SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE) 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD 01-NOV-2008 THROUGH 30-NOV-2008 DEVICE: REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529, REVEL DX INSER MEDTRONIC INC. 510(k) NO: K082475(TRADITIONAL)
ATTN: DEBBIE KIDDER PHONE NO : 763-526-3561 8200 CORAL SEA STREET NE SE DECISION MADE: 07-NOV-08 MOUNDS VIEW, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: A&D MEDICAL UA-851THW DIGITAL BLOOD PRESSURE MONITOR A & D ENGINEERING, INC. 510(k) NO: K082734(SPECIAL)
ATTN: JERRY WANG PHONE NO : 408-518-5113 1756 AUTOMATION PARKWAY SE DECISION MADE: 13-NOV-08 SAN JOSE, CA 95131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET, MODEL K707M- AALTO SCIENTIFIC LTD. 510(k) NO: K082714(TRADITIONAL)
ATTN: BRANDON J PEREZ PHONE NO : 760-431-7922 1959 KELLOGG AVE. SE DECISION MADE: 19-NOV-08 CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AARDVARK NASAL IRRIGATION AND ASPIRATION DEVICE AARDVARK MEDICAL 510(k) NO: K082762(TRADITIONAL)
ATTN: PHONE NO : PO BOX 1654 SE DECISION MADE: 12-NOV-08 ROSS, CA 94957 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: RELION ULTIMA ADVANCE BLOOD GLUCOSE MONITORING SYSTEM MODELS, BG ABBOTT DIABETES CARE INC. 510(k) NO: K081975(SPECIAL)
ATTN: ARUL STERLIN PHONE NO : 510-864-4310 1360 SOUTH LOOP RD. SE DECISION MADE: 26-NOV-08 ALAMEDA, CA 94502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SILVER ALGINATE IV ANTIMICROBIAL WOUND DRESSING ADVANCED MEDICAL SOLUTIONS LIMITED510(k) NO: K080503(TRADITIONAL)
ATTN: CLAIRE RYAN PHONE NO : 441 606 863500 ROAD THREE SE DECISION MADE: 12-NOV-08 WINSFORD INDUSTRIAL ESTATE 510(k) SUMMARY AVAILABLE FROM FDA WINSFORD CHESHIRE, UNITED KINGDOM CW7 3PD DEVICE: EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR ADVANCED STERILIZATION PRODUCTS 510(k) NO: K082392(SPECIAL)
ATTN: JOSEPH ASCENZI, PH.D. PHONE NO : 949-453-6352 33 TECHNOLOGY DR. SE DECISION MADE: 13-NOV-08 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOLOX DELTA CERAMIC FEMORAL HEAD AESCULAP IMPLANT SYSTEMS, INC. 510(k) NO: K082991(SPECIAL)
ATTN: KATHY A RACOSKY PHONE NO : 610-984-9291 3773 CORPORATE PWKY. SE DECISION MADE: 20-NOV-08 CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AIRSONNETT AIRSHOWER AIR 3 AIRSONETT, INC. 510(k) NO: K081062(TRADITIONAL)
ATTN: CONSTANCE G BUNDY PHONE NO : 763-574-1976 6470 RIVERVIEW TERRACE SE DECISION MADE: 07-NOV-08 FINDLEY, MN 55432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AERO TRACHEOBRONCHIAL STENT TECHNOLOGY SYSTEM ALVEOLUS, INC 510(k) NO: K082284(TRADITIONAL)
ATTN: TONY ALEXANDER PHONE NO : 704-926-4846 9013 PERIMETER WOODS DR. SE DECISION MADE: 20-NOV-08 SUITE A 510(k) SUMMARY AVAILABLE FROM FDA CHARLOTTE, NC 28216 DEVICE: AMCO REPLACEMENT BATTERY FOR POWERHEART AED, NON-RECHARGEABLE, M AMCO INTERNATIONAL MANUFACTURING &510(k) NO: K082861(TRADITIONAL)
ATTN: ALEXANDER B HENDERSON SR. PHONE NO : 303-646-3715 377 ZANE COURT SE DECISION MADE: 25-NOV-08 ELIZABETH, CO 80107 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH INT AMERICAN MEDICAL SYSTEMS, INC. 510(k) NO: K082730(SPECIAL)
ATTN: MONA INMAN PHONE NO : 952-930-6204 10700 BREN RD., WEST SE DECISION MADE: 26-NOV-08 MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL CLINICAL THERMOMETER MODEL V9XX AMPEROR-ELECTRONIC(SZ) CO., LTD 510(k) NO: K082266(TRADITIONAL) ATTN: LARRY YANG PHONE NO : 867 552 7475570 KU-SU VILLAGE, SHI-SHAN TOWN SE DECISION MADE: 07-NOV-08 BAOAN COUNTY 510(k) SUMMARY AVAILABLE FROM FDA SHENZHEN, GUANDONG, CHINA 518126 THIRD PARTY REVIEW DEVICE: MICRO-TOUCH NITRATEX STERILE NITRILE POWDER-FREE BLUE EXAMINATIO ANSELL HEALTHCARE PRODUCTS, INC. 510(k) NO: K082457(ABBREVIATED)
ATTN: CYNTHIA A INGRAM PHONE NO : 334-615-2563 1635 INDUSTRIAL ROAD SE DECISION MADE: 10-NOV-08 DOTHAN, AL 36303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACTIFUSE BONE GRAFT SUBSTITUTE AND E-Z-FIL AND SHAPE BONE GRAFT APATECH LTD. 510(k) NO: K081979(TRADITIONAL)
ATTN: CANDACE F CEDERMAN PHONE NO : 503-722-7494 15058 ARMEL DRIVE SE DECISION MADE: 06-NOV-08 OREGON CITY, OR 97045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACTIFUSE BONE GRAFT SUBSTITUTE AND ABX E-Z-FIL AND SHAPE BONE GR APATECH LTD. 510(k) NO: K082575(TRADITIONAL)
ATTN: CANDACE F CEDERMAN PHONE NO : 503-722-7494 15058 ARMEL DRIVE SE DECISION MADE: 25-NOV-08 OREGON CITY, OR 97045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIONEXA SINGLE AND MULTI-STRIP CASSETTE/DIPSTICK DOA SCREEN PANE APPLIED DNA TECHNOLOGIES, INC. 510(k) NO: K080467(TRADITIONAL)
ATTN: FENG YU-LEE PHONE NO : 714-624-2347 26251 VERONA PLACE SE DECISION MADE: 25-NOV-08 MISSION VIEJO, CA 92692 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AREX SCRU 2 HEADLESS COMPRESSION SCREWS, MODELS: P2P10, P2P15, P AREX USA 510(k) NO: K081011(TRADITIONAL)
ATTN: ELLEN HOKANSON PHONE NO : 610-584-6870 1335 MERRYBROOK RD. SE DECISION MADE: 07-NOV-08 COLLEGEVILLE, PA 19426 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHROCARE ARTHROWANDS ARTHROCARE CORP. 510(k) NO: K082980(SPECIAL)
ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-736-0224 680 VAQUEROS AVE. SE DECISION MADE: 05-NOV-08 SUNNYVALE, CA 94085-3523 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASAHI REGALIA XS 1.0 PERIPHERAL GUIDE WIRE, MODELS PAGP 140000 & ASAHI INTECC CO., LTD. 510(k) NO: K083146(SPECIAL)
ATTN: YOSHI TERAI PHONE NO : 949-756-8252 2500 RED HILL SUITE 210 SE DECISION MADE: 21-NOV-08 SANTA ANA,, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT ASTORIA-PACIFIC,INC. 510(k) NO: K080294(TRADITIONAL)
ATTN: JASON REYNOLDS PHONE NO : 503-657-3010 15130 S.E. 82ND DR. SE DECISION MADE: 04-NOV-08 CLACKAMAS, OR 97015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERI-LUB LUBRICATION GEL AVAIL MEDICAL PRODUCTS, INC. 510(k) NO: K083189(SPECIAL)
ATTN: PATRICIA A GOEREE PHONE NO : 949-263-5060 1900 CARNEGIE AVE. SE DECISION MADE: 21-NOV-08 SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVALON ELITE VASCULAR ACCESS KIT AVALON LABORATORIES, LLC 510(k) NO: K081940(TRADITIONAL)
ATTN: LEE WIRTH PHONE NO : 310-761-8660 2610 E. HOMESTEAD PLACE SE DECISION MADE: 18-NOV-08 RANCHO DOMINGUEZ, CA 90220 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PHOENIX INDUCIBLE MACRO BECTON, DICKINSON & CO. 510(k) NO: K082538(TRADITIONAL)
ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287 7 LOVETON CIR. SE DECISION MADE: 20-NOV-08 SPARKS, MD 21152 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: N-DEX FREE NIGHTHAWK BLACK NITRILE MEDICAL EXAMINATION GLOVE, PO BEST GLOVE, INC 510(k) NO: K082125(TRADITIONAL)
ATTN: NEIL DOW PHONE NO : 706-862-6712 579 EDISON STREET SE DECISION MADE: 21-NOV-08 MENLO, GA 30731-6335 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TELECTRODE WET GEL ECG ELECTRODE BIO PROTECH, INC. 510(k) NO: K083148(TRADITIONAL)
ATTN: KEVIN HAN PHONE NO : 82 337 357720 1720-26 TAEJANG 2-DONG, WONJU SE DECISION MADE: 07-NOV-08 WOONJU-SI, GANGWON-DO, REPUBLIC OF510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458 BIO-MEDICAL RESEARCH, LTD. 510(k) NO: K082011(TRADITIONAL)
ATTN: ANNE-MARIE KEENAN PHONE NO : 353 91 774300 PARKMORE BUSINESS PARK WEST SE DECISION MADE: 28-NOV-08 GALWAY, IRELAND 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENEX BIOCOMPOSITES LTD. 510(k) NO: K082381(TRADITIONAL)
ATTN: SIMON FITZER PHONE NO : 441 782 338580 KEELE SCIENCE PARK SE DECISION MADE: 14-NOV-08 KEELE, STAFFORDSHIRE, UNITED KINGD510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOLOK MICRO-LOK IMPLANT SYSTEM BIOHORIZONS IMPLANT SYSTEMS, INC. 510(k) NO: K081818(SPECIAL)
ATTN: MICHAEL DAVIS PHONE NO : 205-967-7880 2300 RIVERCHASE CENTER SE DECISION MADE: 13-NOV-08 BIRMINGHAM, AL 35244 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EZLASE 10W BIOLASE TECHNOLOGY, INC. 510(k) NO: K083069(SPECIAL)
ATTN: IOANA RIZOIU PHONE NO : 949-226-8144 4 CROMWELL SE DECISION MADE: 13-NOV-08 IRVINE, CA 92618-1816 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORE VISION DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM BIOPTICS, INC. 510(k) NO: K082432(TRADITIONAL)
ATTN: PATRICIA WADE PHONE NO : 623-214-0039 15546 W. GELDING DR. SE DECISION MADE: 21-NOV-08 SURPRISE, AZ 85379 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PASSEO-35 PTA CATHETER BIOTRONIK, INC. 510(k) NO: K082933(SPECIAL)
ATTN: JON BRUMBAUGH PHONE NO : 888-345-0374 6024 JEAN ROAD SE DECISION MADE: 03-NOV-08 LAKE OSWEGO, OR 97035 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BODYSTAT 1500 BODY COMPOSITION MONITORING UNIT BODYSTAT LTD. 510(k) NO: K082253(TRADITIONAL)
ATTN: I. J. MEEUWSEN PHONE NO : 44 162 4629571 PO BOX 50 SE DECISION MADE: 25-NOV-08 DOUGLAS ISLE OF MAN 510(k) SUMMARY AVAILABLE FROM FDA BRITISH ISLES, UNITED KINGDOM IM99 1DQ DEVICE: BONART ART-L5 LED CORDLESS CURING LIGHT BONART CO. LTD. 510(k) NO: K082971(TRADITIONAL)
ATTN: ERIC L ONG PHONE NO : 909-594-8066 398 S. LEMON CREEK DR. SE DECISION MADE: 13-NOV-08 STE. L 510(k) STATEMENT WALNUT, CA 91789 DEVICE: SALINE ENHANCED ELECTROSURGICAL RESECTION (SEER) DEVICE BOVIE MEDICAL 510(k) NO: K082568(TRADITIONAL)
ATTN: RICHARD A KOZLOFF PHONE NO : 727-803-8513 7100 30TH AVE. NORTH SE DECISION MADE: 17-NOV-08 ST. PETERSBURG, FL 33710-2902 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCREEN BRANAN MEDICAL CORPORATION 510(k) NO: K082508(TRADITIONAL)
ATTN: RAPHAEL WONG PHONE NO : 949-598-7166 140 TECHNOLOGY DRIVE SE DECISION MADE: 21-NOV-08 SUITE 400 510(k) SUMMARY AVAILABLE FROM FDA IRVINE, CA 92618 DEVICE: VIPERSPHERE PTA BALLOON CATHETER CARDIOVASCULAR SYSTEMS, INC. 510(k) NO: K083139(TRADITIONAL)
ATTN: DAVID BROOKE PHONE NO : 651-259-2061 651 CAMPUS DR. SE DECISION MADE: 25-NOV-08 ST. PAUL, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MYRAY SKYVIEW CEFLA S.C. 510(k) NO: K081088(ABBREVIATED)
ATTN: BERTHOIN CLAUDE PHONE NO : 386-672-0450 110 E. GRANADA BLVD. SE DECISION MADE: 06-NOV-08 SUITE 207 510(k) STATEMENT ORMOND BEACH, FL 32176 DEVICE: CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23 CIRCLE CARDIOVASCULAR IMAGING INC.510(k) NO: K082628(TRADITIONAL)
ATTN: SHIRANTHA SAMARAPPULI PHONE NO : 403 775 1857 SUITE 130, 31 STREET NW SE DECISION MADE: 20-NOV-08 CALGARY, ALBERTA, CANADA T2L 2K7 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RETCAM 3 OPHTHALMIC IMAGING SYSTEM CLARITY MEDICAL SYSTEMS 510(k) NO: K081858(TRADITIONAL) ATTN: GARY A SEEGER PHONE NO : 925-463-7984 5775 WEST LAS POSITAS BLVD. SE DECISION MADE: 05-NOV-08 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA PLEASANTON, CA 94588-4084 DEVICE: FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL CONTEC MEDICAL SYSTEM CO., LTD. 510(k) NO: K082641(SPECIAL)
ATTN: DIANA HONG PHONE NO : 862 164 264467 SUITE 8D , ZHONGXIN ZHONGSHAN SE DECISION MADE: 10-NOV-08 MANSION, NO. 19, LANE 999, 510(k) SUMMARY AVAILABLE FROM FDA ZHONG SHAN, SHANGHAI, CHINA 20030 DEVICE: TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER COOK UROLOGICAL, INC. 510(k) NO: K082066(TRADITIONAL)
ATTN: CINDY FOOTE PHONE NO : 812-829-4891 750 DANIELS WAY SE DECISION MADE: 07-NOV-08 BLOOMINGTON, IN 47404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AIR ASSISTED SPRAYER, MODELS: AIRSPRAYUS01 AND AIRSPRAYUS COVIDIEN 510(k) NO: K082322(TRADITIONAL)
ATTN: VIRGINIA VETTER PHONE NO : 781-839-1755 101A FIRST AVE SE DECISION MADE: 14-NOV-08 WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROMYST APPLICATOR, MODEL 20-5000 COVIDIEN 510(k) NO: K082454(TRADITIONAL)
ATTN: VIRGINIA VETTER PHONE NO : 781-839-1755 101A FIRST AVE SE DECISION MADE: 07-NOV-08 WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VALLEYLAB MICROWAVE ABLATION GENERATOR COVIDIEN LP, FORMERLY KNOW AS VALL510(k) NO: K072687(TRADITIONAL)
ATTN: PHILIP E AKE PHONE NO : 303-581-6934 5920 LONGBOW DR. SE DECISION MADE: 25-NOV-08 BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SILS PORT, MODELS SILSPT5, SILSPT12 COVIDIEN LP, FORMERLY REGISTERED A510(k) NO: K082619(TRADITIONAL)
ATTN: ROBERT ZOTT PHONE NO : 203-492-6013 60 MIDDLETOWN AVENUE SE DECISION MADE: 07-NOV-08 NORTH HAVEN, CT 06473 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDIO-VIEW CURLVIEW IGT, LLC 510(k) NO: K083321(TRADITIONAL)
ATTN: PHONE NO : 1242 CHESTNUT ST. SE DECISION MADE: 26-NOV-08 NEWTON, MA 02464 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: COMMISSIONING DATA MANAGEMENT SYSTEM (CDMS) D3 RADIATION PLANNING 510(k) NO: K082606(TRADITIONAL)
ATTN: NABIL ADNANI PHONE NO : 412-365-0743 5750 CENTRE AVE., SUITE 500 SE DECISION MADE: 10-NOV-08 PUTTSBURGH, PA 15206 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAPPHIRE PLASMA ARC DENTAL CURING LIGHT DEN-MAT HOLDINGS, LLC 510(k) NO: K081287(ABBREVIATED)
ATTN: ALAN MATTHEWS PHONE NO : 805-922-8491 2727 SKYWAY DR. SE DECISION MADE: 21-NOV-08 SANTA MARIA, CA 93455 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MYSTIQUE MB CERAMIC BRACKETS DENTSPLY INTERNTIONAL 510(k) NO: K082974(SPECIAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511 221 W. PHILADELPHIA ST. STE.60 SE DECISION MADE: 07-NOV-08 SUSQUEHANNA COMMERCE CRT. WEST 510(k) SUMMARY AVAILABLE FROM FDA YORK, PA 17405 DEVICE: HEALIX TI ANCHOR DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K082282(TRADITIONAL)
ATTN: KRISTINE CHRISTO PHONE NO : 508-828-3359 325 PARAMOUNT DRIVE SE DECISION MADE: 07-NOV-08 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEPUY SIGMA CR-F FEMORAL COMPONENT DEPUY ORTHOPAEDICS, INC. 510(k) NO: K082500(TRADITIONAL)
ATTN: NANCY FRIDDLE PHONE NO : 574-371-4923 700 ORTHOPAEDIC DR. SE DECISION MADE: 18-NOV-08 WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEPUY SPINE LATERAL CAGE SYSTEM DEPUY SPINE 510(k) NO: K082128(TRADITIONAL)
ATTN: DENISE DUCHENE PHONE NO : 508-880-8074 325 PARAMOUNT DR. SE DECISION MADE: 14-NOV-08 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIASORIN LIASON RUBELLA IGG ASSAY; DIASORIN LIAISON RUBELLA IGG DIASORIN, INC. 510(k) NO: K073390(TRADITIONAL)
ATTN: MARI MEYER PHONE NO : 651-351-5635 1951 NORTHWESTERN AVE. SE DECISION MADE: 21-NOV-08 P.O. BOX 285 510(k) SUMMARY AVAILABLE FROM FDA STILLWATER, MN 55082-0285 DEVICE: LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG DIASORIN, INC. 510(k) NO: K081685(TRADITIONAL)
ATTN: CAROL A DEPOUW PHONE NO : 651-351-5850 1951 NORTHWESTERN AVE. SE DECISION MADE: 18-NOV-08 P.O. BOX 285 510(k) SUMMARY AVAILABLE FROM FDA STILLWATER, MN 55082-0285 DEVICE: LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG DIASORIN, INC. 510(k) NO: K081687(TRADITIONAL)
ATTN: CAROL A DEPOUW PHONE NO : 651-351-5850 1951 NORTHWESTERN AVE. SE DECISION MADE: 10-NOV-08 P.O. BOX 285 510(k) SUMMARY AVAILABLE FROM FDA STILLWATER, MN 55082-0285 DEVICE: LIAISON HAV IGM ASSAY, LIAISON CONTROL HAV IGM DIASORIN, INC. 510(k) NO: K082050(TRADITIONAL)
ATTN: CAROL A DEPOUW PHONE NO : 651-351-5850 1951 NORTHWESTERN AVE. SE DECISION MADE: 03-NOV-08 P.O. BOX 285 510(k) SUMMARY AVAILABLE FROM FDA STILLWATER, MN 55082-0285 DEVICE: DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B DIAZYME LABORATORIES 510(k) NO: K082763(SPECIAL)
ATTN: ABHIJIT DATTA PHONE NO : 858-455-4762 12889 GREGG COURT SE DECISION MADE: 12-NOV-08 POWAY, CA 92064 510(k) STATEMENT DEVICE: INTELLIGENT DOSING SYSTEM FOR INSULIN-MY INSULIN DOSER DIMENSIONAL DOSING SYSTEMS, INC. 510(k) NO: K082512(TRADITIONAL)
ATTN: EJ SMITH PHONE NO : 410-451-0639 1468 HARWELL AVE SE DECISION MADE: 07-NOV-08 CROFTON, MD 21114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OXYLOG 2000 PLUS SYSTEM (MODEL 5705080), OXYLOG 2000 PLUS BASIC DRAEGER MEDICAL B.V. 510(k) NO: K082600(TRADITIONAL)
ATTN: JOYCE KILROY PHONE NO : 215-721-5400 3135 QUARRY ROAD SE DECISION MADE: 26-NOV-08 TELFORD, PA 18969 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INFINITY NELLCOR OXIMAX SMARTPOD, MODEL MS23997 DRAEGER MEDICAL SYSTEMS, INC. 510(k) NO: K082888(SPECIAL)
ATTN: PRADEEP GUPTA PHONE NO : 978-379-8219 6 TECH DRIVE SE DECISION MADE: 26-NOV-08 ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DXRAD MODELS DX800 OR DX808 DIGITAL DIAGNOSTIC RADIOGRAPHIC SYST DXRAD SOLUTIONS LTD. 510(k) NO: K082261(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854 PO BOX 7007 SE DECISION MADE: 06-NOV-08 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOMET ANTERIOR LUMBAR PLATE EBI, L.P. 510(k) NO: K082187(TRADITIONAL)
ATTN: VIVIAN KELLY MS, RAC PHONE NO : 973-299-9300 100 INTERPACE PKWY. SE DECISION MADE: 13-NOV-08 PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR EDAN INSTRUMENTS, INC. 510(k) NO: K082369(SPECIAL)
ATTN: WILLIAM STERN PHONE NO : 914-376-5200 1 ODELL PLAZA SE DECISION MADE: 07-NOV-08 YONKERS, NY 10701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FETAL & MATERNAL MONITOR, MODEL F6, F9 EDAN INSTRUMENTS, INC. 510(k) NO: K082602(TRADITIONAL)
ATTN: WILLIAM STERN PHONE NO : 914-376-5200 1 ODELL PLAZA SE DECISION MADE: 26-NOV-08 YONKERS, NY 10701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMG TRITON -COMP,MODEL NCA01-XXX SERIES EMG TECHNOLOGY CO., LTD. 510(k) NO: K072634(TRADITIONAL)
ATTN: SALLY CHUANG PHONE NO : 042 359 6033 4F-2, NO. 210, 38 RD. SE DECISION MADE: 19-NOV-08 TAICHUNG INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA SHITUEN CHIU, TAICHUNG, CHINA (TAITHIRD PARTY REVIEW DEVICE: BIOLOX DELTA CERAMIC FEMORAL HEAD, BIOLOX DELTA CERAMIC FEMORAL ENCORE MEDICAL, L.P. 510(k) NO: K082844(SPECIAL)
ATTN: TEFFANY HUTTO PHONE NO : 512-834-6255 9800 METRIC BLVD. SE DECISION MADE: 25-NOV-08 AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENABLER-P SUPPORT CATHETER ENDOCROSS, LTD. 510(k) NO: K082339(TRADITIONAL)
ATTN: JOHN J SMITH PHONE NO : 202-637-3638 555 THIRTEENTH STREET NW SE DECISION MADE: 20-NOV-08 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/- ENVITEC-WISMAR GMBH 510(k) NO: K082655(TRADITIONAL)
ATTN: STEPHEN GORSKI PHONE NO : 262-594-2114 S65 W35739 PIPER ROAD SE DECISION MADE: 25-NOV-08 EAGLE, WI 53119 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EVERCROSS .035 OTW PTA DILATATION CATHETER EV3 INC. 510(k) NO: K082579(TRADITIONAL)
ATTN: DAVID WORRELL PHONE NO : 763-398-7344 4600 NATHAN LN. NORTH SE DECISION MADE: 20-NOV-08 PLYMOUTH, MN 55442-2920 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TABATABA COTESTER FIM MEDICAL 510(k) NO: K080278(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854 PO BOX 7007 SE DECISION MADE: 28-NOV-08 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POGO SCREW FXDEVICES 510(k) NO: K080649(TRADITIONAL)
ATTN: RICH LIPSCHUTZ PHONE NO : 561-394-6501 ONE SOUTH OCEAN BLVD. SE DECISION MADE: 25-NOV-08 BOCA RATON, FL 33432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GDLS-200 GC AMERICA, INC. 510(k) NO: K082434(TRADITIONAL)
ATTN: MARK HEISS PHONE NO : 708-897-4042 3737 WEST 127TH ST. SE DECISION MADE: 14-NOV-08 ALSIP, IL 60803 510(k) STATEMENT DEVICE: GC AADVA ZR DISK GC AMERICA, INC. 510(k) NO: K082740(SPECIAL)
ATTN: MARK HEISS PHONE NO : 708-597-0900 3737 WEST 127TH ST. SE DECISION MADE: 26-NOV-08 ALSIP, IL 60803 510(k) STATEMENT DEVICE: GE ENTROPY SENSOR GE HEALTHCARE 510(k) NO: K082540(TRADITIONAL)
ATTN: JOEL C KENT PHONE NO : 781-449-8685 86 PILGRIM ROAD SE DECISION MADE: 28-NOV-08 NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CENTRICITY PACS WEB DIAGNOSTIC GE HEALTHCARE DYNAMIC IMAGING SOLU510(k) NO: K083018(SPECIAL)
ATTN: JILLIAN M REED PHONE NO : 201-934-8644 25 WALNUT ST. SE DECISION MADE: 14-NOV-08 MONROE, CT 06468 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULTLINK CABLE AND LEADWIRE SYSTEM GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K082851(TRADITIONAL)
ATTN: MATTHIAS BUERGER PHONE NO : 414-721-1438 9900 INNOVATION DR. SE DECISION MADE: 19-NOV-08 RP-2122 510(k) SUMMARY AVAILABLE FROM FDA WAUWATOSA, WI 53226 DEVICE: GE LUNAR FEMUR STRENGTH SOFTWARE GE MEDICAL SYSTEMS ULTRASOUND AND 510(k) NO: K072664(TRADITIONAL)
ATTN: JAMES RASKOB PHONE NO : 608-826-7425 726 HEARTLAND TRAIL SE DECISION MADE: 21-NOV-08 MADISON, WI 53717 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISCOVERY MR450 GE MEDICAL SYSTEMS, LLC 510(k) NO: K083147(TRADITIONAL)
ATTN: YUAN MA PHONE NO : 262-521-6223 3200 N. GRANDVIEW BLVD. SE DECISION MADE: 04-NOV-08 WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PRECISION RXI ANALOG AND DIGITAL X-RAY SYSTEMS GENERAL MEDICAL MERATE S.P.A. 510(k) NO: K082243(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412 5401 S. COTTONWOOD COURT SE DECISION MADE: 07-NOV-08 GREENWOOD VILLAGE, CO 80121 510(k) STATEMENT DEVICE: FACTOR VIII ANTIBODY SCREEN GENETIC TESTING INSTITUTE 510(k) NO: K082205(TRADITIONAL)
ATTN: MICHELLE A STAPLETON PHONE NO : 262-754-1065 20925 CROSSROADS CIRCLE SE DECISION MADE: 20-NOV-08 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA WAUKESHA, WI 53186-4054 DEVICE: PROTEX CT CERVICOTHORACIC SPINAL SYSTEM GLOBUS MEDICAL, INC. 510(k) NO: K081906(SPECIAL)
ATTN: KELLY J BAKER PHONE NO : 610-415-9000 2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 14-NOV-08 VALLEY FORGE BUSINESS CENTER 510(k) SUMMARY AVAILABLE FROM FDA AUDUBON, PA 19403 DEVICE: INDEPENDENCE SPACER GLOBUS MEDICAL, INC. 510(k) NO: K082252(TRADITIONAL)
ATTN: KELLY BAKER PHONE NO : 610-415-9000 2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 05-NOV-08 VALLEY FORGE BUSINESS CENTER 510(k) SUMMARY AVAILABLE FROM FDA AUDUBON, PA 19403 DEVICE: RHAPSODY CT GRANTADLER CORPORATION 510(k) NO: K081889(TRADITIONAL)
ATTN: ARTHUR WARD PHONE NO : 813-645-2855 962 ALLEGRO LANE SE DECISION MADE: 12-NOV-08 APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RHAPSODY MRI GRANTADLER CORPORATION 510(k) NO: K082126(TRADITIONAL)
ATTN: ARTHUR WARD PHONE NO : 813-645-2855 962 ALLEGRO LANE SE DECISION MADE: 13-NOV-08 APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IDI IMPLANT SYSTEM IDI BIOMEDICAL LLC 510(k) NO: K081806(TRADITIONAL)
ATTN: ANGELA BLACKWELL PHONE NO : 704-450-9934 104 2ND ST. SE SE DECISION MADE: 07-NOV-08 CATAWBA, NC 28609 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INFINITT CARDIOLOGY PACS INFINITT CO., LTD. 510(k) NO: K082706(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 940-300-8601 1600 MANCHESTER WAY SE DECISION MADE: 06-NOV-08 CORINTH, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: INFINITT XELIS INFINITT CO., LTD. 510(k) NO: K082990(TRADITIONAL)
ATTN: TRISTAN CHOI PHONE NO : 82 2 21946673 12F DAERUNG POST TOWER III SE DECISION MADE: 20-NOV-08 182-4 GURO-DONG, GURO-GU 510(k) SUMMARY AVAILABLE FROM FDA SEOUL, REPUBLIC OF KOREA 152-050 THIRD PARTY REVIEW DEVICE: OSV II INTEGRA NEUROSCIENCES IMPLANTS S.A510(k) NO: K081773(SPECIAL)
ATTN: JON CAPAROTTA PHONE NO : 609-936-2495 311 ENTERPRISE DRIVE SE DECISION MADE: 06-NOV-08 PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO INTEL HEALTH GUIDE, MODEL PHS6000 INTEL CORP. 510(k) NO: K083115(SPECIAL)
ATTN: TAE-WOONG KOO PHONE NO : 408-765-2060 1900 PRAIRIE CITY RD., FM7-197 SE DECISION MADE: 26-NOV-08 FOLSOM, CA 95630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LEP2000 THERAPY SYSTEM INTERNATIONAL MEDICAL INSTRUMENTS,510(k) NO: K073689(TRADITIONAL)
ATTN: M. JOYCE HEINRICH PHONE NO : 713-734-4433 12101 CULLEN BLVD. SE DECISION MADE: 13-NOV-08 SUITE A 510(k) STATEMENT HOUSTON, TX 77047 DEVICE: HRK-63-16 KNEE ARRAY COIL, HRK-127-16 KNEE ARRAY COIL INVIVO 510(k) NO: K082987(SPECIAL)
ATTN: ANDREW ADAMS PHONE NO : 352-336-0010 3545 S.W. 47TH AVE. SE DECISION MADE: 06-NOV-08 GAINESVILLE, FL 32608 510(k) STATEMENT DEVICE: DYN-ALIF ANTEROLATERAL INTERVERTEBRAL BODY FUSION DEVICE IONICS MEDICAL CORP. 510(k) NO: K081673(ABBREVIATED)
ATTN: M. LAINE MASHBUM PHONE NO : 910-428-9726 248 BIRD HAVEN LN. SE DECISION MADE: 14-NOV-08 ETHER, NC 27247-0179 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODEL ES-130 ITO CO., LTD. 510(k) NO: K081943(TRADITIONAL)
ATTN: KENNETH L BLOCK PHONE NO : 972-480-9554 1201 RICHARDSON DR., SUITE 140 SE DECISION MADE: 24-NOV-08 RICHARDSON, TX 75080 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JARIT HULKA UTERINE TENACULUM FORCEPS J. JAMNER SURGICAL INSTRUMENTS, IN510(k) NO: K082349(TRADITIONAL)
ATTN: JENNIFER BOSLEY PHONE NO : 717-781-6392 589 DAVIES DRIVE SE DECISION MADE: 21-NOV-08 YORK, PA 17402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODE JAS DIAGNOSTICS, INC. 510(k) NO: K080623(TRADITIONAL)
ATTN: SAMUEL BURGOS PHONE NO : 305-418-2320 7220 NW 58TH ST. SE DECISION MADE: 17-NOV-08 MIAMI, FL 33166 510(k) STATEMENT DEVICE: THORACOLUMBAR, LUMBAR AND SACRAL PLATES AND 6.0 AND 7.0 MM BONE K2M, INC. 510(k) NO: K081380(TRADITIONAL)
ATTN: RICHARD W WOODS PHONE NO : 703-777-3155 751 MILLER DR.,S.E., SUITE F1 SE DECISION MADE: 19-NOV-08 LEESBURG, VA 20175 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL RADIOGRAPHY, FLEXDR C30 KONICA MINOLTA TECHNOPRODUCT CO., 510(k) NO: K082347(TRADITIONAL)
ATTN: RUSSEL MUNVES PHONE NO : 212-490-4100 140 EAST 45TH ST., 25TH FL. SE DECISION MADE: 18-NOV-08 TWO GRAND CENTRAL TOWER 510(k) SUMMARY AVAILABLE FROM FDA NEW YORK, NY 10017 DEVICE: LANG DENTAL ACRYLIC PRIMER LANG DENTAL MFG. CO., INC. 510(k) NO: K081981(TRADITIONAL)
ATTN: CHAH M SHEN PHONE NO : 847-215-6622 175 MESSNER DR. SE DECISION MADE: 17-NOV-08 WHEELING, IL 60090-0969 510(k) STATEMENT DEVICE: DPL THERAPY SYSTEM LED TECHNOLOGIES, LLC 510(k) NO: K081570(TRADITIONAL)
ATTN: LEWIS WARD PHONE NO : 303-530-3279 4655 KIRKWOOD COURT SE DECISION MADE: 07-NOV-08 BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LEVITRONIX CENTRIMAG PRIMARY CONSOLE; THORATEC CANTRIMAG PRIMARY LEVITRONIX LLC. 510(k) NO: K083340(SPECIAL)
ATTN: SUSAN HAMANN PHONE NO : 781-466-6553 45 FIRST AVE. SE DECISION MADE: 26-NOV-08 WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANORECTAL MANOMETRY SOFTWARE OPTION ARM-1 LIFE-TECH, INC. 510(k) NO: K082056(TRADITIONAL)
ATTN: JEFF KASOFF PHONE NO : 281-491-6600 4235 GREENBRIAR DR. SE DECISION MADE: 07-NOV-08 STAFFORD, TX 77477-3995 510(k) STATEMENT DEVICE: LTM-BPS SURGICAL MESH LIFECELL CORP. 510(k) NO: K082176(TRADITIONAL)
ATTN: LORRAINE T MONTEMURRO PHONE NO : 908-947-1115 ONE MILLENNIUM WAY SE DECISION MADE: 14-NOV-08 BRANCHBURG, NJ 08876 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FIBERNET EMBOLIC PROTECTION SYSTEM LUMEN BIOMEDICAL, INC. 510(k) NO: K082348(TRADITIONAL)
ATTN: MARIA E BRITTLE PHONE NO : 763-746-9550 14505 21ST AVE. NORTH SE DECISION MADE: 18-NOV-08 SUITE 212 510(k) SUMMARY AVAILABLE FROM FDA PLYMOUTH, MN 55447 DEVICE: MAJOR.REPAIR MAJOR PRODOTTI DENTARI S.P.A. 510(k) NO: K082153(TRADITIONAL)
ATTN: MONICA FUNAI PHONE NO : 39 011 6400211 VIA LUIGI EINAUDI 23 SE DECISION MADE: 25-NOV-08 MONACALIERI (TORINO), ITALY I-1002510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAKO SURGICAL TACTILE GUIDANCE SYSTEM VERSION 2.0 MAKO SURGICAL CORP. 510(k) NO: K081867(TRADITIONAL)
ATTN: WILLIAM TAPIA PHONE NO : 954-927-2044 2555 DAVIE RD. SE DECISION MADE: 25-NOV-08 FORT LAUDERDALE, FL 33317 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM MAKO SURGICAL CORPORATION 510(k) NO: K082172(TRADITIONAL)
ATTN: WILLIAM F TAPIA PHONE NO : 954-927-2044 2555 DAVIE ROAD SE DECISION MADE: 28-NOV-08 FORT LAUDERDALE, FL 33317 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENOUS BUBBLE TRAP, MODEL VBT 160; VENOUS BUBBLE TRAP WITH BIOLI MAPQUET CARDIOPULMONARY AG 510(k) NO: K082412(TRADITIONAL)
ATTN: KATRIN SCHWENKGLENKS PHONE NO : 011 497 478921151 HECHINGER STRASSE 38 SE DECISION MADE: 10-NOV-08 HIRRLINGEN, GERMANY 72145 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEALTHLINE MEDICATOR / REDINEB AEROSOL DRUG DELIVERY SYSTEM MEDI NUCLEAR CORP., INC. 510(k) NO: K082541(TRADITIONAL)
ATTN: JERRY SCHOEN PHONE NO : 626-960-9822 4610 LITTLEJOHN ST. SE DECISION MADE: 26-NOV-08 BALDWIN PARK, CA 91706 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT MEDICA CORP. 510(k) NO: K080823(TRADITIONAL)
ATTN: PHOTIOS MAKRIS PHONE NO : 781-275-4892 5 OAK PARK DRIVE SE DECISION MADE: 17-NOV-08 BEDFORD, MA 01730 510(k) STATEMENT DEVICE: THERAGEM PROFESSIONAL T1002 MEDICA HEALTH, LTD 510(k) NO: K081505(TRADITIONAL)
ATTN: TERRI CMOREY PHONE NO : 954-725-6493 2842 KELLY BROOKE LANE SE DECISION MADE: 19-NOV-08 DEERFIELD BEACH, FL 33442 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT A MEDTRONIC NEUROSURGERY 510(k) NO: K083076(SPECIAL)
ATTN: JEFFREY HENDERSON PHONE NO : 805-571-8445 125 CREMONA DR. SE DECISION MADE: 20-NOV-08 GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K081080(TRADITIONAL)
ATTN: MELISA LANSKY PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 21-NOV-08 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROGENIX PLUS MEDTRONIC SOFAMOR DANEK 510(k) NO: K082002(TRADITIONAL)
ATTN: MICHELLE OBENAUER PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 24-NOV-08 MEMPHIS, TN 38132-3576 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROGENIX MEDTRONIC SOFAMOR DANEK 510(k) NO: K082463(TRADITIONAL)
ATTN: RYAN MASSEY PHONE NO : 901-396-3133 PYRAMID PLACE SE DECISION MADE: 10-NOV-08 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K083071(SPECIAL)
ATTN: MELISA LANSKY PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 14-NOV-08 MEMPHIS, TN 38132-3576 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C-QUEST MEDX, INC. 510(k) NO: K082581(TRADITIONAL)
ATTN: WILLIAM GREENROSE PHONE NO : 603-369-3550 220 RIVER ROAD SE DECISION MADE: 14-NOV-08 CLAREMONT, NH 03743 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MO MICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K082881(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 949-429-5825 55 NORTHERN BOULEVARD SE DECISION MADE: 24-NOV-08 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA GREAT NECK, NY 10021 DEVICE: CLEAR-VU SYSTEM, MODELS: CVL-01-1000, CVL-01-1030, CVL-01-1045 MINIMALLY INVASIVE DEVICES LLC 510(k) NO: K080613(TRADITIONAL)
ATTN: MICHAEL H SOUTHWORTH PHONE NO : 216-287-0312 1035 WALDO WAY SE DECISION MADE: 06-NOV-08 TWINSBURG, OH 44087 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MINXRAY, MODEL CMDR-1S AND CMDR-1S-MIL MINXRAY, INC. 510(k) NO: K082627(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854 P.O. BOX 7007 SE DECISION MADE: 07-NOV-08 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPONENT NEUROMONITORING SYSTEM MOBERG RESEARCH, INC. 510(k) NO: K080217(TRADITIONAL)
ATTN: DAMON LEES PHONE NO : 215-283-0860 224 S. MAPLE WAY SE DECISION MADE: 05-NOV-08 AMBLER, PA 19002 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: STEREO NAVIGATOR ACCESSORY, STN-1000 NAVISCAN PET SYSTEMS 510(k) NO: K082354(TRADITIONAL)
ATTN: HEATHER JALISI PHONE NO : 858-332-0942 11180 ROSELLE ST, STE 100 SE DECISION MADE: 18-NOV-08 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEXUS I.V. FLUID TRANSFER DEVICE NEXUS MEDICAL, LLC 510(k) NO: K080976(TRADITIONAL)
ATTN: LARRY SMITH PHONE NO : 913-451-2234 11315 STRANG LINE ROAD SE DECISION MADE: 10-NOV-08 LENEXA, KS 66215 510(k) STATEMENT DEVICE: NEXUS I.V. NEEDLESS ACCESS CANNULA FOR INTRAVASCULAR ADMINISTRAT NEXUS MEDICAL, LLC 510(k) NO: K081123(TRADITIONAL)
ATTN: LARRY SMITH PHONE NO : 913-451-2234 11315 STRANG LINE ROAD SE DECISION MADE: 14-NOV-08 LENEXA, KS 66215 510(k) STATEMENT DEVICE: NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES NIHON KOHDEN AMERICA, INC. 510(k) NO: K082785(SPECIAL)
ATTN: JACK COGGAN PHONE NO : 949-580-1555 90 ICON ST. SE DECISION MADE: 26-NOV-08 FOOTHILL RANCH, CA 92610-1601 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MOLAR IMPLANT NOBEL BIOCARE AB 510(k) NO: K081128(TRADITIONAL)
ATTN: THUONG NGUYEN SON PHONE NO : 714-282-4800 22715 SAVI RANCH PARKWAY SE DECISION MADE: 07-NOV-08 YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GOLDADAPT NON-ENGAGING NOBELACTIVE NP & RP, GOLDADAPT ENGAGING N NOBEL BIOCARE USA, LLC 510(k) NO: K083100(TRADITIONAL)
ATTN: HERBERT CRANE PHONE NO : 714-282-4800 22715 SAVI RANCH PKWY. SE DECISION MADE: 19-NOV-08 YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NORDICICE SOFTWARE NORDICIMAGINGLAB AS 510(k) NO: K082441(TRADITIONAL)
ATTN: STIAN SCISLY SAGEVIK PHONE NO : 475 570 7095 MOLLENDALSVEIEN 65C SE DECISION MADE: 21-NOV-08 BERGEN, NORWAY 5009 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOX T3, NOXTURNAL (PC APPLICATION) NOX MEDICAL 510(k) NO: K082113(TRADITIONAL)
ATTN: KOLBRUN E OTTOSDOTTIR PHONE NO : 354 522 9000 KELDNAHOLTI SE DECISION MADE: 07-NOV-08 REYKJAVIK, ICELAND 112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ONCENTRA RT VIEWER 1.0 NUCLETRON CORPORATION 510(k) NO: K082642(TRADITIONAL)
ATTN: LISA DIMMICK PHONE NO : 443-545-2196 8671 ROBERT FULTON DR. SE DECISION MADE: 07-NOV-08 COLUMBIA, MD 21046 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MODIFICATION TO: NUVASIVE SPHERX II SYSTEM NUVASIVE, INC. 510(k) NO: K083028(SPECIAL)
ATTN: HAN FAN PHONE NO : 858-909-1868 7475 LUSK BLVD SE DECISION MADE: 13-NOV-08 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OLYMPUS CHF TYPE V OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K081456(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 484-896-5688 3500 CORPORATE PARKWAY SE DECISION MADE: 06-NOV-08 PO BOX 610 510(k) SUMMARY AVAILABLE FROM FDA CENTER VALLEY, PA 18034-0610 DEVICE: TRACHEAL INTUBATION FIBERVIDEOSCOPE, MODELS LF-Y0004 AND LF-Y000 OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K082720(TRADITIONAL)
ATTN: STACY ABBATIELLO KLUESNER PHONE NO : 484-896-5405 3500 CORPORATE PARKWAY SE DECISION MADE: 05-NOV-08 PO BOX 610 510(k) SUMMARY AVAILABLE FROM FDA CENTER VALLEY, PA 18034-0610 DEVICE: SPECTRAL OCT/SLO OPKO HEALTH, INC. 510(k) NO: K080460(TRADITIONAL)
ATTN: JANE HSIAO PHONE NO : 305-575-6004 4400 BISCAYNE BLVD. SE DECISION MADE: 14-NOV-08 MIAMI, FL 33137 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORLUS MINI SCREW ORTHOLUTION CO., LTD. 510(k) NO: K082838(SPECIAL)
ATTN: CATHRYN CAMBRIA PHONE NO : 770-396-5909 5536 TROWBRIDGE DRIVE SE DECISION MADE: 25-NOV-08 DUNWOODY, GA 30338 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHOPEDIATRICS BONE SCREWS ORTHOPEDIATRICS, CORP. 510(k) NO: K082949(TRADITIONAL)
ATTN: GARY BARNETT PHONE NO : 574-268-6379 210 N. BUFFALO ST. SE DECISION MADE: 25-NOV-08 WARSAW, IN 46580 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITOSS BONE GRAFT SUBSTITUTE, BONE GRAFT SUBSTITUTE FILLED CANIS ORTHOVITA, INC. 510(k) NO: K083033(SPECIAL)
ATTN: DEBORAH L JACKSON PHONE NO : 610-640-1775 45 GREAT VALLEY PKWY. SE DECISION MADE: 06-NOV-08 MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE OSCOR INC. 510(k) NO: K081986(TRADITIONAL)
ATTN: MILA DOSKOCIL PHONE NO : 727-937-2511 3816 DE SOTO BLVD. SE DECISION MADE: 14-NOV-08 PALM HARBOR, FL 34683 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OBC BONE ANCHORED HEARING AID SYSTEM OTICON MEDICAL AB 510(k) NO: K082108(TRADITIONAL)
ATTN: KAROLIN ISBERG PHONE NO : 46 31 7486153 EKONOMIV 2 SE DECISION MADE: 14-NOV-08 GOTHENBURG, ASKIM, SWEDEN SE-436 3510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IC-PRO SYSTEM, VERSION 3.1.0.4 PAIEON, INC. 510(k) NO: K082907(TRADITIONAL)
ATTN: SHAHAR MANDELBOIM PHONE NO : 972 391 50000 22 HAMELACHA ST., P.O.B. 11355 SE DECISION MADE: 18-NOV-08 ROSH HAAYIN, ISRAEL 48901 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DDS STABILIZATION SYSTEM PARADIGM SPINE, LLC 510(k) NO: K080241(TRADITIONAL)
ATTN: JUSTIN EGGLETON PHONE NO : 202-552-5800 1331 H STREET NW SE DECISION MADE: 28-NOV-08 12TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20005 DEVICE: NEURON SELECT CATHETER SIZE 070 PENUMBRA, INC. 510(k) NO: K083125(SPECIAL)
ATTN: THERESA BRANDNER-ALLEN PHONE NO : 510-748-3223 1351 HARBOR BAY PKWY. SE DECISION MADE: 21-NOV-08 ALAMEDA, CA 94502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - CO PERCUTANEOUS SYSTEMS, INC. 510(k) NO: K082803(TRADITIONAL)
ATTN: THOMAS LAWSON PHONE NO : 650-493-4200 3260 HILLVIEW AVE. SE DECISION MADE: 13-NOV-08 PALO ALTO, CA 94304 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TANDA SKINCARE SYSTEM, MODEL: PTSCS PHAROS LIFE CORPORATION 510(k) NO: K080591(TRADITIONAL)
ATTN: PHIL CUSCUNA PHONE NO : 519 651 1177 11-380 JAMIESON PKWY SE DECISION MADE: 14-NOV-08 CAMBRIDGE, CANADA N3C 4N4 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHILIPS INTELLIVUE MP5 PATIENT MONITOR PHILIPS MEDIZIN SYSTEME BOBLINGEN 510(k) NO: K083228(SPECIAL)
ATTN: JENS-PETER SEHER PHONE NO : 497 031 4632086 HEWLETT-PACKARD-STR. 2 SE DECISION MADE: 24-NOV-08 BOBLINGEN, GERMANY D-71034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEORAY DR 2520 DIGITAL IMAGING SYSTEM PORTAVISION MEDICAL LLC 510(k) NO: K083048(TRADITIONAL)
ATTN: TERRY ANCAR PHONE NO : 866-783-4133 5401 COCOS PLUMOSAS DRIVE SE DECISION MADE: 21-NOV-08 KENNER, LA 70065 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TDS ABUTMENT POU YU BIOTECHNOLOGY CO., LTD. 510(k) NO: K081460(TRADITIONAL)
ATTN: LINDA K SCHULZ PHONE NO : 858-792-1235 11234 EL CAMINO REAL SE DECISION MADE: 21-NOV-08 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92130 DEVICE: PRODIGY NPWT SYSTEM PREMCO MEDICAL SYSTEMS, INC. 510(k) NO: K082415(TRADITIONAL)
ATTN: HAROLD JACOBS PHONE NO : 914-632-3988 699 MAIN STREET SE DECISION MADE: 25-NOV-08 NEW ROCHELLE, NY 10801 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: PRO HMPV+ ASSAY PRODESSE, INC. 510(k) NO: K082688(TRADITIONAL)
ATTN: KAREN HARRINGTON PHONE NO : 262-446-0700 W229 N 1870 WESTWOOD DR. SE DECISION MADE: 07-NOV-08 WAUKESHA, WI 53186 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SNTRYPACS QSTAR TECHNOLOGIES, INC. 510(k) NO: K082240(TRADITIONAL)
ATTN: HERMAN OOSTERWIJK PHONE NO : 940-300-8601 1600 MANCHESTER WAY SE DECISION MADE: 20-NOV-08 CORINTH, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 1.5T ATLAS SPEEDER HEAD-NECK COIL QUALITY ELECTRODYNAMICS 510(k) NO: K083160(TRADITIONAL)
ATTN: PHONE NO : 777 BETA DR. SE DECISION MADE: 07-NOV-08 MAYFIELD VILLAGE, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: QUANTA BLOOD PRESSURE METER, MODEL: CARDIAC ELITE 1000 OR QH200 QUANTA COMPUTER INC. 510(k) NO: K083078(TRADITIONAL)
ATTN: JENNIFER REICH PHONE NO : 928-773-9488 2904 N. BOLDT DR. SE DECISION MADE: 26-NOV-08 FLAGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRAWAVE III EX 1320 QUANTA SYSTEM, S.P.A. 510(k) NO: K083207(TRADITIONAL)
ATTN: ISABELLA CARRER PHONE NO : 390 331 37679 VIA IV NOVEMBRE,116 SE DECISION MADE: 14-NOV-08 SOLBIATE OLONA(VA), ITALY 21058 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: QV-9000 UNIVERSAL SYSTEM QUANTUM MEDICAL IMAGING, LLC. 510(k) NO: K083181(SPECIAL)
ATTN: MARK CAMIRAND PHONE NO : 631-619-9441 2002-B ORVILLE DRIVE NORTH SE DECISION MADE: 26-NOV-08 RONKONKOMA, NY 11779-7661 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 16CH AI BREAST COILS 1.5 T AND 3 T RAPID BIOMEDICAL GMBH 510(k) NO: K083255(TRADITIONAL)
ATTN: ARMIN PUREA PHONE NO : 49 936 588260 KETTELERSTRASSE 3-11 SE DECISION MADE: 21-NOV-08 RIMPAR, BAYERN, GERMANY 97222 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ISOELASTICU REMI SCIENCES, INC. 510(k) NO: K081025(TRADITIONAL)
ATTN: SANJIV H NAIDU PHONE NO : 717-569-7413 745 BENT CREEK DRIVE SE DECISION MADE: 21-NOV-08 LITITZ, PA 17543 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENTERAL ONLY EXTENSION SET RESPIRONICS, INC. 510(k) NO: K082654(TRADITIONAL)
ATTN: ANDREW P ZELTWANGER PHONE NO : 724-387-4120 1740 GOLDEN MILE HIGHWAY SE DECISION MADE: 25-NOV-08 MONROEVILLE, PA 15146 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VANISHPOINT I.V. CATHETER RETRACTABLE TECHNOLOGIES, INC. 510(k) NO: K081420(ABBREVIATED)
ATTN: RHONDA WELLS PHONE NO : 972-294-1010 511 LOBO LN. SE DECISION MADE: 07-NOV-08 LITTLE ELM, TX 75068-0009 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REXASTOM ORAL EASE REXADERM, INC. 510(k) NO: K082553(TRADITIONAL)
ATTN: CLYDE R GOODHEART PHONE NO : 847-562-0146 3156 DOOLITTLE DR. SE DECISION MADE: 21-NOV-08 NORTHBROOK, IL 60062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LS FAMILY OF CO2 LASERS WITH SCANNING HANDPIECE SANDSTONE MEDICAL TECHNOLOGIES, LL510(k) NO: K082101(TRADITIONAL)
ATTN: MARK ROHRER PHONE NO : 205-290-8251 105 CITATION COURT SE DECISION MADE: 05-NOV-08 HOMEWOOD, AL 35209 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HOLLYWOOD, PACIFICA, REDONDO, VENTURA SEASPINE, INC. 510(k) NO: K082310(TRADITIONAL)
ATTN: JEFF BRITTAN PHONE NO : 760-727-8399 2302 LA MIRADA DR. SE DECISION MADE: 10-NOV-08 VISTA, CA 92081-7862 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SERISCAFFOLD SURGICAL MESH SERICA TECHNOLOGIES, INC. 510(k) NO: K080442(TRADITIONAL)
ATTN: CONNIE H GARRISON PHONE NO : 781-395-5552 200 BOSTON AVENUE SE DECISION MADE: 13-NOV-08 SUITE 3700 510(k) SUMMARY AVAILABLE FROM FDA MEDFORD, MA 02155 DEVICE: BEAMAX/ FORMAX PULSED LIGHT DEVICE FAMILY SHARPLIGHT TECHNOLOGIES LTD. 510(k) NO: K082876(TRADITIONAL)
ATTN: ILAN SHARON PHONE NO : 972 528 704904 29B BEN GURION ST. SE DECISION MADE: 10-NOV-08 ZICHRON YAACOV, ISRAEL 30900 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SI JOINT FUSION SYSTEM SI-BONE, INC. 510(k) NO: K080398(TRADITIONAL)
ATTN: JEFFERY DUNN PHONE NO : 408-718-9027 15370 PEPPER LANE SE DECISION MADE: 26-NOV-08 SARATOGA, CA 95070 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM SICEL TECHNOLOGIES, INC. 510(k) NO: K083035(SPECIAL)
ATTN: SUZANNE SCHWALLER PHONE NO : 919-465-2236 3800 GATEWAY CENTRE BLVD. SE DECISION MADE: 13-NOV-08 SUITE 308 510(k) SUMMARY AVAILABLE FROM FDA MORRISVILLE, NC 27560 DEVICE: SYNGO IMAGING XS SIEMENS AG, MEDICAL SOLUTIONS 510(k) NO: K082430(TRADITIONAL)
ATTN: SABINE SCHROEDEL PHONE NO : 499 131 848285 HENKESTRASSE 127 SE DECISION MADE: 14-NOV-08 ERLANGEN, GERMANY 91052 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SYNGO MR B17 SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K082427(TRADITIONAL)
ATTN: ELIZABETH LAZARO PHONE NO : 610-448-3393 51 VALLEY STREAM PKWY. SE DECISION MADE: 07-NOV-08 MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYMBIA, VERSION 4.0 SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K082506(TRADITIONAL)
ATTN: GUNHILD PAULSEN PHONE NO : 847-304-7516 2501 NORTH BARRINGTON RD. SE DECISION MADE: 21-NOV-08 HOFFMAN ESTATES, IL 60192 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K082142(TRADITIONAL)
ATTN: SHELLY PEARCE PHONE NO : 650-694-5988 1230 SHOREBIRD WAY SE DECISION MADE: 13-NOV-08 MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIMPACT ENDOSSEOUS DENTAL IMPLANT SYSTEM SIMPACT LLC 510(k) NO: K083141(SPECIAL)
ATTN: MARK SCHENK PHONE NO : 973-588-8932 300 INTERPACE PARKWAY SE DECISION MADE: 07-NOV-08 SUITE 410 510(k) SUMMARY AVAILABLE FROM FDA PARSIPPANY, NJ 07054 DEVICE: OSTEORAPTOR SUTURE ANCHOR SMITH & NEPHEW INC., ENDOSCOPY DIV510(k) NO: K082215(TRADITIONAL)
ATTN: JULIE ACKER PHONE NO : 508-261-3618 150 MINUTEMAN RD. SE DECISION MADE: 03-NOV-08 ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RENASYS-F NEGATIVE PRESSURE WOUND THERAPY FOAM DRESSING KITS SMITH & NEPHEW, INC 510(k) NO: K082211(TRADITIONAL)
ATTN: LAURA KREJCI PHONE NO : 727-329-7702 970 LAKE CARILLON DRIVE, SE DECISION MADE: 14-NOV-08 SUITE 110 510(k) SUMMARY AVAILABLE FROM FDA ST. PETERSBURG, FL 33716 DEVICE: SMITH & NEPHEW, INC. PATIENT MATCHED TECHNOLOGY SMITH & NEPHEW, INC. 510(k) NO: K082358(TRADITIONAL)
ATTN: MEGAN BEVILL PHONE NO : 901-399-5340 1450 BROOKS RD. SE DECISION MADE: 25-NOV-08 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODEL ESSENTIAL CONE SOADCO, S.L. 510(k) NO: K082200(TRADITIONAL)
ATTN: MARIA MITJANETA PHONE NO : 376 800 590 AV FITER I ROSSELL SE DECISION MADE: 25-NOV-08 4 BIS LOCAL 2 510(k) SUMMARY AVAILABLE FROM FDA ESCALDES-ENGORDANY, ANDORRA AD-700 DEVICE: MODIFICATION TO 4CIS VANE SPINE SYSTEM SOLCO BIOMEDICAL CO., LTD. 510(k) NO: K081145(SPECIAL)
ATTN: SAEYOUNG AHN PHONE NO : 240-499-4290 155 GIBBS ST., SUITE 512 SE DECISION MADE: 05-NOV-08 ROCKVILLE, MD 20850 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SH14 HEMOCONCENTRATOR SORIN GROUP ITALIA S.R.L. 510(k) NO: K081313(ABBREVIATED)
ATTN: BARRY SALL PHONE NO : 781-434-4742 200 WEST STREET SE DECISION MADE: 19-NOV-08 WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPECTRA-GLASS LOR (LOSS OF RESISTANCE SYRINGE, 5CC METAL L/S OR SPECTRA MEDICAL DEVICES, INC. 510(k) NO: K082674(TRADITIONAL)
ATTN: SCOTT HENDERSON PHONE NO : 757-220-8917 260-F&H FORDHAM RD SE DECISION MADE: 28-NOV-08 WILMINGTON, MA 01887 510(k) STATEMENT DEVICE: BODY CONTROL SYSTEM FAMILY, BODY CONTROL DUO AND CT5 SPORT-ELEC S.A. 510(k) NO: K081026(TRADITIONAL)
ATTN: SHARON SCANNELL PHONE NO : 757-224-0177 144 RESEARCH DRIVE SE DECISION MADE: 05-NOV-08 HAMPTON, VA 23666 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SRI PLR GOWN SRI/SURGICAL EXPRESS 510(k) NO: K080707(ABBREVIATED)
ATTN: JEFFREY O STULL PHONE NO : 512-288-8272 P.O. BOX 92493 SE DECISION MADE: 13-NOV-08 AUSTIN, TX 78709 510(k) STATEMENT DEVICE: SRI LP DRAPE SRI/SURGICAL EXPRESS 510(k) NO: K080796(ABBREVIATED)
ATTN: JEFFREY O STULL PHONE NO : 512-288-8272 P.O. BOX 92493 SE DECISION MADE: 17-NOV-08 AUSTIN, TX 78709 510(k) STATEMENT DEVICE: SRI LP GOWN SRI/SURGICAL EXPRESS, INC. 510(k) NO: K080723(ABBREVIATED)
ATTN: JEFFERY O STULL PHONE NO : 512-288-8272 P.O. BOX 92493 SE DECISION MADE: 13-NOV-08 AUSTIN, TX 78709 510(k) STATEMENT DEVICE: AGILIS NXT STEERABLE INTRODUCER ST. JUDE MEDICAL 510(k) NO: K083083(TRADITIONAL)
ATTN: LAURA MOEN-FTACEK PHONE NO : 952-933-4700 14901 DEVEAU PL. SE DECISION MADE: 06-NOV-08 MINNETONKA, MN 55345-2126 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: STANDARD IMAGING IMSURE BRACHY QA SOFTWARE, MODEL 91331 STANDARD IMAGING, INC. 510(k) NO: K082773(TRADITIONAL)
ATTN: RAYMOND RIDDLE PHONE NO : 608-831-0025 3120 DEMING WAY SE DECISION MADE: 19-NOV-08 MIDDLETON, WI 53562-1461 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STOMA BONE BLOCK SCREW STORZ AM MARK GMBH 510(k) NO: K080430(TRADITIONAL)
ATTN: FRANZ MENEAN PHONE NO : 497 463 995411 EMMINGER STR. 39 SE DECISION MADE: 21-NOV-08 EMMINGEN-LIPTINGEN, GERMANY 78576 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CUFFALERT SUNMED 510(k) NO: K081805(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239-498-2155 24301 WOODSAGE DR. SE DECISION MADE: 14-NOV-08 BONITA SPRINGS, FL 34134-2958 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERITAS COLLAGEN MATRIX (DRY) SYNOVIS SURGICAL INNOVATIONS 510(k) NO: K083039(TRADITIONAL)
ATTN: JODI JORGENSON PHONE NO : 651-796-7300 2575 UNIVERSITY AVE. WEST SE DECISION MADE: 26-NOV-08 ST. PAUL, MN 55114-1024 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHEMED DEVICE SYNTHEMED, INC. 510(k) NO: K082276(TRADITIONAL)
ATTN: ELI PINES PHONE NO : 732-404-1117 200 MIDDLESEX ESSEX TPK. SE DECISION MADE: 18-NOV-08 SUITE 210 510(k) SUMMARY AVAILABLE FROM FDA ISELIN, NJ 08830 DEVICE: SYNTHES (USA) 3.5MM LCP HOOK PLATE SYNTHES (USA) 510(k) NO: K082072(TRADITIONAL)
ATTN: KARL J NITTINGER PHONE NO : 610-719-6941 1301 GOSHEN PKWY. SE DECISION MADE: 07-NOV-08 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM SYNTHES (USA) 510(k) NO: K082335(TRADITIONAL)
ATTN: AMNON TALMOR PHONE NO : 610-719-6604 1301 GOSHEN PKWY. SE DECISION MADE: 10-NOV-08 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES (USA) 3.5MM LCP POSTEROMEDIAL PROXIMAL TIBIA PLATES SYNTHES (USA) 510(k) NO: K082624(TRADITIONAL)
ATTN: KARL J NITTINGER PHONE NO : 610-719-6941 1301 GOSHEN PKWY. SE DECISION MADE: 10-NOV-08 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONAL SYNTHES (USA) 510(k) NO: K082650(TRADITIONAL)
ATTN: JILL R SHERMAN PHONE NO : 610-719-6538 1301 GOSHEN PKWY SE DECISION MADE: 18-NOV-08 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES (USA) 3.5 AND 4.5 MM LOCKING COMPRESSION PLATE SYSTEM WI SYNTHES (USA) 510(k) NO: K082807(TRADITIONAL)
ATTN: JILL R SHERMAN PHONE NO : 610-719-6538 1301 GOSHEN PKWY. SE DECISION MADE: 24-NOV-08 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: USS ILIOSACRAL, USS POLYAXIAL SYNTHES SPINE 510(k) NO: K082572(TRADITIONAL)
ATTN: JASON LIPMAN PHONE NO : 610-719-5629 1302 WRIGHTS LANE EAST SE DECISION MADE: 24-NOV-08 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NITI-S BILIARY STENT TAEWOONG MEDICAL CO., LTD 510(k) NO: K073667(ABBREVIATED)
ATTN: CATHRYN N CAMBRIA PHONE NO : 770-396-5909 5536 TROWBRIDGE DRIVE SE DECISION MADE: 19-NOV-08 DUNWOODY, GA 30338 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLUE MEDICAL AND CLUE MEDICAL BASIC TELOVITAL GMBH TELEMEDIZIN 510(k) NO: K082013(TRADITIONAL)
ATTN: CALLEY HERZOG PHONE NO : 703-562-9800 901 KING ST., SUITE 200 SE DECISION MADE: 10-NOV-08 ALEXANDRIA, VA 22314 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TENACORE OXYGEN BLENDER, MODEL TB-2000 TENACORE HOLDINGS, INC. 510(k) NO: K081335(TRADITIONAL)
ATTN: BRAND CASO PHONE NO : 714-444-4643 647 EAST YOUNG ST. SE DECISION MADE: 14-NOV-08 SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NON-CONTACT TONOMETER, MODEL FT-1000 TOMEY CORPORATION 510(k) NO: K073087(TRADITIONAL)
ATTN: KOJI KUBO PHONE NO : 814 254 81253 2-17-6 AKENBONO-CHO SE DECISION MADE: 18-NOV-08 TACHIKAWA-SHI 510(k) SUMMARY AVAILABLE FROM FDA TOKYO, JAPAN 190-0012 DEVICE: TOP NEUROPOLE NEEDLE, MODEL SH, BL, SC, TC TOP CORP. 510(k) NO: K080771(TRADITIONAL)
ATTN: CATHRYN N CAMBRIA PHONE NO : 770-396-5909 5536 TROWBRIDGE DR SE DECISION MADE: 10-NOV-08 DUNWOODY, GA 30338 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OMNI-DL SYSTEM TRANSVIVO INC. 510(k) NO: K080650(TRADITIONAL)
ATTN: J. MICHAEL DELMAGE PHONE NO : 510-223-1054 3067 RESEARCH DRIVE SE DECISION MADE: 26-NOV-08 RICHMOND, CA 94806 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BENACEL, MODELS C-001, C-002 AND C-005 UNICARE BIOMEDICAL, INC. 510(k) NO: K080532(TRADITIONAL)
ATTN: STAN YANG PHONE NO : 949-643-6707 22971-B TRITON WAY SE DECISION MADE: 12-NOV-08 LAGUNA HILLS, CA 92653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTIMUS 0.035" PTA BALLOON DILATATION CATHETER USCI IRELAND 510(k) NO: K082646(SPECIAL)
ATTN: MAUREEN O'CONNELL PHONE NO : 978-207-1245 5 TIMBER LANE SE DECISION MADE: 03-NOV-08 NORTH READING, MA 01864 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: D-STAT DRY WRAP HEMOSTATIC BANDAGE, MODEL: 3015 VASCULAR SOLUTIONS, INC. 510(k) NO: K083190(SPECIAL)
ATTN: LISA GALLATIN PHONE NO : 763-656-4300 6464 SYCAMORE COURT SE DECISION MADE: 12-NOV-08 MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENTERAL PUMP SET, MODEL 20-1010 VIASYS MEDSYSTEMS 510(k) NO: K081725(TRADITIONAL)
ATTN: STEPHANIE WASIELEWSKI PHONE NO : 847-403-3484 100 CHADDICK DR. SE DECISION MADE: 07-NOV-08 WHEELING, IL 60090 510(k) STATEMENT DEVICE: VIDA PULMONARY WORKSTATION 2 (PW2) VIDA DIAGNOSTICS, INC. 510(k) NO: K083227(TRADITIONAL)
ATTN: JACK SLOVICK PHONE NO : 763-639-0238 100 OAKDALE CAMPUS; SUITE 225 SE DECISION MADE: 18-NOV-08 TIC 510(k) SUMMARY AVAILABLE FROM FDA IOWA CITY, IA 52242 THIRD PARTY REVIEW DEVICE: VERTEBRAL ACCESS SYSTEM BY VIDACARE VIDACARE CORPORATION 510(k) NO: K081713(TRADITIONAL)
ATTN: GRACE HOLLAND PHONE NO : 949-262-0411 3722 AVE. SAUSALITO SE DECISION MADE: 21-NOV-08 IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RAPIDVIT AND RAPIDWARM CLEAVE VITROLIFE SWEDEN AB 510(k) NO: K080446(TRADITIONAL)
ATTN: KJELL KJORK PHONE NO : 46 31 7218077 FAKTORVAGEN 13 SE DECISION MADE: 26-NOV-08 KUNGSBACKA, SWEDEN SE-434 37 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIZTEK DR, MODELS: DR1000, DR3000, DR4000 VIZTEK, INC. 510(k) NO: K082604(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854 PO BOX 7007 SE DECISION MADE: 21-NOV-08 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FUTURABOND M/FUTURABOND M SINGLE DOSE VOCO GMBH 510(k) NO: K082753(TRADITIONAL)
ATTN: MANFRED THOMAS PLAUMANN PHONE NO : 49 472 1719200 ANTON-FLETTNER-STRASSE 1-3 SE DECISION MADE: 24-NOV-08 CUXHAVEN, GERMANY D-27472 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERICORE IMPLANT ABUTMENTS WHIP-MIX CORP. 510(k) NO: K082299(TRADITIONAL)
ATTN: DAVID J STEINBOCK PHONE NO : 502-364-1451 361 FARMINGTON AVE. SE DECISION MADE: 20-NOV-08 LOUISVILLE, KY 40217 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DARCO SMALL SCREW WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K082320(TRADITIONAL)
ATTN: SARAH HOLTGREWE PHONE NO : 901-867-4476 5677 AIRLINE RD. SE DECISION MADE: 05-NOV-08 ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WU'S 4-WHEELED NEO SCOOTER, WT-M3A WU'S TECH CO., LTD. 510(k) NO: K082963(TRADITIONAL)
ATTN: JEN KEN-MIN PHONE NO : 886 352 08829 NO. 58, FU-CHIUN ST. SE DECISION MADE: 24-NOV-08 NSIN-CHU CITY, CHINA (TAIWAN) 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM: DISTAL HUMERAL AND PR ZIMMER, INC. 510(k) NO: K082078(TRADITIONAL)
ATTN: ANTHONY FRANCALANCIA PHONE NO : 574-372-4570 P.O. BOX 708 SE DECISION MADE: 03-NOV-08 WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 212 TOTAL WITH SUMMARIES 192 TOTAL WITH STATEMENTS 20
Updated December 5, 2008
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