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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