWEY SE DECISION MADE: 27-MAR-07 AXMINSTER, DEVON, UNITED KINGDOM E510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MORTARA ELI 10 ELECTROCARDIOGRAPH MORTARA INSTRUMENT, INC. 510(k) NO: K070539(SPECIAL)
ATTN: LAURA M SPIEGELHOFF PHONE NO : 414-354-1600 7865 NORTH 86TH ST. SE DECISION MADE: 15-MAR-07 MILWAUKEE, WI 53224 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DBX DEMINERALIZED BONE MATRIX MIX MUSCULOSKELETAL TRANSPLANT FOUNDAT510(k) NO: K063676(TRADITIONAL)
ATTN: NANCY BENNEWITZ PHONE NO : 732-661-0202 125 MAY ST, STE 300 SE DECISION MADE: 05-MAR-07 EDISON CORP CTR 510(k) SUMMARY AVAILABLE FROM FDA EDISON, NJ 08837 DEVICE: D-CARIE/DETECTAR, MODELS N121, N123, N133, N134, N135 & N138 NEKS TECHNOLOGIES, INC. 510(k) NO: K063321(TRADITIONAL)
ATTN: NAIM KARAZIVAN PHONE NO : 450 973 3598 2816, JOSEPH A. BOMBARDIER SE DECISION MADE: 30-MAR-07 LAVAL, QUEBEC, CANADA H7P 6E2 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MOD NEO-GENESIS 510(k) NO: K060452(ABBREVIATED)
ATTN: JANNET BALDWIN PHONE NO : 503-255-3002 4814 N.E. 107TH AVENUE SE DECISION MADE: 13-MAR-07 PORTLAND, OR 97220 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEWDEAL COMPRESSION PLATE NEWDEAL SAS 510(k) NO: K070447(TRADITIONAL)
ATTN: JUDITH E O'GRADY PHONE NO : 609-936-2311 311 ENTERPRISE DR. SE DECISION MADE: 29-MAR-07 PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIRCONIA IMPLANT NOBEL BIOCARE AB 510(k) NO: K061971(TRADITIONAL)
ATTN: HERBERT CRANE PHONE NO : 714-282-5074 22715 SAVI RANCH PARKWAY SE DECISION MADE: 06-MAR-07 YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OLYMPUS TRIGLYCERIDE TEST SYSTEM OLYMPUS AMERICA, INC. 510(k) NO: K063804(TRADITIONAL)
ATTN: BEV HARDING PHONE NO : 972-619-4710 3131 WEST ROYAL LN. SE DECISION MADE: 23-MAR-07 IRVING, TX 75063-3104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOSCOPIC INSUFFLATION UNIT, MODEL XECR-2 OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K063786(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 484-896-5688 3500 CORPORATE PARKWAY SE DECISION MADE: 05-MAR-07 PO BOX 610 510(k) SUMMARY AVAILABLE FROM FDA CENTER VALLEY, PA 18034-0610 DEVICE: ORISON EMBRACE SYSTEM ORISON CORPORATION 510(k) NO: K070477(TRADITIONAL)
ATTN: JOHN DIXON PHONE NO : 423-946-0629 121 BOONE RIDGE DR. SE DECISION MADE: 09-MAR-07 JOHNSON CITY, TN 37601 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: OSTEOMED HEADLESS CANNULATED SCREW SYSTEM OSTEOMED L.P. 510(k) NO: K063298(TRADITIONAL)
ATTN: DAWN D TINDALL PHONE NO : 972-677-4600 3885 ARAPAHO RD. SE DECISION MADE: 02-MAR-07 ADDISON, TX 75001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTEOMED EXTERNAL MANDIBULAR DISTRACTION SYSTEM OSTEOMED L.P. 510(k) NO: K063792(TRADITIONAL)
ATTN: PIEDAD PENA PHONE NO : 972-677-4600 3885 ARAPAHO RD. SE DECISION MADE: 02-MAR-07 ADDISON, TX 75001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC OXOID, LTD. 510(k) NO: K070262(TRADITIONAL)
ATTN: ANDY HOLLINGSWORTH PHONE NO : 44 125 6841144 WADE RD. SE DECISION MADE: 14-MAR-07 BASINGSTOKE, HANTS, UNITED KINGDOM510(k) STATEMENT DEVICE: P&F POWER WHEELCHAIR, HC-510 P&F BROTHER IND.,CORP 510(k) NO: K070350(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 352 08829 NO.58, FU-CHIUN ST. SE DECISION MADE: 14-MAR-07 HSIN-CHU CITY, CHINA (TAIWAN) 3006510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TROKABONE, TROKABONE STERNAL PAJUNK GMBH MEDIZINTECHNOLOGIE 510(k) NO: K070179(TRADITIONAL)
ATTN: CHRISTIAN QUASS PHONE NO : 049 770 49291586 KARL-HALL-STRASSE 1 SE DECISION MADE: 07-MAR-07 GEISINGEN, BADEN-WURTTEMBERG, GERM510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXPRESSWAY INTERMITTENT CATHETER PERCUTANEOUS SYSTEMS, INCORPORATED510(k) NO: K061766(TRADITIONAL)
ATTN: THOMAS LAWSON PHONE NO : 650-969-8800 1300 CRITTENDEN LANE SE DECISION MADE: 09-MAR-07 SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA MOUNTAIN VIEW, CA 94043 DEVICE: K-Y BRAND WARMING LIQUID PERSONAL PRODUCTS CO. 510(k) NO: K070545(SPECIAL)
ATTN: NADER FOTOUHI PHONE NO : 908-904-3730 199 GRANDVIEW RD. SE DECISION MADE: 23-MAR-07 SKILLMAN, NJ 08558 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELIA GLIADIN IGA, IGG AND CELIAC CONTROL PHADIA US INC. 510(k) NO: K063775(TRADITIONAL)
ATTN: MARTIN R MANN PHONE NO : 269-492-1957 4169 COMMERCIAL AVE. SE DECISION MADE: 14-MAR-07 PORTAGE, MI 49002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHILIPS SURESIGNS VSV (VITAL SIGNS VIEWER) PHILIPS MEDICAL SYSTEMS 510(k) NO: K070588(SPECIAL)
ATTN: TAPAN D SHAH PHONE NO : 978-659-7681 3000 MINUTEMAN RD. SE DECISION MADE: 20-MAR-07 ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHILIPS ESSENTA DR PHILIPS MEDICAL SYSTEMS GMBH, DMC 510(k) NO: K070528(TRADITIONAL)
ATTN: LYNN HARMER PHONE NO : 425-487-7312 22100 BOTHELL EVERETT HIGHWAY SE DECISION MADE: 09-MAR-07 BOTHELL, WA 98041-3003 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PS SERIES PHOTONIC OPTISCHE GERATE GESMBH & 510(k) NO: K061622(TRADITIONAL)
ATTN: DIETER FEGER PHONE NO : 43 1 4865691 SEEBOCKGASSE 59 SE DECISION MADE: 05-MAR-07 VIENNA, AUSTRIA A-1160 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MODIFICATION TO: PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYST PIONEER SURGICAL TECHNOLOGY 510(k) NO: K070551(SPECIAL)
ATTN: JONATHAN M GILBERT PHONE NO : 906-226-4812 375 RIVER PARK CIRCLE SE DECISION MADE: 29-MAR-07 MARQUETTE, MI 49855-0627 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROMOS MODULAR SHOULDER SYSTEM PLUS ORTHOPEDICS AG 510(k) NO: K063578(TRADITIONAL)
ATTN: PAMELA J WEAGRAFF PHONE NO : 508-528-1745 18 BRIDIE LANE SE DECISION MADE: 02-MAR-07 NORFOLK, MA 02056 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERIPATCH ENDO-SLEEVE PM DEVICES, INC. 510(k) NO: K063556(TRADITIONAL)
ATTN: TIM VERSPAGEN PHONE NO : 604 270 4344 13700 MAYFIELD PL. SE DECISION MADE: 20-MAR-07 UNIT 2135 510(k) STATEMENT RICHMOND, CANADA V6V 2E4 DEVICE: APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS POINTE SCIENTIFIC, INC. 510(k) NO: K061377(TRADITIONAL)
ATTN: WILLIAM WALTERS PHONE NO : 734-487-8310 5449 RESEARCH DRIVE SE DECISION MADE: 28-MAR-07 CANTON, MI 48188 510(k) STATEMENT DEVICE: SENSTOUCH HIGH RISK BLUE LATEX EXAMINATION GLOVES, POWDERED, NON PT MAHAKARYA INTI BUANA 510(k) NO: K063581(TRADITIONAL)
ATTN: V. NADARAJAN PHONE NO : 62 61 7944880 JL.SEI BELUMAI DESA DALU 10A SE DECISION MADE: 15-MAR-07 DUSUN I 510(k) STATEMENT TANJUNG MORAWA, SUMUT, INDONESIA 20362 DEVICE: R&D SICKLE QC CONTROL R & D SYSTEMS, INC. 510(k) NO: K070334(TRADITIONAL)
ATTN: RALPH E HOGANCAMP PHONE NO : 612-656-4413 614 MCKINLEY PL., N.E. SE DECISION MADE: 29-MAR-07 MINNEAPOLIS, MN 55413 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLASMACON N, PLASMACON L-1, PLASMACON L-2 R2 DIAGNOSTICS, INC. 510(k) NO: K062306(TRADITIONAL)
ATTN: MARC GOLDFORD PHONE NO : 574-288-4377 1801 COMMERCE DR. SE DECISION MADE: 16-MAR-07 SOUTH BEND, IN 46628 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRE-LOADED VISICOIL RADIOMED CORPORATION 510(k) NO: K070305(SPECIAL)
ATTN: GORDON ROBERTS PHONE NO : 978-649-0300 ONE INDUSTRIAL WAY SE DECISION MADE: 07-MAR-07 TYNGSBORO, MA 01879-1400 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROCHEM EXT CHEMICAL INTEGRATOR RAVEN BIOLOGICAL LABORATORIES, INC510(k) NO: K062651(TRADITIONAL)
ATTN: WENDY ROYALTY-HANN PHONE NO : 402-593-0781 8607 PARK DR. SE DECISION MADE: 15-MAR-07 OMAHA, NE 68127 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: OCU-FILM TIP COVER REICHERT, INC. 510(k) NO: K070534(SPECIAL)
ATTN: SANDRA BROWN PHONE NO : 716-686-4599 3362 WALDEN AVE. SE DECISION MADE: 27-MAR-07 DEPEW, NY 14043 510(k) STATEMENT DEVICE: SATURN 3 LASER SYSTEM RESEARCH INSTRUMENTS LTD. 510(k) NO: K060764(TRADITIONAL)
ATTN: GRACE HOLLAND PHONE NO : 949-262-0411 3722 AVE. SAUSALITO SE DECISION MADE: 12-MAR-07 IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REMSTAR AFLEX CPAP SYSTEM RESPIRONICS INC., SLEEP & HOME RES510(k) NO: K063830(SPECIAL)
ATTN: ZITA A YURKO PHONE NO : 724-387-4120 1001 MURRY RIDGE LN. SE DECISION MADE: 09-MAR-07 MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RETRO-TECH DRESSING RETRO-TECH, LLC 510(k) NO: K060832(TRADITIONAL)
ATTN: GRACE HOLLAND PHONE NO : 949-262-0411 3722 AVE. SAUSALITO SE DECISION MADE: 13-MAR-07 IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENGIGEL MOUTHRINSE RICERFARMA SRL 510(k) NO: K053342(TRADITIONAL)
ATTN: PAUL KETTERIDGE PHONE NO : 410-788-5492 303 PATLEIGH ROAD SE DECISION MADE: 13-MAR-07 CATONSVILLE, MD 21228 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TINA-QUANT D-DIMER TEST SYSTEM ROCHE DIAGNOSTICS CORP. 510(k) NO: K062203(TRADITIONAL)
ATTN: THERESA AMBROSE BUSH PHONE NO : 317-521-3723 9115 HAGUE RD. SE DECISION MADE: 14-MAR-07 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TDM CONTROL SET, MODEL CAT# 04521536 ROCHE DIAGNOSTICS CORP. 510(k) NO: K070200(SPECIAL)
ATTN: DIMITRIS DEMIRTZOGLOU PHONE NO : 317-521-7688 9115 HAGUE RD. SE DECISION MADE: 19-MAR-07 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECSYS PTH TEST SYSTEM ROCHE DIAGNOSTICS CORP. 510(k) NO: K070391(SPECIAL)
ATTN: KAY TAYLOR PHONE NO : 317-521-3544 9115 HAGUE RD. SE DECISION MADE: 20-MAR-07 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLEXIBLE LOOP ELECTROSURGICAL ELECTRODE RUBICOR MEDICAL, INC. 510(k) NO: K070275(TRADITIONAL)
ATTN: HUGH MAGEN PHONE NO : 650-556-1070 600 CHESAPEAKE DRIVE SE DECISION MADE: 09-MAR-07 REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SAF-T-SYRINGE- 0.5 AND 1ML/CC SAFETY MEDICAL INTERNATIONAL, INCO510(k) NO: K063340(TRADITIONAL)
ATTN: FRAN WHITE PHONE NO : 978-927-3808 163 CABOT ST. SE DECISION MADE: 06-MAR-07 BEVERLY, MA 01915 510(k) STATEMENT DEVICE: BP-200 PLUS SCHILLER AG 510(k) NO: K063814(TRADITIONAL)
ATTN: RETO KUETTEL PHONE NO : 41 417 664343 ALTGASSE 68 SE DECISION MADE: 07-MAR-07 BAAR, ZG, SWITZERLAND 6341 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLEXILUX II CYSTOSCOPE AND HYSTEROSCOPE SCHOELLY IMAGING, INC. 510(k) NO: K060899(TRADITIONAL)
ATTN: BONI S BONNEVILLE PHONE NO : 508-425-6989 173 GROVE STREET SE DECISION MADE: 02-MAR-07 WORCESTER, MA 01605 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: LIGAFIX INTERFERENCE SCREW SCIENCE FOR BIOMATERIALS 510(k) NO: K070507(SPECIAL)
ATTN: DENIS CLEMENT PHONE NO : 335 624 22101 ZI DU MONGE SE DECISION MADE: 29-MAR-07 LOURDES, FRANCE 65100 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RUIKE 3421 POWERED WHEELCHAIR SHANGHAI RUIKE SPORTS GOODS CO., L510(k) NO: K070501(TRADITIONAL)
ATTN: JUNNATA CHANG PHONE NO : 886 422 465396 14F-2, NO.1, LANE 25 SE DECISION MADE: 22-MAR-07 ZHUANGJING RD. 510(k) SUMMARY AVAILABLE FROM FDA BANQIAO, TAIPEI COUNTY, CHINA (TAIWAN) 220 DEVICE: TEXTURED POWDER FREE NITRILE EXAM GLOVES (PEACH) SHEN WEI (USA), INC. 510(k) NO: K062919(TRADITIONAL)
ATTN: CYNTHIA LIU PHONE NO : 510-429-8692 33278 CENTRAL AVE., SE DECISION MADE: 20-MAR-07 SUITE 102 510(k) STATEMENT UNION CITY, CA 94587 DEVICE: DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K070526(SPECIAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 949-429-5825 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 23-MAR-07 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG LIANHE SHUNDA PLASTIC510(k) NO: K070026(TRADITIONAL)
ATTN: KATHY LIU PHONE NO : 909-591-7888 3973 SCHAEFER AVE SE DECISION MADE: 07-MAR-07 CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDERED (WHITE) VINYL PATIENT EXAMINATION SHIJIAZHUANG LIANHE SHUNDA PLASTIC510(k) NO: K070027(TRADITIONAL)
ATTN: KATHY LIU PHONE NO : 909-591-7888 3973 SCHAEFER AVE SE DECISION MADE: 22-MAR-07 CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDERED FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG LIANHE SHUNDA PLASTIC510(k) NO: K070041(TRADITIONAL)
ATTN: KATHY LIU PHONE NO : 909-591-7888 3973 SCHAEFER AVE SE DECISION MADE: 28-MAR-07 CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDIOCT SHINA SYSTEMS LTD. 510(k) NO: K070226(TRADITIONAL)
ATTN: ELI M ORBACH PHONE NO : 972 299 32768 POB 6718 SE DECISION MADE: 09-MAR-07 EFRAT, ISRAEL 90435 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLEX AND LOOP COIL SET 1.5 T SIEMENS MEDICAL SOLUTIONS 510(k) NO: K070629(TRADITIONAL)
ATTN: HELMUT NEUMANN PHONE NO : 499 131 847445 HENKESTRASSE 127 SE DECISION MADE: 26-MAR-07 ERLANGEN, GERMANY D91052 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ACUSON X150 ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K070576(SPECIAL)
ATTN: SHEILA W PICKERING PHONE NO : 650-943-7187 1230 SHOREBIRD WAY SE DECISION MADE: 26-MAR-07 P O BOX 7393 510(k) SUMMARY AVAILABLE FROM FDA MOUNTAIN VIEW, CA 94039-7393 DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMO SMART GLOVE CORP. SDN BHD 510(k) NO: K063627(TRADITIONAL)
ATTN: CHO S FONG PHONE NO : 603 329 16100 LOT 6487 BATU 5 3/4 SE DECISION MADE: 20-MAR-07 JALAN KAPAR 510(k) SUMMARY AVAILABLE FROM FDA KLANG SELANGOR, MALAYSIA 42100 DEVICE: PLC SUTURE ANCHOR SMITH & NEPHEW INC., ENDOSCOPY DIV510(k) NO: K063726(TRADITIONAL)
ATTN: DEANA BOUSHELL PHONE NO : 508-337-4036 150 MINUTEMAN RD. SE DECISION MADE: 06-MAR-07 ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SECURE ARTERIAL BLOOD SAMPLING SYSTEM SMITHS MEDICAL ASD, INC. 510(k) NO: K070340(TRADITIONAL)
ATTN: BARBARA LAW PHONE NO : 614-791-5568 6250 SHIER RINGS RD. SE DECISION MADE: 15-MAR-07 DUBLIN, OH 40316 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGORA PCT/DIGIPOD SOREDEX PALODEX GROUP OY 510(k) NO: K070304(TRADITIONAL)
ATTN: KAI LANER PHONE NO : 358 45 78822000 NAHKELANTIE 160 SE DECISION MADE: 27-MAR-07 TUUSULA, FINLAND FIN-04300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810 SPACELABS MEDICAL INC. 510(k) NO: K063490(TRADITIONAL)
ATTN: DAVID J GERAGHTY PHONE NO : 425-657-7200 5150 220TH AVE SE SE DECISION MADE: 15-MAR-07 ISSAQUAH, WA 98029 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED HEART STABILIZERS AND POSITIONERS STERILMED, INC. 510(k) NO: K063844(TRADITIONAL)
ATTN: DENNIS TOUSSAINT PHONE NO : 888-856-4870 11140 73RD AVE. NORTH SE DECISION MADE: 15-MAR-07 MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO STIMUPLEX HNS-12, MODEL 4892098 STOCKERT GMBH 510(k) NO: K070134(SPECIAL)
ATTN: DOMINIKA SCHULER PHONE NO : 49 761 207160 BOETZINGER STRASSE 72 SE DECISION MADE: 22-MAR-07 FREIBURG, B-W, GERMANY D-79111 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRYKER T6 HOODS AND TOGAS STRYKER INSTRUMENTS 510(k) NO: K063005(TRADITIONAL)
ATTN: PAULETTE D JOHNSON PHONE NO : 269-323-7700 4100 EAST MILHAM AVE. SE DECISION MADE: 23-MAR-07 KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DALL-MILES SYSTEM STRYKER ORTHOPAEDICS 510(k) NO: K070170(TRADITIONAL)
ATTN: PATRICIA SETTI-LAPERCH PHONE NO : 201-831-5938 325 CORPORATE DRIVE SE DECISION MADE: 02-MAR-07 MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZERO PROFILE ANTERIOR CERVICAL PLATE (ACP) SYSTEM STRYKER SPINE 510(k) NO: K063430(SPECIAL)
ATTN: SIMONA VOIC PHONE NO : 201-760-8145 2 PEARL COURT SE DECISION MADE: 22-MAR-07 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVE, YELLOW SUPER SAFE PLASTIC PRODUCTS CO., L510(k) NO: K070038(TRADITIONAL)
ATTN: KATHY LIU PHONE NO : 909-591-7888 3973 SCHAEFER AVE SE DECISION MADE: 23-MAR-07 CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: YELLOPORT PORT ACCESS SYSTEM SURGICAL INNOVATIONS GROUP PLC 510(k) NO: K070712(SPECIAL)
ATTN: STUART MORAN PHONE NO : 440 113 2307597 CLAYTON PARK CLAYTON WOOD RISE SE DECISION MADE: 28-MAR-07 LEEDS, UNITED KINGDOM LS16,6RF 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SURGIQUEST ELASTOMERIC OPTICAL TROCAR & CANNULA SURGIQUEST, INC. 510(k) NO: K063859(TRADITIONAL)
ATTN: KOUROSH AZARBARZIN PHONE NO : 203-799-2400 12 CASCADE BLVD. SE DECISION MADE: 14-MAR-07 SUITE 2B 510(k) SUMMARY AVAILABLE FROM FDA ORANGE, CT 06477 DEVICE: WILLSON ONE-FIT HEALTHCARE PARTICLE RESPIRATOR AND SURGICAL MASK SURVIVAIR, INC. 510(k) NO: K070139(ABBREVIATED)
ATTN: RICHARD O WOOD PHONE NO : 847-234-7500 1025 W.EVERETT RD. SE DECISION MADE: 02-MAR-07 LAKE FOREST, IL 60045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HWATO TDP HEAT LAMP, MODELS TDP11-DL, TDP12-XL AND TDP-22XL SUZHOU MEDICAL APPLIANCE FACTORY 510(k) NO: K063568(TRADITIONAL)
ATTN: HENRY WOO PHONE NO : 714-545-3181 1491 BAKER ST. SE DECISION MADE: 22-MAR-07 SUITE 1 510(k) SUMMARY AVAILABLE FROM FDA COSTA MESA, CA 92626 DEVICE: SYNTERMED LIVE SYNTERMED, INC. 510(k) NO: K070089(TRADITIONAL)
ATTN: KENNETH F VAN TRAIN PHONE NO : 714-281-1256 245 OWENS DR. SE DECISION MADE: 02-MAR-07 ANAHEIM, CA 92808 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM SYNTHES (USA) 510(k) NO: K062872(TRADITIONAL)
ATTN: DEBORAH L JACKSON PHONE NO : 610-719-6948 1301 GOSHEN PKWY SE DECISION MADE: 13-MAR-07 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM SYNTHES (USA) 510(k) NO: K063473(TRADITIONAL)
ATTN: DEBORAH L JACKSON PHONE NO : 610-719-6948 1301 GOSHEN PKWY SE DECISION MADE: 08-MAR-07 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES (USA) ELBOW HINGE FIXATOR SYNTHES (USA) 510(k) NO: K063832(TRADITIONAL)
ATTN: JENNIFER PERKS PHONE NO : 610-719-6941 1301 GOSHEN PKWY SE DECISION MADE: 07-MAR-07 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES 4.5 MM LCP POSTEROLATERAL PROXIMAL FEMUR PLATES SYNTHES (USA) 510(k) NO: K070208(TRADITIONAL)
ATTN: SHERI L MUSGNUNG PHONE NO : 610-719-6940 1301 GOSHEN PKWY SE DECISION MADE: 28-MAR-07 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES TROCHANTERIC FIXATION NAIL (TFN) SYSTEM, ADDITIONAL HELI SYNTHES (USA) 510(k) NO: K070294(SPECIAL)
ATTN: SHERI L MUSGNUNG PHONE NO : 610-719-6940 1301 GOSHEN PKWY. SE DECISION MADE: 01-MAR-07 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHODONTIC TAADS (TEMPORARY ANATOMICAL ANCHOR DEVICE SYSTEM) T.O.A.D.S., LLC. 510(k) NO: K063149(TRADITIONAL)
ATTN: DAVID BAUGHMAN PHONE NO : 502-581-8770 1226 ROWAN ST. SE DECISION MADE: 08-MAR-07 LOUISVILLE, KY 40203 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEVER CHEK TD-4230 BLOOD GLUCOSE MONITORING SYSTEM, RD-4230, SU TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K070472(SPECIAL)
ATTN: ERICA LI PHONE NO : 886 266 358080 4F, 88, SEC.1, KWANG FU ROAD SE DECISION MADE: 15-MAR-07 SAN CHUNG, TAIPEI, CHINA (TAIWAN) 510(k) STATEMENT DEVICE: ELLEX SLIT LAMP, MODEL 30XL TAKAGI SEIKO CO., LTD. 510(k) NO: K063352(TRADITIONAL)
ATTN: KEVIN HOWARD PHONE NO : 61 8 81045226 82 GILBERT STREET SE DECISION MADE: 13-MAR-07 ADELAIDE, SOUTH AUSTRALIA, AUSTRAL510(k) STATEMENT DEVICE: OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM TAKIRON CO., LTD 510(k) NO: K061881(TRADITIONAL)
ATTN: KUNIHIRO HATA PHONE NO : 81 6 62672809 405 NAGANO, YASUTOMI-CHO SE DECISION MADE: 14-MAR-07 HIMEJI, JAPAN 671-2421 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NITRILE POWDER FREE PATIENT EXAMINATION GLOVES TANGSHAN LUXIONG PLASTIC PRODUCTS 510(k) NO: K070404(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441 NO. 209 BEI SI HUAN ZHONG ROAD SE DECISION MADE: 26-MAR-07 HAIDIAN DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA BEIJING, CHINA 100083 DEVICE: SEKURIT SHARPS COLLECTION CONTAINER TECHEN SAFETY, INC. 510(k) NO: K063722(TRADITIONAL)
ATTN: SID MATHUR PHONE NO : 516-482-9001 55 NORTHERN BLVD SE DECISION MADE: 05-MAR-07 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA GREAT NECK, NY 11021 THIRD PARTY REVIEW DEVICE: TENDERFLOW PERIATRIC ARTERIAL CANNULA TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K063618(SPECIAL)
ATTN: CHRISTINA L THOMAS PHONE NO : 800-262-3304 6200 JACKSON RD. SE DECISION MADE: 13-MAR-07 ANN ARBOR, MI 48103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TR BAND TERUMO MEDICAL CORP. 510(k) NO: K070423(TRADITIONAL)
ATTN: MARK UNTERREINER PHONE NO : 410-392-7213 950 ELKTON BLVD. SE DECISION MADE: 28-MAR-07 ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401 THERMO ELECTRON CORP. 510(k) NO: K061412(TRADITIONAL)
ATTN: BOLA NICHOLSON PHONE NO : 412-747-4039 171 INDUSTRY DRIVE SE DECISION MADE: 23-MAR-07 PITTSBURG, PA 15272 510(k) STATEMENT DEVICE: COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL THERMO ELECTRON OY 510(k) NO: K063150(TRADITIONAL)
ATTN: PAIVI SORMUNEN PHONE NO : 358 9 329100 RATASTIE 2 SE DECISION MADE: 19-MAR-07 PO BOX 100 510(k) SUMMARY AVAILABLE FROM FDA VANTAA, FINLAND FIN-01621 DEVICE: HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL THERMO ELECTRON OY 510(k) NO: K063209(TRADITIONAL)
ATTN: PAIVI SORMUNEN PHONE NO : 358 932 9100 RATASTIE 2 SE DECISION MADE: 21-MAR-07 VANTAA, FINLAND 01620 510(k) STATEMENT DEVICE: CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH THERMO ELECTRON OY 510(k) NO: K063647(TRADITIONAL)
ATTN: PAIVI SORMUNEN PHONE NO : 358 9 32910762 RATASTIE 2 SE DECISION MADE: 12-MAR-07 PO BOX 100 510(k) SUMMARY AVAILABLE FROM FDA VANTAA, FINLAND FIN-01621 DEVICE: OXALATE URINE CONTROLS (NORMAL AND ELEVATED) THERMO-ELECTRON CORP. 510(k) NO: K062521(TRADITIONAL)
ATTN: MELITA LAMBIRIS PHONE NO : 613 979 04100 189-199 BROWNS RD. SE DECISION MADE: 16-MAR-07 NOBLE PARK, VICTORIA, AUSTRALIA 31510(k) STATEMENT DEVICE: PORTI 7 PHYSIOLOGICAL AMPLIFIER TMS INTERNATIONAL BV 510(k) NO: K063599(SPECIAL)
ATTN: DAVID W WAGNER PHONE NO : 303-674-3070 7744 SWAPS TRAIL SE DECISION MADE: 22-MAR-07 EVERGREEN, CO 80439 510(k) STATEMENT DEVICE: TOKUYAMA BOND FORCE TOKUYAMA DENTAL CORPORATION 510(k) NO: K070215(TRADITIONAL)
ATTN: ROBERT A SILVERMAN PHONE NO : 202-783-5070 1425 K STREET, N.W. SUITE 1100 SE DECISION MADE: 30-MAR-07 WASHINGTON, DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 21.3 INCH (54CM) MONOCHROME LCD MONITOR MDL2122A TOTOKU ELECTRIC CO., LTD 510(k) NO: K070370(TRADITIONAL)
ATTN: MIKIO HASEGAWA PHONE NO : 812 683 45469 300 OYA SE DECISION MADE: 09-MAR-07 UEDA, NAGANO, JAPAN 386-0192 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OTOGRAM, CA3350 TYMPANY, INC. 510(k) NO: K070118(TRADITIONAL)
ATTN: LEX J PEARCE PHONE NO : 801-365-2800 2795 EAST COTTONWOOD PKWY. SE DECISION MADE: 07-MAR-07 SUITE 660 510(k) SUMMARY AVAILABLE FROM FDA SALT LAKE CITY, UT 84121 DEVICE: UNITIP HIGH RESOLUTION CATHETER UNISENSOR AG 510(k) NO: K062222(TRADITIONAL)
ATTN: ROBERT N CLARK PHONE NO : 303-234-9412 13605 WEST 7TH AVE. SE DECISION MADE: 15-MAR-07 GOLDEN, CO 80401-4604 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138 UNITED STATES ENDOSCOPY GROUP, INC510(k) NO: K070420(TRADITIONAL)
ATTN: MICHAEL WOLF PHONE NO : 440-639-4494 5976 HEISELY RD. SE DECISION MADE: 19-MAR-07 MENTOR, OH 44060 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: FORCETRIAD ELECTROSURGICAL GENERATOR; LIGASURE INSTRUMENTS VALLEYLAB,A DIVISION OF TYCO HEALT510(k) NO: K070162(TRADITIONAL)
ATTN: PHILIP E AKE PHONE NO : 303-530-6469 5920 LONGBOW DR. SE DECISION MADE: 06-MAR-07 BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VARIAN ESOPHAGUS BOUGIE APPLICATOR VARIAN MEDICAL SYSTEMS 510(k) NO: K063815(TRADITIONAL)
ATTN: VY TRAN PHONE NO : 650-424-5731 3100 HANSEN WAY SE DECISION MADE: 01-MAR-07 M/S E-110 510(k) SUMMARY AVAILABLE FROM FDA PALO ALTO, CA 94304-1129 DEVICE: VARI-LASE BRIGHT TIP FIBER VASCULAR SOLUTIONS, INC. 510(k) NO: K070216(TRADITIONAL)
ATTN: DEBORAH L NEYMARK PHONE NO : 763-656-4349 6464 SYCAMORE COURT SE DECISION MADE: 16-MAR-07 MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VELOCITYAIS VELOCITY MEDICAL SOLUTIONS, LLC 510(k) NO: K070248(TRADITIONAL)
ATTN: PAUL SUMNER PHONE NO : 770-448-7529 1733 CANTON LANE SE DECISION MADE: 01-MAR-07 MARIETTA, GA 30062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIDAR VISION 2000 VIDAR SYSTEMS CORP. 510(k) NO: K070563(TRADITIONAL)
ATTN: JAMES M TAYLOR PHONE NO : 802-244-5654 75 ORCHARD SPRING ESTS. SE DECISION MADE: 16-MAR-07 WATERBURY, VT 05676 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: MET-HEAD MODEL# MHDD-XX:CC DIAMETER, CC CANNULATION VILEX, INC. 510(k) NO: K070052(TRADITIONAL)
ATTN: ABRAHAM LAVI PHONE NO : 412-655-7550 345 OLD CURRY HOLLOW RD. SE DECISION MADE: 28-MAR-07 PITTSBURGH, PA 15236 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX VOLCANO CORPORATION 510(k) NO: K070487(SPECIAL)
ATTN: CYNTHIA VAN DUKER PHONE NO : 916-231-4510 2870 KILGORE RD. SE DECISION MADE: 16-MAR-07 RANCHO CORDOVA, CA 95670 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LINK TO ACUITY CLINICIAN NOTIFIER WELCH ALLYN PROTOCOL, INC. 510(k) NO: K070204(SPECIAL)
ATTN: JEFFREY WAGNER PHONE NO : 503-530-7500 8500 S.W. CREEKSIDE PLACE SE DECISION MADE: 23-MAR-07 BEAVERTON, OR 97008-7107 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BRACHYSCIENCES STRANDPORT WORLDWIDE MEDICAL TECHNOLOGIES, LL510(k) NO: K062214(TRADITIONAL)
ATTN: WAYNE W RICHARDSON PHONE NO : 203-262-4190 115 HURLEY ROAD BLDG. 3B SE DECISION MADE: 01-MAR-07 OXFORD, CT 06478 510(k) STATEMENT DEVICE: ADVANCE SPIKED POROUS TIBIAL BASE WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K063128(TRADITIONAL)
ATTN: THERESA LEISTER PHONE NO : 901-867-4143 5677 AIRLINE RD. SE DECISION MADE: 21-MAR-07 ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVANCE STATURE FEMORAL COMPONENT WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K063731(SPECIAL)
ATTN: THERESA LEISTER PHONE NO : 901-867-4143 5677 AIRLINE RD. SE DECISION MADE: 02-MAR-07 ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHARLOTTE 7.0 MULTI-USE COMPRESSION SCREW AND WASHER WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K070525(SPECIAL)
ATTN: WESLEY L REED PHONE NO : 847-367-1911 5677 AIRLINE RD. SE DECISION MADE: 29-MAR-07 ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLEXLENS MULTIFOCAL SOFT CONTACT LENS, (HIOXIFILCON A) AND (HIOX X-CEL CONTACTS 510(k) NO: K070308(TRADITIONAL)
ATTN: KEVIN RANDALL PHONE NO : 303-956-8595 581 WHILES COURT SE DECISION MADE: 12-MAR-07 ERIE, CO 80516-4933 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEM ZEUS SCIENTIFIC, INC. 510(k) NO: K063186(TRADITIONAL)
ATTN: EWA NADOLCZAK PHONE NO : 908-243-4924 P.O. BOX 38 SE DECISION MADE: 21-MAR-07 RARITAN, NJ 08869 510(k) STATEMENT DEVICE: GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM ZIMMER, INC. 510(k) NO: K070214(TRADITIONAL)
ATTN: BRANDON HIPSHER PHONE NO : 574-371-8083 P.O. BOX 708 SE DECISION MADE: 16-MAR-07 WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIOSTATION ZIOSOFT, INC. 510(k) NO: K070205(TRADITIONAL)
ATTN: MARC GOODMAN PHONE NO : 714-258-4646 5405 ALTON PARKWAY SE DECISION MADE: 23-MAR-07 SUITE A530 510(k) SUMMARY AVAILABLE FROM FDA IRVINE, CA 92604 TOTAL 510(k)s THIS PERIOD 278 TOTAL WITH SUMMARIES 242 TOTAL WITH STATEMENTS 36
Updated May 15, 2007
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