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Medical Devices
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July 2009 510(k) Clearances
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE) 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD July 2009 DEVICE: RAPID PROGRAMMER, VERSION 3.3.0 ADVANCED NEUROMODULATION SYSTEMS, 510(k) NO: K091993(SPECIAL)
ATTN: MIA M WARE PHONE NO : 972 309 8599 6901 PRESTON ROAD SE DECISION MADE: 31-JUL-09 PLANO TX 75024 510(k) STATEMENT DEVICE: MODIFICATION TO:FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-556 ANDON HEALTH CO.,LTD 510(k) NO: K091500(SPECIAL)
ATTN: LIU YI PHONE NO : 862 260 5261618060 NO 31, CHANGJIANG ROAD NANKAI DISTSE DECISION MADE: 31-JUL-09 TIANJIN CH 300190 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100 AXIS-SHIELD DIAGNOSTICS, LTD. 510(k) NO: K083222(TRADITIONAL)
ATTN: CLAIRE DORA PHONE NO : 440 138 2422000 THE TECHNOLOGY PARK SE DECISION MADE: 31-JUL-09 DUNDEE, SCOTLAND UK DD2 1XA 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD MULTITEST 6-COLOR TBNK REAGENT, MODEL 644611 BD BIOSCIENCES 510(k) NO: K090967(TRADITIONAL)
ATTN: KATY CAMPBELL PHONE NO : 408 518 5066 2350 QUME DR. SE DECISION MADE: 31-JUL-09 SAN JOSE CA 95131 1807 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHESSON LABS LIQUID BANDAGE CHESSON LABORATORY ASSOCIATES, INC510(k) NO: K083913(TRADITIONAL)
ATTN: SCOTT E NEUVILLE PHONE NO : 919 419 4900 3100 TOWER BLVD., SUITE 117 SE DECISION MADE: 31-JUL-09 DURHAM NC 27707 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLUCOMANAGER DATA MANAGEMENT SOFTWARE EPS BIO TECHNOLOGY CORP. 510(k) NO: K091229(TRADITIONAL)
ATTN: Y.C. LEI PHONE NO : 886 3 5752522 2 F,NO.49-2, LANE 2, SEC. 2, GUANGSE DECISION MADE: 31-JUL-09 HSINCHU CITY TW 300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HERO VASCULAR ACCESS DEVICE HEMOSPHERE INC 510(k) NO: K091491(SPECIAL)
ATTN: W. ALLEN PUTNAM PHONE NO : 952 582 6900 6545 CITY WEST PARKWAY SE DECISION MADE: 31-JUL-09 EDEN PRAIRIE MN 55344 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLEXITIME FLOW HERAEUS KULZER, INC. 510(k) NO: K091494(TRADITIONAL)
ATTN: CHERYL ZIMMERMAN PHONE NO : 574 291 0661 300 HERAEUS WAY SE DECISION MADE: 31-JUL-09 SOUTH BEND IN 46614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PASS LP SPINAL SYSTEM MEDICREA TECHNOLOGIES 510(k) NO: K083810(SPECIAL)
ATTN: J.D. WEBB PHONE NO : 512 388 0199 1001 OAKWOOD BLVD. SE DECISION MADE: 31-JUL-09 ROUND ROCK TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MTP DISPOSABLE EQUIPMENT COVERS, KARL STORZ 15" TOUCH SCREEN MTP MEDICAL TECHNICAL PROMOTION GM510(k) NO: K091178(TRADITIONAL)
ATTN: YVONNE FERNANDEZ PHONE NO : 424 218 8226 2151 E. GRAND AVENUE SE DECISION MADE: 31-JUL-09 EL SEGUNDO CA 90245 5017 510(k) STATEMENT DEVICE: SYNTHES (USA) 1.5MM HEADLESS COMPRESSION SCREWS SYNTHES (USA) 510(k) NO: K090949(TRADITIONAL)
ATTN: KARL J NITTINGER PHONE NO : 610 719 6941 1301 GOSHEN PKWY. SE DECISION MADE: 31-JUL-09 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TI-TAMED SPINAL SYSTEM TI-TAMED (PTY) LTD 510(k) NO: K070385(TRADITIONAL)
ATTN: SANDRA MORTIMER PHONE NO : 272 150 8382 54 AUCKLAND STREET PAARDEN EILAND SE DECISION MADE: 31-JUL-09 CAPE TOWN, WESTERN CAPE SF 7405510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL CLAIM WRP ASIA PACIFIC SDN. BHD. 510(k) NO: K083410(TRADITIONAL)
ATTN: KIRK PENNER PHONE NO : 603 870 61486 LOT 1, JALAN 3, KAWASAN PERUSAHAANSE DECISION MADE: 31-JUL-09 SALAK TINGGI, SEPANG SELANGOR M510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WRP ASIA PACIFIC SDN. BHD. 510(k) NO: K083408(TRADITIONAL)
ATTN: KIRK PENNER PHONE NO : 603 870 61486 LOT 1, JALAN 3, KAWASAN PERUSAHAANSE DECISION MADE: 31-JUL-09 SALAK TINGGI, SEPANG SELANGOR M510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOFTLASE PRO, ORTHOLASE AND HYGIENELASE ZAP LASERS, LLC 510(k) NO: K091796(TRADITIONAL)
ATTN: JAY GOBLE PHONE NO : 888 876 4546 2621-B PLEASANT HILL RD. SE DECISION MADE: 31-JUL-09 PLEASANT HILL CA 94523 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SILVER PU ANTIBACTERIAL FOAM DRESSING - NON ADHERENT AND ISLAND ADVANCED MEDICAL SOLUTIONS LIMITED510(k) NO: K091013(TRADITIONAL)
ATTN: CLAIRE RYAN PHONE NO : 44 160 6863500 ROAD THREE WINSFORD INDUSTRIAL ESTSE DECISION MADE: 30-JUL-09 WINSFORD CHESHIRE UK CW7 3PD 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025 1 OZ. (30G TUBE), MODEL A2026 3 OZ (90G TUBE),MODEL A2027 AMERX HEALTH CARE CORP. 510(k) NO: K092086(TRADITIONAL)
ATTN: ART W SIMONETTI, LPN PHONE NO : 727 443 0530 1300 S. HIGHLAND AVE. SE DECISION MADE: 30-JUL-09 CLEARWATER FL 33756 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7962 ANDON HEALTH CO.,LTD 510(k) NO: K091997(SPECIAL)
ATTN: LIU YI PHONE NO : 862 260 5261618060 NO 31, CHANGJIANG ROAD NANKAI DISTSE DECISION MADE: 30-JUL-09 TIANJIN CH 300193 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-738 AND KD-739 ANDON HEALTH CO.,LTD 510(k) NO: K092045(SPECIAL)
ATTN: LIU YI PHONE NO : 86 22 60526161 NO 31, CHANGJIANG ROAD NANKAI DISTSE DECISION MADE: 30-JUL-09 TIANJIN CH 300190 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076-6040, 2092-6040, 2105-6040 ANGIOSCORE, INC. 510(k) NO: K091966(SPECIAL)
ATTN: KIMBERLEY KLINE PHONE NO : 510 933 7989 5055 BRANDIN COURT SE DECISION MADE: 30-JUL-09 FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE GRAFT SUBSTITUTE APATECH LTD. 510(k) NO: K090850(TRADITIONAL)
ATTN: CANDACE F CEDERMAN PHONE NO : 503 722 7494 15058 ARMEL DRIVE SE DECISION MADE: 30-JUL-09 OREGON CITY OR 97045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORDCAP CENTRIX, INC. 510(k) NO: K091380(TRADITIONAL)
ATTN: JOHN DISCKO PHONE NO : 203 567 7426 770 RIVER RD. SE DECISION MADE: 30-JUL-09 SHELTON CT 06484 5458 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFIED CONCENTRIC MICROCATHETER, MODEL 90047 CONCENTRIC MEDICAL, INC. 510(k) NO: K091961(SPECIAL)
ATTN: KIRSTEN VALLEY PHONE NO : 650 810 1707 301 E. EVELYN AVE. SE DECISION MADE: 30-JUL-09 MOUNTAIN VIEW CA 94041 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 5.5 HELICAL FLANGE SPINAL SYSTEM, POLARIS COMPONENTS EBI, L.P. 510(k) NO: K090203(SPECIAL)
ATTN: VIVIAN KELLY PHONE NO : 973 299 9300 100 INTERPACE PKWY. SE DECISION MADE: 30-JUL-09 PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AIRBLOC TRANSSEPTAL INTRODUCER, 53 CM, MODEL FA001, AIRBLOCK TRANSSEPTAL INTRODUCER, 72 CM ,MODEL FA002 EP DYNAMICS, INC. 510(k) NO: K090867(TRADITIONAL)
ATTN: ALBERT REGO PHONE NO : 949 770 8710 27001 LA PAZ #314 SE DECISION MADE: 30-JUL-09 MISSION VIEJO CA 92691 510(k) STATEMENT DEVICE: EXSALT SD7 WOUND DRESSING EXCITON TECHNOLOGIES INC. 510(k) NO: K083870(TRADITIONAL)
ATTN: SANDRA REIS PHONE NO : 905 364 7800 6605 HRONTARIO STREET SE DECISION MADE: 30-JUL-09 MISSISSAUGA, ONTARIO CA L5T O3A510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDOS HILITE RESERVOIR, MODEL: 4030 GISH BIOMEDICAL, INC. 510(k) NO: K083131(TRADITIONAL)
ATTN: JANET PEETS PHONE NO : 949 635 6240 22942 ARROYO VISTA SE DECISION MADE: 30-JUL-09 RANCHO SANTA MARGARITA CA 92688 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HDC STERILE SELF LIGATING SPIDER SCREW, MODEL SLI,SL2 HDC S.R.L. 510(k) NO: K091390(SPECIAL)
ATTN: GUIDO BONAPACE PHONE NO : 393 355 378686 VIA BORGO SANTA CRISTINA,12 SE DECISION MADE: 30-JUL-09 IMOLA, BOLOGNA IT 4026 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BUPRENORPHINE ENZYME IMMUNOASSAY WITH NORBUPRENORPHINE CALIBRATORS AND CONTROLS LIN-ZHI INTERNATIONAL, INC. 510(k) NO: K090844(TRADITIONAL)
ATTN: MARIE LIN PHONE NO : 408 732 3856 687 NORTH PASTORIA AVE. SE DECISION MADE: 30-JUL-09 SUNNYVALE CA 94085 2917 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MANTRA COMBO, MODEL MECS 320 MANTRA INTL. (HK) LTD. 510(k) NO: K091236(TRADITIONAL)
ATTN: BRENT REIDER PHONE NO : 750 549 5700 4663 KATE LANE SE DECISION MADE: 30-JUL-09 OXFORD OH 45056 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LNCS OXIMETRY SENSORS MASIMO CORPORATION 510(k) NO: K083719(TRADITIONAL)
ATTN: MARGUERITE THOMLINSON PHONE NO : 949 297 7000 40 PARKER SE DECISION MADE: 30-JUL-09 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NFOCUS NEUROMEDICAL ECHO DISTAL ACCESS CATHETER NFOCUS NEUROMEDICAL, INC. 510(k) NO: K090918(TRADITIONAL)
ATTN: BOB FOUNDS PHONE NO : 650 845 3064 2191 E. BAYSHORE ROAD SUITE 100 SE DECISION MADE: 30-JUL-09 PALO ALTO CA 94303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOVAPRO STRETCH VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE) NOVAPRO CO., LTD. 510(k) NO: K091422(TRADITIONAL)
ATTN: ZHENZHONG CHENG PHONE NO : 86 533 7480108 NO. 21 QINGTIAN ROAD LOT 4 SE DECISION MADE: 30-JUL-09 ZIBO, SHANDONG CH 255414 510(k) STATEMENT DEVICE: TDS ZIRCONIA ABUTMENT FOR NOBEL BIOCARE BRANEMARK POU YU BIOTECHNOLOGY CO., LTD. 510(k) NO: K091693(TRADITIONAL)
ATTN: DANIEL TSAO PHONE NO : 886 476 85660 NO. 6, FUGONG RD. SE DECISION MADE: 30-JUL-09 FUSING TOWNSHIP, CHANGHUA CTY T510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TDS TITANIUM ABUTMENT FOR NOBEL BIOCARE BRANEMARK POU YU BIOTECHNOLOGY CO., LTD. 510(k) NO: K091392(TRADITIONAL)
ATTN: DANIEL TSAO PHONE NO : 886 047 685660 NO. 6, FUGONG RD. SE DECISION MADE: 30-JUL-09 FUSING TOWNSHIP, CHANGHUA CTY T510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEOSALUS LOTION QUINNOVA PHARMACEUTICALS 510(k) NO: K091719(TRADITIONAL)
ATTN: SHAHBAZ KHAN PHONE NO : 215 550 2005 411 S. STATE ST. 3RD. FLOOR SE DECISION MADE: 30-JUL-09 NEWTOWN PA 18940 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RECRUIT MICROCATHETER REVERSE MEDICAL CORPORATION 510(k) NO: K091563(TRADITIONAL)
ATTN: AMY ESKINA PHONE NO : 949 215 0660 13900 ALTON PARKWAY SUITE 123 SE DECISION MADE: 30-JUL-09 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: THERAFORM STANDARD/SHEET SEWON CELLONTECH CO., LTD. 510(k) NO: K090812(TRADITIONAL)
ATTN: JUNG BAE BANG PHONE NO : 562 404 8466 13340 E. FIRESTONE BLVD. SUITE J SE DECISION MADE: 30-JUL-09 SANTA FE SPRINGS CA 90670 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM SMITH & NEPHEW, INC. 510(k) NO: K092015(SPECIAL)
ATTN: DAVID HENLEY PHONE NO : 901 399 6487 1450 BROOKS RD. SE DECISION MADE: 30-JUL-09 MEMPHIS TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELASTO-GEL MANUKA HONEY WOUND DRESSING SOUTHWEST TECHNOLOGIES, INC. 510(k) NO: K083334(TRADITIONAL)
ATTN: EDWARD STOUT PHONE NO : 816 221 2442 1746 LEVEE RD. SE DECISION MADE: 30-JUL-09 KANSAS CITY MO 64116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE , MODEL 9076 VERTEBRAL TECHNOLOGIES, INC. 510(k) NO: K091988(SPECIAL)
ATTN: SURESH GHAI PHONE NO : 952 979 9357 5909 BAKER ROAD SUITE 550 SE DECISION MADE: 30-JUL-09 MINNETONKA MN 55345 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATLAS WOUND MATRIX WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K090954(TRADITIONAL)
ATTN: RYAN M BELANEY PHONE NO : 901 867 4778 5677 AIRLINE RD. SE DECISION MADE: 30-JUL-09 ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FORTEX PEDICLE SCREW SYSTEM X-SPINE SYSTEMS, INC. 510(k) NO: K090224(SPECIAL)
ATTN: DAVID KIRSCHMAN PHONE NO : 937 847 8400 452 ALEXANDERSVILLE RD. SE DECISION MADE: 30-JUL-09 MIAMISBURG OH 45342 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDERED VINYL PATIENT EXAMINATION GLOVES ZHANG JIA GANG FENGYUAN PLASTIC PR510(k) NO: K091662(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 86 108 2387441 RM.1606 BLDG.1, JIANXIANG YUAN NO.SE DECISION MADE: 30-JUL-09 BEIJING CH 10083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNIVERSAL CLAMP STAINLESS STEEL SYSTEM, MODELS SNA027-0-30060, SNA027-0-30063 ZIMMER SPINE, INC 510(k) NO: K091190(SPECIAL)
ATTN: HEATHER CRAWFORD PHONE NO : 512 533 1961 5301 RIATA PARK COURT BUILDING F SE DECISION MADE: 30-JUL-09 AUSTIN TX 78727 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATLAS IMPLANT SYSTEM - WIDE PLUS COWELLMEDI CO., LTD 510(k) NO: K090054(TRADITIONAL)
ATTN: JUNG BAE BANG PHONE NO : 562 404 8466 13340 E. FIRESTONE BLVD. SUITE J SE DECISION MADE: 29-JUL-09 SANTA FE SPRINGS CA 90670 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEART-EXERCISE GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K091594(TRADITIONAL)
ATTN: PATRICIA TAIGE PHONE NO : 414 721 3222 9900 INNOVATION DRIVE SE DECISION MADE: 29-JUL-09 WAUWATOSA WI 53226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PILLCAM PLATFORM WITH PILLCAM SB CAPSULES WITH PILLCAM SENSORBELT GIVEN IMAGING LTD. 510(k) NO: K091405(SPECIAL)
ATTN: TIM THOMAS PHONE NO : 770 662 0870 NEW INDUSTRIAL PARK P.O. BOX 258 SE DECISION MADE: 29-JUL-09 YOQNEAM IS 20692 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PANTA NAIL (DIA. 10MM), PANTA NAIL XL NEWDEAL SAS 510(k) NO: K091788(SPECIAL)
ATTN: JUDITH O'GRADY PHONE NO : 609 936 2311 311 ENTERPRISE DR. SE DECISION MADE: 29-JUL-09 PLAINSBORO NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO OLYMPUS CAPSULE ENDOSCOPE SYSTEM OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K090210(SPECIAL) ATTN: STACY ABBATIELLO KLUESNER PHONE NO : 484 896 5405 3500 CORPORATE PARKWAY PO BOX 610 SE DECISION MADE: 29-JUL-09 CENTER VALLEY PA 18034 0610 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MOD1T COMPENSATORS FOR RADIATION BEAM THERAPY ONCOLOGY TECH, LLC 510(k) NO: K091403(TRADITIONAL)
ATTN: SEAN COMER PHONE NO : 210 497 2100 5608 BUSINESS PARK SE DECISION MADE: 29-JUL-09 SAN ANTONIO TX 78218 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PONTO PRO OTICON MEDICAL AB 510(k) NO: K090996(TRADITIONAL)
ATTN: KAROLIN ISBERG PHONE NO : 463 174 86100 EKONOMIV 2 SE DECISION MADE: 29-JUL-09 GOTHENBURG, ASKIM SW SE-436 33 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLANMECA PROSENSOR PLANMECA OY 510(k) NO: K091197(TRADITIONAL)
ATTN: BOB PIENKOWSKI PHONE NO : 630 529 2300 100 NORTH GARY AVE. SUITE A SE DECISION MADE: 29-JUL-09 ROSELLE IL 60172 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BULLSEYE BILIARY STENT SYSTEM SQUAREONE 510(k) NO: K082093(TRADITIONAL)
ATTN: ERIC ANKERUD PHONE NO : 978 302 9467 510 CLYDE AVENUE SE DECISION MADE: 29-JUL-09 MOUNTAIN VIEW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEUROSIGN AVALANCHE MOTOR NERVE MONITOR THE MAGSTIM COMPANY LTD. 510(k) NO: K083242(TRADITIONAL)
ATTN: ANWEN EVANS PHONE NO : 44 199 4240798 SPRING GARDENS WHITLAND SE DECISION MADE: 29-JUL-09 CARMARTHENSHIRE, WALES UK SA34 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MOXIE PLASTIC APPLICATOR AND MOXIE NON-APPLICATOR TAMPON TOSAMA D.D. 510(k) NO: K092054(SPECIAL)
ATTN: ANTONIJA VIDENSEK PHONE NO : 386 172 90370 SARANOVICEVA CESTA 035 SE DECISION MADE: 29-JUL-09 VIR, DOMZALE SI 1230 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 4.0R001 TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K092179(TRADITIONAL)
ATTN: PHONE NO : 2441 MICHELLE DR. SE DECISION MADE: 29-JUL-09 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: POWDER FREE BLUE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL WRP ASIA PACIFIC SDN. BHD. 510(k) NO: K083409(TRADITIONAL)
ATTN: KIRK PENNER PHONE NO : 603 870 61486 LOT 1, JALAN 3, KAWASAN PERUSAHAANSE DECISION MADE: 29-JUL-09 SALAK TINGGI, SEPANG SELANGOR M510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AL T LASER, MODEL AVI HPLL-12 AVICENNA LASER TECHNOLOGY, INC. 510(k) NO: K091285(TRADITIONAL)
ATTN: BRUCE COREN PHONE NO : 561 722 1153 9822 EAST WASHINGTON ST. SUITE 6 SE DECISION MADE: 28-JUL-09 CHAGRIN FALLS OH 44023 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA) EUROIMMUN US INC 510(k) NO: K083052(TRADITIONAL)
ATTN: KATHRYN KOHL PHONE NO : 973 270 0912 95 WASHINGTON ST SE DECISION MADE: 28-JUL-09 MORRISTOWN NJ 07960 510(k) STATEMENT DEVICE: HAEMOBAND MULTI-LIGATOR HAEMOBAND SURGICAL LTD. 510(k) NO: K091519(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239 498 2155 24301 WOODSAGE DRIVE SE DECISION MADE: 28-JUL-09 BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHARP CHUTE HEATHROW SCIENTIFIC, LLC 510(k) NO: K091690(TRADITIONAL)
ATTN: PETE HADJIS PHONE NO : 847 816 5070 620 LAKEVIEW PKWY SE DECISION MADE: 28-JUL-09 VERNON HILLS IL 60061 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: NAVIJECT SUB2-1P, MODEL: LP604430 MEDICEL AG 510(k) NO: K092023(SPECIAL)
ATTN: GEORGE MYERS PHONE NO : 201 727 1703 377 ROUTE 17 S SE DECISION MADE: 28-JUL-09 HASBROUCK HEIGHTS NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM MEDISON CO., LTD. 510(k) NO: K092159(TRADITIONAL)
ATTN: SHIM KYUNG-AM PHONE NO : 82 2 21941381 1003, DAECHI-DONG GANGNAM-GU SE DECISION MADE: 28-JUL-09 SEOUL KS 135-280 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PLS PORTABLE LIGHT SOURCE OPTIM, INC. 510(k) NO: K091829(ABBREVIATED)
ATTN: ROBERT KRUPA PHONE NO : 508 347 5100 64 TECHNOLOGY PARK RD. SE DECISION MADE: 28-JUL-09 STURBRIDGE MA 01566 1262 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PMT HALO SYSTEM PMT CORP. 510(k) NO: K090733(TRADITIONAL)
ATTN: ERIC CAILLE PHONE NO : 952 470 0866 1500 PARK RD. P.O. OX 610 SE DECISION MADE: 28-JUL-09 CHANHASSEN MN 55317 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHILIPS NM3 MONITOR, MODEL 7900 RESPIRONICS NOVAMETRIX LLC 510(k) NO: K091459(SPECIAL)
ATTN: KEVIN MADER PHONE NO : 203 697 6466 5 TECHNOLOGY DRIVE SE DECISION MADE: 28-JUL-09 WALLINGFORD CT 06492 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES ULTRAWIN SDN BHD 510(k) NO: K090828(TRADITIONAL)
ATTN: MAH SIEW HOE PHONE NO : 605 201 3888 LOT 2, PESIARAN PERINDUSTRIAN KANTSE DECISION MADE: 28-JUL-09 CHEMOR, PERAK MY 31200 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCUPEN ACCUTOME ULTRASOUND, INC. 510(k) NO: K083377(TRADITIONAL)
ATTN: BRIAN T.S. BARRETT PHONE NO : 610 889 0200 263 GREAT VALLEY PARKWAY SE DECISION MADE: 27-JUL-09 MALVERN PA 19355 510(k) STATEMENT DEVICE: THERMOFLO HCH, THERMOFLO FILTER ARC MEDICAL, INC. 510(k) NO: K090738(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239 498 2155 24301 WOODSAGE DRIVE SE DECISION MADE: 27-JUL-09 BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-2730 BIO-RAD LABORATORIES, INC. 510(k) NO: K090699(TRADITIONAL)
ATTN: JACKIE H BUCKLEY PHONE NO : 510 741 5309 4000 ALFRED NOBEL DR SE DECISION MADE: 27-JUL-09 HERCULES CA 94547 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLOBAL SHOULDER STEPTECH ANCHOR PEG GLENOID DEPUY ORTHOPAEDICS, INC. 510(k) NO: K092122(SPECIAL)
ATTN: RHONDA MYER PHONE NO : 574 371 4927 700 ORTHOPAEDIC DR. SE DECISION MADE: 27-JUL-09 WARSAW IN 46581 0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WALK400H ET MEDICAL DEVICES SPA 510(k) NO: K091054(ABBREVIATED) ATTN: LUIGO BUCCHI PHONE NO : 390 295 051854 6, VIA DE ZINIS SE DECISION MADE: 27-JUL-09 CAVARENO(TN) IT 38011 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALPINE PEDICLE SCREW SYSTEM SANACOR 510(k) NO: K090477(TRADITIONAL)
ATTN: MICHAEL ENSIGN PHONE NO : 801 358 9986 PO BOX 1196 SE DECISION MADE: 27-JUL-09 PLEASANT GROVE UT 84062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) SMART GLOVE CORP. SDN BHD 510(k) NO: K091147(TRADITIONAL)
ATTN: FOO KHON PU PHONE NO : 603 329 16100 BATU 5 3/4, JALAN KAPAR KLANG SE DECISION MADE: 27-JUL-09 SELANGOR DARUL ESHAN MY 42100 510(k) STATEMENT DEVICE: SONOLITH I-SYS LITHOTRIPER TECHNOMED MEDICAL SYSTEMS, SA 510(k) NO: K083614(ABBREVIATED)
ATTN: LYNETTE L HOWARD PHONE NO : 908 788 4580 106 EAST 5TH AVENUE SE DECISION MADE: 27-JUL-09 MOUNT DORA FL 32757 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPI DENTAL IMPLANT INICELL THOMMEN MEDICAL, AG 510(k) NO: K090154(TRADITIONAL)
ATTN: LINDA K SCHULZ PHONE NO : 858 792 1235 11234 EL CAMINO REAL, SUITE 200 SE DECISION MADE: 27-JUL-09 SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES ZHANG JIA GANG FENGYUAN PLASTIC PR510(k) NO: K091663(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 86 108 2387441 RM.1606 BLDG.1, JIANXIANG YUAN NO.SE DECISION MADE: 27-JUL-09 BEIJING CH 10083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES ZHANG JIA GANG HUAYUAN PLASTIC CO.510(k) NO: K091661(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 86 108 2387441 RM.1606 BLDG.1, JIANXIANG YUAN NO.SE DECISION MADE: 27-JUL-09 HAIDIAN DISTRICT, BEIJING CH 10510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT ADVANDX, INC. 510(k) NO: K083074(TRADITIONAL)
ATTN: PAULA E BULGER PHONE NO : 339 227 4072 10A ROESSLER ROAD SE DECISION MADE: 24-JUL-09 WOBURN MA 01801 510(k) STATEMENT DEVICE: KNEEHAB XP CONDUCTIVE GARMENT, TYPE 411 BIO-MEDICAL RESEARCH, LTD. 510(k) NO: K083105(TRADITIONAL)
ATTN: ANNE-MARIE KEENAN PHONE NO : 353 91 774300 PARKMORE BUSINESS PARK WEST SE DECISION MADE: 24-JUL-09 GALWAY EI 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JUMAO OXYGEN CONCENTRATOR, MODEL JM-07000HI, JM-07000I, JM-07000 DANYANG JUMAO HEALTHCARE EQUIPMENT510(k) NO: K090007(TRADITIONAL)
ATTN: QING WANG PHONE NO : 865 118 6379811 NO.89 SHUANGFENG ROAD, JIEPAI TOWNSE DECISION MADE: 24-JUL-09 DANYANG CITY,JIANGSU PROVINCE C510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ELATION MB METAL REINFORCED PLASTIC BRACKET DENTSPLY INTERNTIONAL 510(k) NO: K092030(SPECIAL)
ATTN: HELEN LEWIS PHONE NO : 717 845 7511 221 W. PHILADELPHIA ST. STE.60 SUSSE DECISION MADE: 24-JUL-09 YORK PA 17405 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LATERAL COLUMN LENGTH PLATE, MODEL 824073000-3, LOCKED FUSION PLATE, MODEL 824077010, COMPRESSION FUSION PLATE, DEPUY ORTHOPAEDICS, INC. 510(k) NO: K091294(TRADITIONAL)
ATTN: SUZANA OTANO PHONE NO : 305 269 6386 700 ORTHOPAEDIC DR. SE DECISION MADE: 24-JUL-09 WARSAW IN 46581 0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMART ECG SERIES ELECTROCARDIOGRAPH, MODELS SE-3, SE-300A AND 300B, SE-6, SE-600, SE-12, SE-12 EXPRESS AND SE-1200 EDAN INSTRUMENTS, INC. 510(k) NO: K091513(TRADITIONAL)
ATTN: WILLIAM STERN PHONE NO : 914 376 5200 1 ODELL PLAZA SE DECISION MADE: 24-JUL-09 YONKERS NY 10701 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: IMAGINE TC SKIN THERAPY SYSTEM ENDYMION MEDICAL LTD 510(k) NO: K083461(TRADITIONAL)
ATTN: YORAM LEVY PHONE NO : 972 463 88837 31 HAAVODA ST. SE DECISION MADE: 24-JUL-09 BINYAMINA IS 30500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REUSABLE ENVITEC FINGER SPO2 SENSOR-HP/PHILIPS COMPATIBLE, MODELS F-2412, F-2414-15, REUSABLE ENVITEC EAR SPO2 SENSOR ENVITEC-WISMAR GMBH 510(k) NO: K090438(TRADITIONAL)
ATTN: STEPHEN GORSKI PHONE NO : 262 594 2114 S65 W35739 PIPER ROAD SE DECISION MADE: 24-JUL-09 EAGLE WI 53119 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM, CHARCX, INTRAMEDULLARY SCREW SYSTEM EXTREMITY MEDICAL LLC 510(k) NO: K091577(TRADITIONAL)
ATTN: JAMY GANNOE PHONE NO : 973 588 8980 300 INTERPACE PARKWAY SUITE 410 SE DECISION MADE: 24-JUL-09 PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MR-TOUCH OPTION GE MEDICAL SYSTEMS, LLC 510(k) NO: K083421(TRADITIONAL)
ATTN: DANIEL BIANK PHONE NO : 262 521 6467 3200 N. GRANDVIEW BLVD. SE DECISION MADE: 24-JUL-09 WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300 HEARTFORCE MEDICAL, INC. 510(k) NO: K081603(TRADITIONAL)
ATTN: ARTHUR WARD PHONE NO : 813 645 2855 962 ALLEGRO LANE SE DECISION MADE: 24-JUL-09 APOLLO BEACH FL 33572 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER HSINER CO., LTD. 510(k) NO: K091185(TRADITIONAL)
ATTN: TOM SHANKS PHONE NO : 951 506 2674 29201 VIA NORTE SE DECISION MADE: 24-JUL-09 TEMECULA CA 92591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE IVY BIOMEDICAL SYSTEMS, INC. 510(k) NO: K091985(SPECIAL)
ATTN: DICK LISTRO PHONE NO : 203 481 4183 11 BUSINESS PARK DR. SE DECISION MADE: 24-JUL-09 BRANFORD CT 06405 510(k) STATEMENT DEVICE: THERAFIRM ANTI-EMBOLISM STOCKINGS, THERAFIRM MEN'S AND WOMEN'S TROUSER SOCKS KNIT-RITE, INC. 510(k) NO: K091141(TRADITIONAL)
ATTN: JEFFREY C DALBEY PHONE NO : 913 279 6366 126 MILL STREET SE DECISION MADE: 24-JUL-09 ELLERBE NC 28338 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM MEDTOX DIAGNOSTICS, INC. 510(k) NO: K091454(TRADITIONAL)
ATTN: PHILLIP HARTZOG PHONE NO : 336 226 6311 1238 ANTHONY RD. SE DECISION MADE: 24-JUL-09 BURLINGTON NC 27215 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST NANOSPHERE, INC 510(k) NO: K083294(TRADITIONAL)
ATTN: GREGORT W SHIPP PHONE NO : 847 400 9115 4088 COMMERCIAL AVENUE SE DECISION MADE: 24-JUL-09 NORTHBROOK IL 60062 510(k) STATEMENT DEVICE: EXTRAFIX EXTERNAL FIXATION SYSTEM QFX TECHNOLOGIES, INC. 510(k) NO: K091258(TRADITIONAL)
ATTN: MARCOS VELEZ-DURAN PHONE NO : 703 562 9800 901 KING STREET SUITE 200 SE DECISION MADE: 24-JUL-09 ALEXANDRIA VA 22314 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RAMP RSV ASSAY RESPONSE BIOMEDICAL CORP. 510(k) NO: K091235(TRADITIONAL)
ATTN: KEN PILGRIM PHONE NO : 604 456 6010 1781 - 75TH AVENUE W. SE DECISION MADE: 24-JUL-09 VANCOUVER, B.C CA V6P 6P2 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: E-STATIS 40 SYSTEM SCICAN LTD. 510(k) NO: K090937(TRADITIONAL)
ATTN: BRENDA MURPHY PHONE NO : 416 446 2797 1440 DON MILLS RD. SE DECISION MADE: 24-JUL-09 TORONTO, ONTARIO CA M3B 3P9 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUBIC AND RABEA DEVICES SIGNUS MEDIZINTECHNIK GMBH 510(k) NO: K082848(TRADITIONAL)
ATTN: KAREN E WARDEN PHONE NO : 440 729 8457 8202 SHERMAN ROAD SE DECISION MADE: 24-JUL-09 CHSETERLAND OH 44026 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPINAL EDGE TITAN PEDICLE SCREW SYSTEM SPINAL EDGE, LLC 510(k) NO: K091110(TRADITIONAL)
ATTN: CHRISTINA VACCA PHONE NO : 440 937 4068 33650 RESERVE WAY SE DECISION MADE: 24-JUL-09 AVON OH 44011 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PICA WHOLE BODY MRI SYSTEM TIME MEDICAL LIMITED 510(k) NO: K091580(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 862 164 684973 SUITE 8D,NO.19, LANE 999 ZHONGSHANSE DECISION MADE: 24-JUL-09 SHANGHAI CH 200030 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: BENACEL UNICARE BIOMEDICAL 510(k) NO: K090612(TRADITIONAL)
ATTN: STAN YANG PHONE NO : 949 643 6707 22971 TRITON WAY SE DECISION MADE: 24-JUL-09 LAGUNA HILLS CA 92653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASCENT PORCELAIN PRIMER, MODEL 006-00078, 00600079 CAO GROUP, INC. 510(k) NO: K091300(TRADITIONAL)
ATTN: ROBERT LARSON PHONE NO : 801 256 9282 4628 WEST SKYHAWK DRIVE SE DECISION MADE: 23-JUL-09 WEST JORDAN UT 84084 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDIOTECH SPIROMETRY SYSTEM, MODEL GT-105 CHEST M.I., INC. 510(k) NO: K090646(TRADITIONAL)
ATTN: JEAN ASQUITH PHONE NO : 512 327 9997 1705 S. CAPITAL OF TEXAS HWY SUITESE DECISION MADE: 23-JUL-09 AUSTIN TX 78746 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNIVERSAL, AESTHETICA, NATEA, NATURA EUROTEKNIKA 510(k) NO: K083670(TRADITIONAL)
ATTN: EMMANUEL MONTINI PHONE NO : 514 927 4635 1100 RENE-LEVESQUE-BLVD WEST -25THSE DECISION MADE: 23-JUL-09 MONTREAL, QUEBEC CA H3B 5C9 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSUFLOW CO2IONSHIELD LEXION MEDICAL, LLC. 510(k) NO: K090879(TRADITIONAL)
ATTN: BERNARD HORWATH PHONE NO : 651 361 8041 5000 TOWNSHIP PKWY SE DECISION MADE: 23-JUL-09 ST. PAUL MN 55110 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFEGUARD BACKTRACK B90 BREATH ALCOHOL TESTER LIFELOC TECHNOLOGIES, INC. 510(k) NO: K090766(TRADITIONAL) ATTN: MARK LARY PHONE NO : 720 317 2195 12441 W. 49TH AVE. SUITE 4 SE DECISION MADE: 23-JUL-09 WHEAT RIDGE CO 80033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VASCU-PICC AND MIDLINE CATHETERS, SINGLE, DOUBLE AND TRIPLE LUMEN MEDCOMP 510(k) NO: K091586(TRADITIONAL)
ATTN: JEAN CALLOW PHONE NO : 215 256 4201 1499 DELP DR. SE DECISION MADE: 23-JUL-09 HARLEYSVILLE PA 19438 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOLO INSULIN PATCH PUMP MEDINGO LTD. 510(k) NO: K090245(TRADITIONAL)
ATTN: ARAVA HACOHEN PHONE NO : 972 737 131313 YOQNEAM INDUSTRIAL PARK BLDG.7 3RDSE DECISION MADE: 23-JUL-09 YOQNEAM IS 20692 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOVAPRO VINYL EXAMINATION GLOVE POWDER FREE (NON-COLORED) NOVAPRO CO., LTD. 510(k) NO: K091421(TRADITIONAL)
ATTN: ZHENZHONG CHENG PHONE NO : 86 533 7480108 NO. 21 QINGTIAN ROAD LOT 4 SE DECISION MADE: 23-JUL-09 ZIBO, SHANDONG CH 255414 510(k) STATEMENT DEVICE: OMNI 5 TOTAL O2 DELIVERY SYSTEM RESPIRONICS, INC. 510(k) NO: K091028(SPECIAL)
ATTN: ZITA A YURKO PHONE NO : 724 387 4120 1001 MURRY RIDGE LN. SE DECISION MADE: 23-JUL-09 MURRYSVILLE PA 15668 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAS INFLUENZA A & B TEST SA SCIENTIFIC, INC. 510(k) NO: K080380(TRADITIONAL)
ATTN: ROBBI PERRY PHONE NO : 210 699 8800 4919 GOLDEN QUAIL SE DECISION MADE: 23-JUL-09 SAN ANTONIO TX 78240 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IONOLUX VOCO GMBH 510(k) NO: K090817(TRADITIONAL)
ATTN: M.TH. PLAUMANN PHONE NO : 49 472 1719200 ANTON-FLETTNER-STRASSE 1-3 SE DECISION MADE: 23-JUL-09 CUXHAVEN GM D-27472 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TEMPORARY C&B COMPOSITE VOCO GMBH 510(k) NO: K091894(SPECIAL)
ATTN: T. GERKENSMEIER PHONE NO : 494 721 719200 ANTON-FLETTNER-STRASSE 1-3 SE DECISION MADE: 23-JUL-09 CUXHAVEN GM D-27472 510(k) STATEMENT DEVICE: ALATECH POWDER FREE LATEX EXAMINATION GLOVE ALATECH HEALTHCARE, LLC. 510(k) NO: K083761(ABBREVIATED)
ATTN: NEIL ANDERSON PHONE NO : 334 688 8520 1600 STATE DOCKS RD. SE DECISION MADE: 22-JUL-09 EUFAULA AL 36027 510(k) STATEMENT DEVICE: ADKINS STRUT BIOMET MICROFIXATION, INC. 510(k) NO: K091058(TRADITIONAL)
ATTN: KIM REED PHONE NO : 904 741 9443 1520 TRADEPORT DR. SE DECISION MADE: 22-JUL-09 JACKSONVILLE FL 32218 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEUCE POLYPECTOMY SNARE, MODELS 000995, 000996,000997, 000998 CONMED ENDOSCOPIC TECHNOLOGIES, IN510(k) NO: K091355(TRADITIONAL)
ATTN: KAREN PROVENCHER PHONE NO : 978 934 7832 ONE EXECUTIVE DRIVE SUITE 101 SE DECISION MADE: 22-JUL-09 CHELMSFORD MA 01824 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTENER ENDOGASTRIC SOLUTIONS, INC. 510(k) NO: K091832(SPECIAL)
ATTN: STEVE HOFFMAN PHONE NO : 425 307 9226 8210 154TH AVE. NE SE DECISION MADE: 22-JUL-09 REDMOND WA 98052 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PG471W , PG471/50W, PG474W, PG477W, PG479/32W, PG479/50W, PG479/75W FIAB DISPOSABLE ELECTRODES WITH CABLE FOR ELECTRO-ST FIAB SPA 510(k) NO: K091163(TRADITIONAL)
ATTN: ALBERTO CALABRO PHONE NO : 390 558 497914 VIA COSTOLI, 4 VICCHIO SE DECISION MADE: 22-JUL-09 FIRENZE IT 50039 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GCUC-505 GC AMERICA, INC. 510(k) NO: K091388(TRADITIONAL)
ATTN: MARK HEISS PHONE NO : 708 897 4042 3737 WEST 127TH ST. SE DECISION MADE: 22-JUL-09 ALSIP IL 60803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE INTERACOUSTICS AS 510(k) NO: K090406(TRADITIONAL)
ATTN: HANNE NIELSEN PHONE NO : 45 637 13555 DREJERVAENGET 8 SE DECISION MADE: 22-JUL-09 ASSENS DA DK-5610 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONQUEST SPINAL SYSTEM LIFE SPINE 510(k) NO: K090320(SPECIAL)
ATTN: MURALI AUDIPUDY PHONE NO : 847 884 6117 2401 W. HASSELL RD. SUITE 1535 SE DECISION MADE: 22-JUL-09 HOFFMAN ESTATES IL 60169 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUVASIVE SPHERX II SYSTEM NUVASIVE, INC. 510(k) NO: K091502(SPECIAL)
ATTN: HAN FAN PHONE NO : 858 909 3338 7475 LUSK BLVD SE DECISION MADE: 22-JUL-09 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005, COAC22003 PERCUTANEOUS SYSTEMS, INCORPORATED510(k) NO: K090485(TRADITIONAL)
ATTN: THOMAS LAWSON PHONE NO : 650 493 4200 3260 HILLVIEW AVENUE SE DECISION MADE: 22-JUL-09 PALO ALTO CA 94304 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMPLANT CENTER 2 SATELEC 510(k) NO: K091252(TRADITIONAL)
ATTN: RICK ROSATI PHONE NO : 800 289 6367 124 GAITHER DRIVE SUITE 140 SE DECISION MADE: 22-JUL-09 MT. LAUREL NJ 08054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VINYL POWDER FREE EXAMINATION GLOVE SHUN DA (XINGHUA) CO., LTD 510(k) NO: K091429(TRADITIONAL)
ATTN: ZHANG YAN PHONE NO : 86 523 83102233 LOT20, TIAN SHUI HUA TING YUAN XIASE DECISION MADE: 22-JUL-09 JIANGSU CH 225700 510(k) STATEMENT DEVICE: VINYL POWDER FREE EXAMINATION GLOVE SHUN TONG CO., LTD 510(k) NO: K091383(TRADITIONAL)
ATTN: CHEE HOONG TAN PHONE NO : 865 238 3263528 NORTH OF GAO XING TONG ROAD ECONOMSE DECISION MADE: 22-JUL-09 XINGHUA CITY, JIANGSU CH 225700510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS, MODEL B1017 SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K091264(TRADITIONAL)
ATTN: SHANNON POPSON PHONE NO : 916 374 3330 1584 ENTERPRISE BLVD SE DECISION MADE: 22-JUL-09 WEST SACRAMENTO CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACTICOAT FLEX 7 DRESSING SMITH & NEPHEW, INC. 510(k) NO: K083113(TRADITIONAL)
ATTN: TERRY MCMAHON PHONE NO : 727 392 1261 970 LAKE CARILLON DR. SUITE 110 SE DECISION MADE: 22-JUL-09 ST. PETERSBURG FL 33716 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDERED VINYL PATIENT EXAMINATION GLOVES TANGSHAN DAR PLASTIC & RUBBER PROD510(k) NO: K082647(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 86 108 2387441 RM.1606 BLDG.1 JIANXIANG YUAN NO.2SE DECISION MADE: 22-JUL-09 BEIJING CH 10083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPIDWER SINGLE PORT SURGICAL DEVICE, SUPPORT ARM ACCESSORY, MODEL 90001, 90002, 90003 TRANSENTERIX, INC. 510(k) NO: K090902(TRADITIONAL)
ATTN: TAMMY CARREA PHONE NO : 919 541 9977 3908 PATRIOT DRIVE STE 170 SE DECISION MADE: 22-JUL-09 DURHAM NC 27540 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BOLUS COMPENSATOR .DECIMAL, INC. 510(k) NO: K091911(SPECIAL)
ATTN: DANIEL L BENNETT PHONE NO : 407 330 3300 121 CENTRAL PARK PLACE SE DECISION MADE: 21-JUL-09 SANFORD FL 32771 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEM IRHYTHM TECHNOLOGIES, INC. 510(k) NO: K091075(TRADITIONAL)
ATTN: MICHAEL RIGHTER PHONE NO : 415 632 5700 650 TOWNSEND STREET SUITE 380 SE DECISION MADE: 21-JUL-09 SAN FRANCISCO CA 94103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP LABORIE MEDICAL TECHNOLOGIES, LTD.510(k) NO: K090830(TRADITIONAL)
ATTN: BARBARA MORNET PHONE NO : 802 857 1300 400 AVENUE D SUITE 10 SE DECISION MADE: 21-JUL-09 WILLISTON VT 05495 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GOLD ANCHOR NASLUND MEDICAL AB 510(k) NO: K091645(TRADITIONAL)
ATTN: TOMAS NASLUND PHONE NO : 46 732 620717 VASSVAGEN 21 SE DECISION MADE: 21-JUL-09 HUDDINGE SW 14139 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EZ HSG CATHETER.FOAMSEAL CATHETER OBG PRODUCTS 510(k) NO: K083594(TRADITIONAL)
ATTN: AL MUZZAMMEL PHONE NO : 703 893 9411 8292C OLD COURTHOUSE RD. SE DECISION MADE: 21-JUL-09 VIENNA VA 22182 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PARI PEP S PARI RESPIRATORY EQUIPMENT, INC. 510(k) NO: K090829(TRADITIONAL)
ATTN: MICHAEL JUDGE PHONE NO : 804 253 7274 2943 OAKLAKE BLVD. SE DECISION MADE: 21-JUL-09 MIDLOTHIAN VA 23112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QXLINK VIEWORKS CO., LTD. 510(k) NO: K092081(TRADITIONAL)
ATTN: CHARLIE MACK PHONE NO : 931 937 8093 340 SHADY GROVE ROAD SE DECISION MADE: 21-JUL-09 FLINTVILLE TN 37335 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: FLORASEAL, MODEL FS350D ADHEZION BIOMEDICAL 510(k) NO: K083354(ABBREVIATED)
ATTN: RICHARD JONES PHONE NO : 828 728 6116 506 PINE MOUNTAIN RD SE DECISION MADE: 20-JUL-09 HUDSON NC 28638 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STIMULUS/DISSECTION INSTRUMENTS AXON SYSTEMS, INC. 510(k) NO: K090838(TRADITIONAL)
ATTN: HOWARD BAILIN PHONE NO : 631 436 5112 80-5 DAVIDS DRIVE SE DECISION MADE: 20-JUL-09 HAUPPAUGE NY 11788 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MD300K1 PULSE OXIMETER BEIJING CHOICE ELECTRONIC TECHNOLO510(k) NO: K090599(TRADITIONAL)
ATTN: YAJING LI PHONE NO : 86 108 8790480 NORTH BUILDING 3F, NO.9 SHUANGYUANSE DECISION MADE: 20-JUL-09 SHIJINGSHAN DISTRICT, BEIJING C510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BREATHE TECHNOLOGIES, INC. 510(k) NO: K082982(TRADITIONAL)
ATTN: CRAIG COOMBS PHONE NO : 510 337 0140 1193 SHERMAN ST. SE DECISION MADE: 20-JUL-09 ALAMEDA CA 94501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DRX-EVOLUTION, MODEL VX3733-SYS CARESTREAM HEALTH, INC. 510(k) NO: K091889(SPECIAL)
ATTN: CAROLYN WAGNER PHONE NO : 585 627 6588 150 VERONA STREET SE DECISION MADE: 20-JUL-09 ROCHESTER NY 14608 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DERMAPORT PORTED VASCULAR ACCESS SYSTEM (PVAS) DERMAPORT, INC 510(k) NO: K091760(SPECIAL)
ATTN: JENNIFER HESSEL PHONE NO : 661 362 7904 25102 RYE CANYON LOOP SUITE 110 SE DECISION MADE: 20-JUL-09 SANTA CLARITA CA 91355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LEKSELL GAMMAPLAN ELEKTA INSTRUMENT AB 510(k) NO: K090972(SPECIAL)
ATTN: ANDERS SKOGLUND PHONE NO : 46 8 58725400 KUNGSTENSGATAN 18 P.O.BOX 7593 SE DECISION MADE: 20-JUL-09 STOCKHOLM SW S-103 93 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROGENY VANTAGE PANORAMIC X-RAY SYSTEM MIDMARK 510(k) NO: K091866(TRADITIONAL)
ATTN: ALAN KREMA PHONE NO : 847 415 9800 675 HEATHROW DR. SE DECISION MADE: 20-JUL-09 LINCOLNSHIRE IL 60069 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PERFSCAPE OLEA MEDICAL 510(k) NO: K091444(TRADITIONAL)
ATTN: NEAL KOLBER PHONE NO : 512 327 9997 1705 S. CAPITAL OF TEXAS HWY SUITESE DECISION MADE: 20-JUL-09 AUSTIN TX 78746 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VINYL POWDERED EXAMINATION GLOVE SHUN TONG CO., LTD 510(k) NO: K091384(TRADITIONAL)
ATTN: CHEE HOONG TAN PHONE NO : 865 238 3263528 NORTH OF GAO XING TONG ROAD ECONOMSE DECISION MADE: 20-JUL-09 XINGHUA CITY, JIANGSU CH 225700510(k) STATEMENT DEVICE: CHROMID MRSA AGAR, MODEL: REF 43 841 BIOMERIEUX, INC. 510(k) NO: K091024(TRADITIONAL)
ATTN: NANCY WEAVER PHONE NO : 314 731 8695 595 ANGLUM RD. SE DECISION MADE: 17-JUL-09 HAZELWOOD MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOVISION DIGITAL SPECIMEN RADIOGRAPHY SYSTEM BIOPTICS, INC. 510(k) NO: K091558(TRADITIONAL)
ATTN: CARLOS REYES PHONE NO : 520 399 8169 3440 E BRITANNIA DR SUITE 150 SE DECISION MADE: 17-JUL-09 TUCSON AZ 85743 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTIMA MR450W GE MEDICAL SYSTEMS, LLC 510(k) NO: K091536(TRADITIONAL)
ATTN: MARK STAUFFER PHONE NO : 262 521 6891 3200 N. GRANDVIEW BLVD. SE DECISION MADE: 17-JUL-09 WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ADHESE ONE F IVOCLAR VIVADENT, INC. 510(k) NO: K090941(TRADITIONAL)
ATTN: DONNA MARIE HARTNETT PHONE NO : 716 691 0010 175 PINEVIEW DR. SE DECISION MADE: 17-JUL-09 AMHERST NY 14228 510(k) STATEMENT DEVICE: EASYRA DLDL REAGENT, CALIBRATOR EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTES MEDICA CORP. 510(k) NO: K090734(TRADITIONAL)
ATTN: PHOTIOS MAKRIS PHONE NO : 781 275 4892 5 OAK PARK DRIVE SE DECISION MADE: 17-JUL-09 BEDFORD MA 01730 510(k) STATEMENT DEVICE: STARLIGHT ORTHOMERICA PRODUCTS, INC. 510(k) NO: K090587(SPECIAL)
ATTN: ALAN T SANDIFER PHONE NO : 407 290 6592 6333 N. ORANGE BLOSSOM TRAIL SE DECISION MADE: 17-JUL-09 ORLANDO FL 32810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CX50 VERSION 2.0 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS PHILIPS ULTRASOUND, INC. 510(k) NO: K091804(TRADITIONAL)
ATTN: ROB BUTLER PHONE NO : 978 659 2785 3000 MINUTEMAN RD. SE DECISION MADE: 17-JUL-09 ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: POLYTEL GMA, MODELS PWR-08-67, PWR-08-07, PWR-08-09 POLYMAP WIRELESS 510(k) NO: K091296(ABBREVIATED)
ATTN: PIERRE LANDAU PHONE NO : 520 747 1811 310 S. WILLIAMS BLVD, STE. 346 SE DECISION MADE: 17-JUL-09 TUCSON AZ 85711 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNGO VOLUME PERFUSION-CT BODY SIEMENS AG, MEDICAL SOLUTIONS 510(k) NO: K092013(TRADITIONAL)
ATTN: PHONE NO : SIEMENSSTRASSE 1 SE DECISION MADE: 17-JUL-09 FORCHHEIM GM 91301 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: QMS LIDOCAINE CALIBRATORS, MODEL 0374678 THERMO FISHER SCIENTIFIC 510(k) NO: K091617(TRADITIONAL)
ATTN: JACK ROGERS PHONE NO : 317 610 3823 7998 GEORGETOWN ROAD SUITE 1000 SE DECISION MADE: 17-JUL-09 INDIANAPOLIS IN 46268 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACTHERM DIGITAL CLINICAL THERMOMETER PROBE COVERS, MODEL(S) MEDACCU1010, MEDACCU1010-1, MEDACCU1020 ACTHERM, INC. 510(k) NO: K083419(TRADITIONAL)
ATTN: RICHARD HSIEH PHONE NO : 886 366 69596 6F, NO.18 JHANYE 2ND RD., HSINCHU SE DECISION MADE: 16-JUL-09 HSINCHU TW 30078 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MONACO RTP SYSTEM, VMAT OPTION COMPUTERIZED MEDICAL SYSTEMS, INC.510(k) NO: K091179(TRADITIONAL)
ATTN: KATHRYN STINSON PHONE NO : 314 993 0003 13723 RIVERPORT DR SUITE 100 SE DECISION MADE: 16-JUL-09 MARYLAND HEIGHTS MO 63043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE COVIDIEN LP, FORMERLY REGISTERED A510(k) NO: K091900(SPECIAL)
ATTN: REBECCA RONNER PHONE NO : 203 492 5438 60 MIDDLETOWN AVENUE SE DECISION MADE: 16-JUL-09 NORTH HAVEN CT 06473 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SILENT SLEEP CRANIOFACIAL PAIN CENTER OF IDAHO 510(k) NO: K082849(ABBREVIATED)
ATTN: JAMISON R SPENCER PHONE NO : 208 376 3600 8119 USTICK ROAD SE DECISION MADE: 16-JUL-09 BOISE ID 83704 510(k) STATEMENT DEVICE: AKLARUS PHOTOTHERAPY SYSTEM HILL LABORATORIES CO. 510(k) NO: K083183(TRADITIONAL)
ATTN: BRADY ALLER PHONE NO : 610 644 2867 3 N. BACTON HILL RD. SE DECISION MADE: 16-JUL-09 FRAZER PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SQ IS SYSTEM NEOBIOTECH CO., LTD. 510(k) NO: K090825(TRADITIONAL)
ATTN: EUGENE BANG PHONE NO : 562 404 8466 13340E FIRESTONE BLVD. STE. J SE DECISION MADE: 16-JUL-09 SANTE FE SPRINGS CA 90670 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VICTORY XL 130 FOUR WHEEL SCOOTER, MODEL SC713 PRIDE MOBILITY PRODUCTS CORP. 510(k) NO: K092088(SPECIAL)
ATTN: KIMBERLY BLAKE PHONE NO : 570 655 5574 182 SUSQUEHANNA AVE. SE DECISION MADE: 16-JUL-09 EXETER PA 18643 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMITH & NEPHEW RF CANNULATE SMITH & NEPHEW, INC. 510(k) NO: K090955(TRADITIONAL)
ATTN: MASON W ROBBINS PHONE NO : 901 399 6021 1450 BROOKS RD. SE DECISION MADE: 16-JUL-09 MEMPHIS TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E XOFT, INC. 510(k) NO: K090914(TRADITIONAL)
ATTN: STEVE LIN PHONE NO : 408 419 2341 345 POTRERO AVE. SE DECISION MADE: 16-JUL-09 SUNNYVALE CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3200 3M COMPANY 510(k) NO: K083903(TRADITIONAL)
ATTN: JIZHONG JIN PHONE NO : 651 733 6655 3M CENTER, BLDG. 275-5W-06 SE DECISION MADE: 15-JUL-09 ST. PAUL MN 55144 1000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PASSPORT V MONITOR, MODEL 0998-00-6100 DATASCOPE CORP., PATIENT MONITORIN510(k) NO: K091834(SPECIAL)
ATTN: KATHLEEN KRAMER PHONE NO : 201 995 8169 800 MACARTHUR BLVD. SE DECISION MADE: 15-JUL-09 MAHWAH NJ 07430 0619 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONICAID FM820 AND FM830 ENCORE HUNTLEIGH HEALTHCARE LTD. 510(k) NO: K090285(TRADITIONAL)
ATTN: GRAHAM BOOTH PHONE NO : 44 292 0485885 35 PORTMANMOOR RD. SE DECISION MADE: 15-JUL-09 CARDIFF, SOUTH WALES UK CF24 5H510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO MEDICOMPASS CONNECT IMETRIKUS, INC. 510(k) NO: K091021(TRADITIONAL)
ATTN: MICHAEL ACOSTA PHONE NO : 650 396 1220 2141 LANDINGS DRIVE SE DECISION MADE: 15-JUL-09 MOUNTAIN VIEW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TIGRT TPS LINATECH, LLC 510(k) NO: K090893(TRADITIONAL)
ATTN: JONATHAN YAO PHONE NO : 408 733 2051 1294 KIFER ROAD # 705 SE DECISION MADE: 15-JUL-09 SUNNYVALE CA 94086 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TALOS INTERVERTEBRAL BODY FUSION DEVICE MEDITECH ADVISORS, LLC 510(k) NO: K090707(TRADITIONAL)
ATTN: JANET M WEBB PHONE NO : 312 643 1306 950 N. MICHIGAN AVE. SUITE 2202 SE DECISION MADE: 15-JUL-09 CHICAGO IL 60611 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K091442(SPECIAL)
ATTN: BRAD SHEALS PHONE NO : 901 396 3133 PYRAMID PLACE SE DECISION MADE: 15-JUL-09 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PASCAL PHOTOCOAGULATOR, PASCAL-US OPTIMEDICA CORPORATION 510(k) NO: K091666(SPECIAL)
ATTN: DARLENE CROCKETT-BILLIG PHONE NO : 408 400 0856 155-A MOFFIT PARK DRIVE SUITE 210 SE DECISION MADE: 15-JUL-09 SUNNYVALE CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STOCKERT CENTRIFUGAL PUMP PLUS SYSTEM (SCP PLUS), MODELS 60-00-10, 60-00-55 SORIN GROUP DEUTSCHLAND GMBH 510(k) NO: K091008(SPECIAL)
ATTN: ROSINA ROBINSON PHONE NO : 508 643 0434 49 PLAIN STREET SE DECISION MADE: 15-JUL-09 NORTH ATTLEBORO MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TREU BONE SCREWS, SCHANZ SCREWS, KIRSCHNER WIRES, STEINMANN PINS, LARSEN PINS TREU-INSTRUMENTE GMBH 510(k) NO: K083912(TRADITIONAL)
ATTN: FRANZ MENEAN PHONE NO : 49 746 3995411 GRIESWEG 47 SE DECISION MADE: 15-JUL-09 MUHLHEIM, BADEN-WURTTEMBERG GM 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIMED STERILE PRODUCT TRIMED, INC. 510(k) NO: K091156(SPECIAL)
ATTN: KELLI ANDERSON PHONE NO : 661 312 7150 28337 MAITLAND LANE SE DECISION MADE: 15-JUL-09 SAUGUS CA 91350 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORONIS 5MP HD, MODEL MDMG 5121 BARCOVIEW, MEDICAL IMAGING SYSTEMS510(k) NO: K091274(SPECIAL)
ATTN: LIEVEN DE WANDEL PHONE NO : 325 623 3459 35 PRESIDENT KENNEDYPARK SE DECISION MADE: 14-JUL-09 KORTRIJK BE B-8500 510(k) STATEMENT DEVICE: AP-1000 BLOOD GLUCOSE MONITORING SYSTEM BESTGEN BIOTECH CORP. 510(k) NO: K090389(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 3 5208829 NO. 58 FU CHIUN STREET SE DECISION MADE: 14-JUL-09 HSIN CHU CITY TW 30067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WATERLASE C100, MODEL 7100104 BIOLASE TECHNOLOGY, INC. 510(k) NO: K091922(SPECIAL)
ATTN: IOANA RIZOIU PHONE NO : 949 226 8144 4 CROMWELL SE DECISION MADE: 14-JUL-09 IRVINE CA 92618 1816 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 5.5 POLARIS SPINAL SYSTEM BIOMET SPINE 510(k) NO: K091067(SPECIAL)
ATTN: VIVIAN KELLY PHONE NO : 973 299 9300 100 INTERPACE PARKWAY SE DECISION MADE: 14-JUL-09 PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEPUY DELTA XTEND REVERSE SHOULDER XLK CUP DEPUY ORTHOPAEDICS, INC. 510(k) NO: K091751(SPECIAL)
ATTN: DAWN SINCLAIR PHONE NO : 574 372 5023 700 ORTHOPAEDIC DR. SE DECISION MADE: 14-JUL-09 WARSAW IN 46581 0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZYFUSE FACET FIXATION SYSTEM GLOBUS MEDICAL, INC. 510(k) NO: K090952(TRADITIONAL)
ATTN: KELLY J BAKER PHONE NO : 610 415 9000 2560 GENERAL ARMISTEAD AVE. VALLEYSE DECISION MADE: 14-JUL-09 AUDUBON PA 19403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LDR SPINE CERVICAL INTERBODY FUSION SYSTEM LDR SPINE USA 510(k) NO: K091088(TRADITIONAL)
ATTN: NOAH BARTSCH PHONE NO : 512 344 3319 4030 WEST BRAKER LANE SUITE 360 SE DECISION MADE: 14-JUL-09 AUSTIN TX 78759 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MINITAPE URETHRAL SLING MPATHY MEDICAL DEVICES, LTD. 510(k) NO: K091180(SPECIAL)
ATTN: CAROLINE STRETTON PHONE NO : 441 417 736244 LONMAY ROAD QUEENSLIE SE DECISION MADE: 14-JUL-09 GLASGOW UK G33 4EL 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SINUS QUICK IT SYSTEM NEOBIOTECH CO., LTD. 510(k) NO: K090527(TRADITIONAL)
ATTN: JUNG BAE BANG PHONE NO : 562 404 8466 13340E FIRESTONE BLVD. STE. J SE DECISION MADE: 14-JUL-09 SANTE FE SPRINGS CA 90670 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RALCO, MODEL R225 ACS RALCO S.R.L. 510(k) NO: K091517(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847 374 8854 333 MILFORD ROAD SE DECISION MADE: 14-JUL-09 DEERFIELD IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PORTABLE X-RAY SYSTEM, MODEL POWERMAX 1260 SOURCE-RAY, INC. 510(k) NO: K090655(TRADITIONAL)
ATTN: RAY MANEZ PHONE NO : 631 244 8200 167 KEYLAND CT. SE DECISION MADE: 14-JUL-09 BOHEMIA NY 11716 510(k) STATEMENT DEVICE: NUTRAC PELVATOR, MODEL PEL 200 VERITY SCIENTIFIC LTD. 510(k) NO: K083704(TRADITIONAL)
ATTN: BRENT REIDER PHONE NO : 750 549 5700 4663 KATE LANE SE DECISION MADE: 14-JUL-09 OXFORD OH 45056 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VALOR ANKLE FUSION NAIL SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K090857(TRADITIONAL)
ATTN: KELLEN HILLS PHONE NO : 901 290 5816 5677 AIRLINE RD. SE DECISION MADE: 14-JUL-09 ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) REAGENT, MODEL A60291 BECKMAN COULTER, INC. 510(k) NO: K091153(TRADITIONAL)
ATTN: MARINE BOYAJIAN PHONE NO : 714 961 6536 200 SOUTH KRAEMER BLVD. M/S W-110 SE DECISION MADE: 13-JUL-09 BREA CA 92822 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APTUS FOOT SYSTEM MEDARTIS AG 510(k) NO: K091479(TRADITIONAL)
ATTN: LINDA SCHULZ PHONE NO : 858 792 1235 11234 EL CAMINO REAL, STE 200 SE DECISION MADE: 13-JUL-09 SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: U-RIGHT TD-4227 NO CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4222 TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K090188(TRADITIONAL)
ATTN: YUHUA CHEN PHONE NO : 886 2 66258188 6F, NO. 127, WUGONG 2ND RD WUGU TOSE DECISION MADE: 13-JUL-09 TAIPEI COUNTY TW 241 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COOK UROLOGICAL GRAFT COOK BIOTECH, INC. 510(k) NO: K090688(TRADITIONAL)
ATTN: MARY A FADERAN PHONE NO : 765 497 3355 1425 INNOVATION PLACE SE DECISION MADE: 10-JUL-09 WEST LAFAYETTE IN 47906 1000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS DIPURE, LLC. 510(k) NO: K083712(TRADITIONAL)
ATTN: TIM MARCO PHONE NO : 713 686 4049 1919 EDWARDS STREET SE DECISION MADE: 10-JUL-09 HOUSTON TX 77007 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GMK TOTAL KNEE SYSTEM MEDACTA INTERNATIONAL, SA 510(k) NO: K090988(TRADITIONAL)
ATTN: NATALIE J KENNEL PHONE NO : 858 705 0350 13721 VIA TRES VISTA SE DECISION MADE: 10-JUL-09 SAN DIEGO CA 92129 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEWDEAL HALLU LOCK PLATE SYSTEM NEWDEAL SAS 510(k) NO: K083154(TRADITIONAL)
ATTN: JUDITH O'GRADY PHONE NO : 609 936 2311 311 ENTERPRISE DR. SE DECISION MADE: 10-JUL-09 PLAINSBORO NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: M3 MONITOR SPECTRUM MEDICAL LTD 510(k) NO: K091908(TRADITIONAL)
ATTN: STEVE TURNER PHONE NO : 440 124 2650121 HARRIER 4,METEOR BUSINESS PARK CHESE DECISION MADE: 10-JUL-09 GLOUCESTER, GLOUCESTERHSIRE UK 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SYNAPSE SYSTEM 4.0MM, OC FUSION SYSTEM 4.0MM SYNTHES (USA) 510(k) NO: K091689(SPECIAL)
ATTN: STACEY BONNELL PHONE NO : 610 719 5895 1302 WRIGHTS LANE EAST SE DECISION MADE: 10-JUL-09 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES ORACLE PLATE SYNTHES SPINE 510(k) NO: K091159(TRADITIONAL)
ATTN: STACEY BONNELL PHONE NO : 610 719 5895 1302 WRIGHTS LANE EAST SE DECISION MADE: 10-JUL-09 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMPLATZER TORQVUE 3 DELIVERY SHEATH, MODEL 9-TV3-08F104, 9-TV3-08F54 AGA MEDICAL CORP. 510(k) NO: K091793(SPECIAL)
ATTN: DIANE CARROLL PHONE NO : 763 531 3161 5050 NATHAN LANE NORTH SE DECISION MADE: 09-JUL-09 PLYMOUTH MN 55442 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REFRESH OPTIVE LENS COMFORT REWETTING DROPS ALLERGAN, INC. 510(k) NO: K083812(TRADITIONAL)
ATTN: BEVERLEY D VENUTI PHONE NO : 978 658 6888 269A BALLARDVALE STREET SE DECISION MADE: 09-JUL-09 WILMINGTON MA 01887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEL MAR MONOAXIAL PEDICLE SCREW SYSTEM ALLEZ SPINE, LLC 510(k) NO: K091219(SPECIAL)
ATTN: HARTMUT LOCH PHONE NO : 949 752 7885 2301 DUPONT DRIVE, SUITE 510 SE DECISION MADE: 09-JUL-09 IRVINE CA 92612 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALARIS PC UNIT, MODELS 8000 AND 8015 CARDINAL HEALTH 303, INC. 510(k) NO: K091308(TRADITIONAL)
ATTN: MICHELLE J BADAL PHONE NO : 858 617 5925 10020 PACIFIC MESA BLVD. SE DECISION MADE: 09-JUL-09 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XPERT C. DIFFICILE CEPHEID 510(k) NO: K091109(TRADITIONAL)
ATTN: RUSSEL K ENNS PHONE NO : 408 400 8230 904 CARIBBEAN DRIVE SE DECISION MADE: 09-JUL-09 SUNNYVALE CA 94089 1189 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AIRCAST VENAFLOW ELITE SYSTEM DJO, LLC 510(k) NO: K091700(SPECIAL)
ATTN: CHRISTINE OTIS PHONE NO : 760 734 3504 1430 DECISION STREET SE DECISION MADE: 09-JUL-09 VISTA CA 92081 8553 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: H-WAVE SPORT ELECTRONIC WAVEFORM LABORATORY, IN510(k) NO: K081998(TRADITIONAL)
ATTN: RYAN P HEANEY PHONE NO : 800 874 9283 16168 BEACH BLVD., SUITE 232 SE DECISION MADE: 09-JUL-09 HUNTINGTON BEACH CA 92647 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RAINBOW RESPOSABLE PULSE CO-OXIMETER SENSORS, MODELS R2C-25, R2-25, R2C-20 AND R2-20 MASIMO CORPORATION 510(k) NO: K090165(TRADITIONAL)
ATTN: MARGUERITE THOMLINSON PHONE NO : 949 297 7000 40 PARKER SE DECISION MADE: 09-JUL-09 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MASIMO RAINBOW SET PRONTO PULSE CO-OXIMETER AND ACCESSORIES MASIMO CORPORATION 510(k) NO: K091057(SPECIAL)
ATTN: MARGUERITE THOMLINSON PHONE NO : 949 297 7258 40 PARKER SE DECISION MADE: 09-JUL-09 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EASY.TOUCH INSULIN SYRINGE MASTERS HEALTHCARE, LLC. 510(k) NO: K091474(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847 374 8854 333 MILFORD RD. SE DECISION MADE: 09-JUL-09 DEERFIELD IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPY SCOPE INTRA-OPERATIVE OPERATING SYSTEM NOVADAQ TECHNOLOGIES, INC. 510(k) NO: K091515(TRADITIONAL)
ATTN: JOHN FENGLER PHONE NO : 604 232 9861 2585 SKYMARK AVENUE, STE. 306 SE DECISION MADE: 09-JUL-09 MISSISSAUGA, ONTARIO CA L4W 4L5510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEOBASE NON-DERIVATIZED MSMS KIT, MODEL 3040 PERKINELMER, INC. 510(k) NO: K083130(TRADITIONAL)
ATTN: KAY A TAYLOR PHONE NO : 317 418 1735 8275 CARLOWAY ROAD SE DECISION MADE: 09-JUL-09 INDIANAPOLIS IN 46236 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LITHO LASER SYSTEM QUANTA SYSTEM, S.P.A. 510(k) NO: K091909(TRADITIONAL)
ATTN: ISABELLA CARRER PHONE NO : 390 331 37679 VIA IV NOVEMBRE,116 SE DECISION MADE: 09-JUL-09 SOLBIATE OLONA(VA) IT 21058 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K091941(TRADITIONAL)
ATTN: TAN CHUANBIN PHONE NO : 86 755 26582888 MINDRAY BLDG,KEJI 12TH RD. S. HI-TSE DECISION MADE: 09-JUL-09 NANSHAN, SHENZHEN, GUANGDONG CH510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG CENTURY PLASTIC CO., 510(k) NO: K091523(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441 RM 1606 BLDG.1 JIANXIZNG YUAN, NO.SE DECISION MADE: 09-JUL-09 BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM SIS LTD. SURGICAL INSTRUMENT SYSTE510(k) NO: K082871(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720 962 5412 5401 COTTONWOOD CT. SE DECISION MADE: 09-JUL-09 GREENWOOD VILLAGE CO 80121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RANASYS EZ NEGATIVE PRESSURE WOUND THERAPY SYSTEM, MODEL 66800059 SMITH & NEPHEW, INC. 510(k) NO: K091470(TRADITIONAL)
ATTN: LAURA KREJCI PHONE NO : 727 329 7702 970 LAKE CARILLON DR. SUITE 110 SE DECISION MADE: 09-JUL-09 ST. PETERSBURG FL 33716 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OXYALERT NIRSENSORS, ACCESSORIES FOR INVOS 5100C SYSTEM, MODELS: IS-C AND IS-S SOMANETICS CORP. 510(k) NO: K091224(SPECIAL)
ATTN: RONALD A WIDMAN PHONE NO : 248 689 3050 1653 EAST MAPLE RD. SE DECISION MADE: 09-JUL-09 TROY MI 48083 4208 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPINAL USA ANTERIOR LUMBAR PLATE SYSTEM SPINAL USA 510(k) NO: K091044(SPECIAL)
ATTN: JEFFEREY JOHNSON PHONE NO : 601 420 4244 2050 EXECUTIVE DR. SE DECISION MADE: 09-JUL-09 PEARL MS 39208 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECSCOPE 200 DYANSYS, INC. 510(k) NO: K091397(TRADITIONAL)
ATTN: SRINI NAGESHWAR PHONE NO : 650 354 8447 577 AIRPORT BLVD. SUITE 610 SE DECISION MADE: 08-JUL-09 BURLINGAME CA 95032 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT) ENTELLUS MEDICAL, INC. 510(k) NO: K091681(SPECIAL)
ATTN: DEBORAH I NEYMARK PHONE NO : 763 463 7056 6705 WEDGWOOD COURT NORTH SE DECISION MADE: 08-JUL-09 MAPLE GROVE MN 55311 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM MICROVENTION, INC. 510(k) NO: K091882(SPECIAL)
ATTN: NAOMI GONG PHONE NO : 949 951 0592 75 COLUMBIA SE DECISION MADE: 08-JUL-09 ALISO VIEJO CA 92656 1408 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ONCE-A-DAY VERTOS TEST PACK PROPPER MFG. CO., INC. 510(k) NO: K082620(ABBREVIATED)
ATTN: MARIAN M SCHUMAN PHONE NO : 800 832 4300 36-04 SKILLMAN AVE. SE DECISION MADE: 08-JUL-09 LONG ISLAND CITY NY 11101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REST ASSURED GENERATION II DENTAL PROTECTOR RANIR CORPORATION 510(k) NO: K091792(SPECIAL)
ATTN: JEFF FISHER PHONE NO : 616 698 8880 555 THIRTEENTH STREET, NW SE DECISION MADE: 08-JUL-09 WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES ZIBO YUSHENG PLASTIC PRODUCTS CO.,510(k) NO: K091431(TRADITIONAL)
ATTN: JOHN ZHAO PHONE NO : 909 548 4828 12390 EAST END AVE. SE DECISION MADE: 08-JUL-09 CHINO CA 91710 510(k) STATEMENT DEVICE: ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM ALPHATEC SPINE, INC. 510(k) NO: K090779(SPECIAL)
ATTN: CHERYL ALLEN PHONE NO : 760 494 6770 5818 EL CAMINO REAL SE DECISION MADE: 07-JUL-09 CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPE SYSTEM AVANTIS MEDICAL SYSTEMS, INC. 510(k) NO: K091783(SPECIAL)
ATTN: AMRITA SETHI PHONE NO : 408 733 1901 263 SANTA ANA CT. SE DECISION MADE: 07-JUL-09 SUNNYVALE CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STREAMER POLYMER GUIDEWIRE BRIVANT, LTD. 510(k) NO: K083094(TRADITIONAL)
ATTN: TOMAS FUREY PHONE NO : 353 913 85037 PARKMORE WEST BUSINESS PARK SE DECISION MADE: 07-JUL-09 GALWAY EI 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORTEX DENTAL IMPLANT SYSTEM CORTEX DENTAL IMPLANTS INDUSTRIES,510(k) NO: K090709(TRADITIONAL)
ATTN: BENNY AZARY PHONE NO : 972 499 40337 INDUSTRIAL PARK 13 SE DECISION MADE: 07-JUL-09 MIZPE AVIV, M.P. MISGAV IS 2018510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PACSMATE, MODEL MMD-4300C/MMD-4300CX IEI TECHNOLOGY CORP. 510(k) NO: K091687(TRADITIONAL)
ATTN: JENNIFER REICH PHONE NO : 928 773 6340 2904 N. BOLDT DRIVE SE DECISION MADE: 07-JUL-09 FLAGSTAFF AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMARTSCREENER-PLUS2 INTELLIGENT HEARING SYSTEMS 510(k) NO: K090579(TRADITIONAL)
ATTN: EDWARD MISKIEL PHONE NO : 305 668 6102 6860 S.W. 81ST ST. SE DECISION MADE: 07-JUL-09 MIAMI FL 33143 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TIGRT MLC, TIGRT DMLC LINATECH, LLC 510(k) NO: K090802(TRADITIONAL)
ATTN: JONATHAN YAO PHONE NO : 408 733 2051 1294 KIFER ROAD # 705 SE DECISION MADE: 07-JUL-09 SUNNYVALE CA 94086 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PACS PLUS 5TH EDITION MEDICAL STANDARD CO., LTD. 510(k) NO: K083658(TRADITIONAL)
ATTN: BRANDON CHOI PHONE NO : 714 523 1592 49 CANDLEWOOD WAY SE DECISION MADE: 07-JUL-09 BUENA PARK CA 90638 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER MIDMARK CORP. 510(k) NO: K090670(TRADITIONAL)
ATTN: GARY BENNING PHONE NO : 937 526 8357 60 VISTA DR. P.O. BOX 286 SE DECISION MADE: 07-JUL-09 VERSAILLES OH 45380 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: POWDER- FREE NITRILE EXAMINATION GLOVES, BLACK COLOR SHEN WEI (USA), INC. 510(k) NO: K090194(TRADITIONAL)
ATTN: BELLE CHOU PHONE NO : 510 429 8692 33278 CENTRAL AVE., SUITE 102 SE DECISION MADE: 07-JUL-09 UNION CITY CA 94587 510(k) STATEMENT DEVICE: MODIFICATION TO:LATARJET CORTICAL SCREW SET, MODELS 523JT, 523J (36-48MM) T.A.G. MEDICAL PRODUCTS 510(k) NO: K091694(SPECIAL)
ATTN: GEORGIE J HATTUB PHONE NO : 508 479 6116 291 HILLSIDE AVENUE SE DECISION MADE: 07-JUL-09 SOMERSET MA 02726 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TANITA BODY COMPOSITION ANALYZER, MODEL SC-331 TANITA CORPORATION OF AMERICA 510(k) NO: K090479(TRADITIONAL)
ATTN: TOSHIHIKO ISHIKAWA PHONE NO : 847 593 3915 2625 SOUTH CLEARBROOK DRIVE SE DECISION MADE: 07-JUL-09 ARLINGTON HEIGHTS IL 60005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BANTAM ALTIMATE MEDICAL, INC. 510(k) NO: K091242(TRADITIONAL)
ATTN: CAROLL L MARTIN PHONE NO : 440 329 6356 ONE INVACARE WAY SE DECISION MADE: 06-JUL-09 ELYRIA OH 44035 4190 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BECE PRESS BEGO BREMER GOLDSCHLAEGEREI WILH. 510(k) NO: K090434(TRADITIONAL)
ATTN: MICHAEL ESSLER PHONE NO : 494 212 028138 WILHELM-HERBST-STRASSE 1 SE DECISION MADE: 06-JUL-09 BREMEN GM 28359 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C.T.M. MOBILITY SCOOTER, HS-528 C.T.M. HOMECARE PRODUCT, INC. 510(k) NO: K090735(TRADITIONAL)
ATTN: LINDA J BOVARD PHONE NO : 541 345 5431 29611 SIMMONS ROAD SE DECISION MADE: 06-JUL-09 EUGENE OR 97405 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C.T.M. MOBILITY SCOOTER, MODEL HS-628, INVACARE ORION C.T.M. HOMECARE PRODUCT, INC. 510(k) NO: K091418(TRADITIONAL)
ATTN: LINDA BOVARD PHONE NO : 541 345 5431 29611 SIMMONS ROAD SE DECISION MADE: 06-JUL-09 EUGENE OR 97405 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HUAYI K-SERIES LIGHTWEIGHT WHEELCHAIR K3/K4 DANYANG HUAYI MEDICAL SUPPLY & EQU510(k) NO: K091482(TRADITIONAL)
ATTN: JIUGUANG (JOE) SONG PHONE NO : 856 340 3572 3119 BRICK LANE SE DECISION MADE: 06-JUL-09 DECATUR GA 30033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWER STANDING DANI DAVISMADE, INC. 510(k) NO: K090256(TRADITIONAL)
ATTN: DANIEL DAVIS PHONE NO : 810 233 9706 2511 DAVISON RD SE DECISION MADE: 06-JUL-09 FLINT MI 48506 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FREEDOM SCIENCES MOTION CONTROL MODULE VERSION 1.5 FREEDOM SCIENCES, LLC 510(k) NO: K091723(SPECIAL)
ATTN: EDWARD A KROLL PHONE NO : 440 546 9810 5905 FAWN LANE SE DECISION MADE: 06-JUL-09 CLEVELAND OH 44141 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDICAL TREATMENT CHAIR, MODELS T100, T200, T300, T400 FRESENIUS MEDICAL CARE SOUTH ASIA 510(k) NO: K091727(TRADITIONAL)
ATTN: RAM KAMATH PHONE NO : 612 946 68023 LEVEL 17, 61 LAVENDER STREET SE DECISION MADE: 06-JUL-09 MILSONS POINT, NSW AS 2061 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MITAKA UNIARM MITAKA KOHKI CO., LTD. 510(k) NO: K090792(TRADITIONAL)
ATTN: MAXWELL STURGIS PHONE NO : 435 649 2236 2337 LUCKY JOHN DRIVE SE DECISION MADE: 06-JUL-09 PARK CITY UT 84060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING TEST, ESENSOR INSTRUMENT, MODELS XT-8 OSMETECH MOLECULAR DIAGNOSTICS 510(k) NO: K090901(TRADITIONAL)
ATTN: ROBERT S DICHECK PHONE NO : 626 463 2000 757 SOUTH RAYMOND AVE. SE DECISION MADE: 06-JUL-09 PASADENA CA 91105 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MILI (MINIMALLY INVASIVE LUMBAR IMPLANT) SYSTEM AESCULAP IMPLANT SYSTEMS, INC. 510(k) NO: K083004(TRADITIONAL)
ATTN: LISA BOYLE PHONE NO : 610 984 9274 3773 CORPORATE PWKY. SE DECISION MADE: 02-JUL-09 CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BAIXIN DISPOSABLE SYRINGE, MULTIPLE SIZES ANHUI KANGDA MEDICAL PRODUCTS CO.,510(k) NO: K083686(TRADITIONAL)
ATTN: BIAN WEI QIANG PHONE NO : 86 215 0324423 1707 YINQIAO BLDG. 58 JINXIN RD., SE DECISION MADE: 02-JUL-09 PUDONG, SHANGHAI CH 201206 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIS CLICK SENSOR/CABLE ASPECT MEDICAL SYSTEMS, INC. 510(k) NO: K091854(TRADITIONAL)
ATTN: VIKRAM VERMA PHONE NO : 617 559 7134 ONE UPLAND ROAD SE DECISION MADE: 02-JUL-09 NORWOOD MA 02062 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: BD FLU+ SYRINGE BECTON DICKINSON & CO. 510(k) NO: K091377(TRADITIONAL)
ATTN: EILEEN HILLER PHONE NO : 201 847 4570 1 BECTON DRIVE MC237 SE DECISION MADE: 02-JUL-09 FRANKLIN LAKES NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUITY MAILMAN AND STRAIT-TRAK GUIDEWIRE BOSTON SCIENTIFIC CORP. 510(k) NO: K090554(TRADITIONAL)
ATTN: STACEY A STRAND PHONE NO : 763 255 0688 ONE SCIMED PLACE SE DECISION MADE: 02-JUL-09 MAPLE GROVE MN 55311 1566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEFENDO (TM) BIOPSY VALVE FOR OLYMPUS(R) AND FUJINON(R) ENDOSCOPES, MODEL 100301, DEFENDO(TM) BIOPSY VALVE FOR PENTAX(R) BYRNE MEDICAL INC. 510(k) NO: K090851(TRADITIONAL)
ATTN: JENNIFER JAMES PHONE NO : 936 539 0391 3150 POLLOK DR SE DECISION MADE: 02-JUL-09 CONROE TX 77303 510(k) STATEMENT DEVICE: EVALVE STEERABLE GUIDE CATHETER, MODEL SGC01ST EVALVE INC 510(k) NO: K091596(SPECIAL)
ATTN: CINDY MORROW PHONE NO : 650 330 8100 4045 CAMPBELL AVENUE SE DECISION MADE: 02-JUL-09 MENLO PARK CA 94025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAMMOSITE II RADIATION THERAPY SYSTEM HOLOGIC, INC. 510(k) NO: K091378(SPECIAL)
ATTN: JENNIFER SULLIVAN PHONE NO : 508 263 8912 250 CAMPUS DRIVE SE DECISION MADE: 02-JUL-09 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KOWA VX-10 A KOWA CO. LTD. 510(k) NO: K091683(SPECIAL) ATTN: AKIHIRO FUJITA PHONE NO : 813 562 38049 4-14, NIHONBASHI-HONCHO 3-CHOME SE DECISION MADE: 02-JUL-09 CHUO-KU, TOKYO JA 103-8433 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: NUVASIVE SPHERX SYSTEM NUVASIVE, INC. 510(k) NO: K090981(SPECIAL)
ATTN: HAN FAN PHONE NO : 858 909 3338 7475 LUSK BLVD SE DECISION MADE: 02-JUL-09 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTEOMED HAND PLATE AND SCREW FIXATION SYSTEM OSTEOMED L.P. 510(k) NO: K090522(TRADITIONAL)
ATTN: ALMA RELJA PHONE NO : 972 677 4781 3885 ARAPAHO RD. SE DECISION MADE: 02-JUL-09 ADDISON TX 75001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECSYS PRECICONTROL UNIVERSAL ROCHE DIAGNOSTICS 510(k) NO: K090541(TRADITIONAL)
ATTN: GAIL SAUERS PHONE NO : 317 521 3225 9115 HAGUE ROAD PO BOX 50410 SE DECISION MADE: 02-JUL-09 INDIANAPOLIS IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMITH & NEPHEW INSTRUMENT TRAYS SMITH & NEPHEW, INC. 510(k) NO: K091627(SPECIAL)
ATTN: CHRISTINA FLORES PHONE NO : 508 261 3705 150 MINUTEMAN RD. SE DECISION MADE: 02-JUL-09 ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AIR PURGE CONTROL SYSTEM FOR S5 SYSTEM MODEL 23-45-05 SORIN GROUP DEUTSCHLAND GMBH 510(k) NO: K091007(SPECIAL)
ATTN: ROSINA ROBINSON PHONE NO : 508 643 0434 49 PLAIN STREET SE DECISION MADE: 02-JUL-09 NORTH ATTLEBORO MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CALCANEAL FRACTURE PLATE SYSTEM TORNIER, INC. 510(k) NO: K090582(TRADITIONAL)
ATTN: BRAHIM HADRI PHONE NO : 978 232 9997 100 CUMMINGS CENTER SUITE 444C SE DECISION MADE: 02-JUL-09 BEVERLY MA 01915 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DESTINY MAX COAGULATION ANALYZER TRINITY BIOTECH 510(k) NO: K083896(TRADITIONAL)
ATTN: BONNIE B DEJOY PHONE NO : 716 483 3851 2823 GIRTS ROAD SE DECISION MADE: 02-JUL-09 JAMESTOWN NY 14701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VORTEX CANNULA VORTEX MEDICAL INC 510(k) NO: K091304(TRADITIONAL)
ATTN: CHERYL BLAKE PHONE NO : 949 285 3517 50 LORING DRIVE SE DECISION MADE: 02-JUL-09 NORWELL MA 02061 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM B. BRAUN MEDICAL, INC. 510(k) NO: K083689(TRADITIONAL)
ATTN: LINDA MORGAN PHONE NO : 972 466 5070 1601 WALLACE DR., SUITE 150 SE DECISION MADE: 01-JUL-09 CARROLLTON TX 75006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD L-CATH SINGLE AND DUAL LUMENT CATHETERS, MIDLINE CATHETER BECTON DICKINSON & CO. 510(k) NO: K091670(SPECIAL)
ATTN: JUSTICE ALDER PHONE NO : 801 565 2300 9450 SOUTH STATE STREET SE DECISION MADE: 01-JUL-09 SANDY UT 84070 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE BELMONT FLUID MANAGEMENT SYSTEM/ THE BELMONT RAPID INFUSER, MODEL FMS2000 BELMONT INSTRUMENT CORP. 510(k) NO: K091855(SPECIAL) ATTN: URAIWAN LABADINI PHONE NO : 978 663 0212 780 BOSTON RD. SE DECISION MADE: 01-JUL-09 BILLERICA MA 01821 510(k) STATEMENT DEVICE: PLATELIA TOXO IGM KIT MODEL 26211 BIO-RAD LABORATORIES 510(k) NO: K090847(SPECIAL)
ATTN: PRIYA BONDRE PHONE NO : 425 498 1728 6565 185TH AVE, NE SE DECISION MADE: 01-JUL-09 REDMOND WA 98052 510(k) STATEMENT DEVICE: ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM BOSTON SCIENTIFIC CORPORATION 510(k) NO: K091816(SPECIAL)
ATTN: JANIS TARANTO PHONE NO : 508 683 4560 100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 01-JUL-09 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INFLATABLE BONE TAMP CARDINAL HEALTH, INC. 510(k) NO: K090211(TRADITIONAL)
ATTN: SHARON NICHOLS PHONE NO : 847 578 6610 1430 WAUKEGAN ROAD- MPKB-3B SE DECISION MADE: 01-JUL-09 MCGAW PARK IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: S12X WITH ESAX OPTION CHATTEN ASSOCIATES, INC. 510(k) NO: K082629(TRADITIONAL)
ATTN: JOHN B CHATTEN PHONE NO : 610 940 6040 1094 NEW DEHAVEN AVE SUITE 200 SE DECISION MADE: 01-JUL-09 WEST CONSHOHOCKEN PA 19428 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLAATZ 500 DRTECH CORP. 510(k) NO: K091747(TRADITIONAL)
ATTN: BEOM-JIN MOON PHONE NO : 82 31 7306800 333-1, SANGDEAWON 1-DONG JUNGWON-GSE DECISION MADE: 01-JUL-09 SEONGNAM-SHI, GYEONGGI-DO KS 46510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: POLARIS SPINAL SYSTEM EBI, L.P. 510(k) NO: K090523(TRADITIONAL)
ATTN: VIVIAN KELLY PHONE NO : 973 299 9300 100 INTERPACE PKWY. SE DECISION MADE: 01-JUL-09 PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACTIPROTECT UF N95 RESPIRATOR, DOUBLE STRAP, FLAT FOLD GLAXOSMITHKLINE CONSUMER HEALTHCAR510(k) NO: K081923(TRADITIONAL)
ATTN: ZINATARA A MANJI PHONE NO : 973 889 2322 1500 LITTLETON RD. SE DECISION MADE: 01-JUL-09 PARSIPPANY NJ 07054 3884 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RPL/CPL VERTICAL PLATFORM LIFTS HARMAR SUMMIT LLC 510(k) NO: K091881(TRADITIONAL)
ATTN: KEVIN KAMINSKI PHONE NO : 941 351 2776 2075 47TH STREET SE DECISION MADE: 01-JUL-09 SARASOTA FL 34234 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APTUS 2.0/2.3 FOUR CORNER FUSION PLATE MEDARTIS AG 510(k) NO: K090983(TRADITIONAL)
ATTN: KEVIN A THOMAS PHONE NO : 858 792 1235 11234 EL CAMINO REAL, STE 200 SE DECISION MADE: 01-JUL-09 SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MINIME PEDIATRIC MASK SLEEPNET CORPORATION 510(k) NO: K090935(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239 498 2155 24301 WOODSAGE DRIVE SE DECISION MADE: 01-JUL-09 BONITA SPRINGS FL 34134 2958 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPECTRANETICS TURBO-TANDEM SYSTEM SPECTRANETICS CORP. 510(k) NO: K091299(TRADITIONAL)
ATTN: GRACIE MURGUIA PHONE NO : 719 447 2567 9965 FEDERAL DRIVE SE DECISION MADE: 01-JUL-09 COLORADO SPRINGS CO 80921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MERCURY SPINAL SYSTEM SPINAL ELEMENTS, INC. 510(k) NO: K091587(SPECIAL)
ATTN: KERRI DIMARTINO PHONE NO : 760 607 1816 2744 LOKER AVE. W. SUITE 100 SE DECISION MADE: 01-JUL-09 CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59, DS2NO23-59, DS2N024-65, DS2N024-65, DS2N021-65, DS2 ST. JUDE MEDICAL, CARDIAC RHYTHM M510(k) NO: K090613(SPECIAL) ATTN: COLLEEN CANAN PHONE NO : 818 493 2960 15900 VALLEY VIEW CT. SE DECISION MADE: 01-JUL-09 SYLMAR CA 91342 510(k) STATEMENT DEVICE: PINNACLE STAIR WAY LIFT SUMMIT HARMAR, LLC 510(k) NO: K091858(TRADITIONAL)
ATTN: EDWARD KROL PHONE NO : 440 546 9810 5905 FAWN LANE SE DECISION MADE: 01-JUL-09 CLEVELAND OH 44144 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUNMAX ENTERPRISE SHANGHAI CO. POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS SUNMAX ENTERPRISE SHANGHAI CO. LTD510(k) NO: K090336(TRADITIONAL)
ATTN: JIGAR SHAH PHONE NO : 704 516 8197 55 NORTHERN BLVD. SUITE 200 SE DECISION MADE: 01-JUL-09 GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REACTION SYSTEM VIORA LTD. 510(k) NO: K090221(TRADITIONAL)
ATTN: JOSEF LUZON PHONE NO : 201 332 4100 30 MONTGOMERY STREET SUITE 660 SE DECISION MADE: 01-JUL-09 JERSEY CITY NJ 07302 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 284 TOTAL WITH SUMMARIES 258 TOTAL WITH STATEMENTS 26
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