SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE) 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD 01-SEP-2008 THROUGH 30-SEP-2008 DEVICE: ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL C ABBOT LABORATORIES 510(k) NO: K081231(TRADITIONAL)
ATTN: CAROL JOCHUM PHONE NO : 847-937-2119 100 ABBOTT PARK RD. SE DECISION MADE: 26-SEP-08 DEPT. 049D BLDG. AP 6C-2 510(k) SUMMARY AVAILABLE FROM FDA ABBOTT PARK, IL 60064-6092 DEVICE: PRECISION XCEED PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM ABBOTT DIABETES CARE INC. 510(k) NO: K080960(TRADITIONAL)
ATTN: TAMMY WHARTON PHONE NO : 510-749-5273 1360 SOUTH LOOP RD. SE DECISION MADE: 05-SEP-08 ALAMEDA, CA 94502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATO ABBOTT LABORATORIES 510(k) NO: K080696(TRADITIONAL)
ATTN: CAROL JOCHUM PHONE NO : 847-937-2119 100 ABBOTT PARK RD. SE DECISION MADE: 11-SEP-08 ABBOTT PARK, IL 60064 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM ABBOTT VASCULAR-VASCULAR SOLUTIONS510(k) NO: K081523(TRADITIONAL)
ATTN: DANIELLE TAYLOR PHONE NO : 408-845-0883 3200 LAKESIDE DR. SE DECISION MADE: 11-SEP-08 SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TYMPANOSTOMY TUBE ACCLARENT, INC. 510(k) NO: K082188(TRADITIONAL)
ATTN: KERI YEN PHONE NO : 650-687-5874 1525-B O'BRIEN DR. SE DECISION MADE: 19-SEP-08 MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACRYDERM ABSORBENT OXYGEN DRESSING ACRYMED, INC. 510(k) NO: K082459(TRADITIONAL)
ATTN: BRUCE GIBBINS PHONE NO : 503-624-9830 9560 SW NIMBUS AVE SE DECISION MADE: 19-SEP-08 BEAVERTON, OR 97008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RE-ZORB PLATING SYSTEM ACUTE INNOVATIONS LLC 510(k) NO: K081588(TRADITIONAL)
ATTN: ALYSSA THOMAS PHONE NO : 503-207-1294 21421 NW JACOBSON RD. SE DECISION MADE: 03-SEP-08 SUITE 700 510(k) SUMMARY AVAILABLE FROM FDA HILLSBORO, OR 97124 DEVICE: NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING, SILVERCEL NON-ADHE ADVANCED MEDICAL SOLUTIONS LIMITED510(k) NO: K081363(TRADITIONAL)
ATTN: CLAIRE RYAN PHONE NO : 440 160 6863500 ROAD THREE SE DECISION MADE: 24-SEP-08 WINSFORD INDUSTRIAL ESTATE 510(k) SUMMARY AVAILABLE FROM FDA WINSFORD CHESHIRE, UNITED KINGDOM CW7 3PD DEVICE: YEAST TRAFFIC LIGHT PNA FISH ADVANDX, INC. 510(k) NO: K080719(TRADITIONAL)
ATTN: HENRIK STENDER PHONE NO : 781-376-0009 10A ROESSLER ROAD SE DECISION MADE: 12-SEP-08 WOBURN, MA 01801 510(k) STATEMENT DEVICE: AESCULAP IMPLANT SYSTEMS HIGH TIBIAL OSTEOTOMY PLATING SYSTEM AESCULAP IMPLANT SYSTEMS, INC. 510(k) NO: K080992(TRADITIONAL)
ATTN: LISA BOYLE PHONE NO : 610-797-9300 3773 CORPORATE PKWY. SE DECISION MADE: 04-SEP-08 CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNIVATION UNICONDYLAR KNEE SYSTEM AESCULAP IMPLANT SYSTEMS, INC. 510(k) NO: K081293(TRADITIONAL)
ATTN: LISA M BOYLE PHONE NO : 610-984-9291 3773 CORPORATE PKWY. SE DECISION MADE: 22-SEP-08 CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD AESCULAP IMPLANT SYSTEMS, INC. 510(k) NO: K082146(SPECIAL)
ATTN: KATHY A RACOSKY PHONE NO : 610-984-9291 3773 CORPORATE PWKY. SE DECISION MADE: 09-SEP-08 CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: S40 CREATINE KINASE (CK) ALFA WASSERMANN DIAGNOSTIC TECHNOL510(k) NO: K082226(TRADITIONAL)
ATTN: DENNIS TASCHEK PHONE NO : 973-852-0177 4 HENDERSON DRIVE SE DECISION MADE: 18-SEP-08 WEST CALDWELL, NJ 07006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOVEL CERVICAL SPINAL SPACER SYSTEM ALPHATEC SPINE, INC. 510(k) NO: K081730(TRADITIONAL)
ATTN: MARY SCANNERS PHONE NO : 760-494-6771 2051 PALOMAR AIRPORT ROAD SE DECISION MADE: 19-SEP-08 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA CARLSBAD, CA 92011 DEVICE: SEEPLATE CERVICAL PLATE SYSTEM AMEDICA CORP. 510(k) NO: K082037(SPECIAL)
ATTN: ADAM HERDER PHONE NO : 202-552-5819 1331 H ST. NW, 12TH FLOOR SE DECISION MADE: 26-SEP-08 WASHINGTON, DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPARC SYSTEM / MONARC, MONARC C, MONARC + SYSTEMS AMERICAN MEDICAL SYSTEMS, INC. 510(k) NO: K081613(TRADITIONAL)
ATTN: SARAH PETERSON PHONE NO : 952-930-6431 10700 BREN RD., WEST SE DECISION MADE: 17-SEP-08 MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VISUAL PHACOEMULSIFICATION SYSTEM, MODEL 551 AMERICAN OPTISURGICAL, INC. 510(k) NO: K080803(TRADITIONAL)
ATTN: DAVID SALZBERG PHONE NO : 949-580-1266 25501 ARCTIC OCEAN SE DECISION MADE: 22-SEP-08 LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMICAS PACS, VERSION 6.0 AMICAS, INC. 510(k) NO: K082144(TRADITIONAL)
ATTN: PATRICE JC NEDELEC PHONE NO : 617-779-7858 20 GUEST ST. SE DECISION MADE: 05-SEP-08 BOSTON, MA 02135 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMARTPORT CT VORTEX; LP TITANIUM, SINGLE PLASTIC, SINGLE TITANIU ANGIODYNAMICS, INC. 510(k) NO: K081472(TRADITIONAL)
ATTN: BRIAN KUNST PHONE NO : 518-798-1215 603 QUEENSBURY AVE. SE DECISION MADE: 23-SEP-08 QUEENSBURY, NY 12804 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACTIFUSE FLOW BONE GRAFT SUBSTITUTE APATECH LTD. 510(k) NO: K082073(TRADITIONAL)
ATTN: CANDACE F CEDERMAN PHONE NO : 503-722-7494 15058 ARMEL DRIVE SE DECISION MADE: 11-SEP-08 OREGON CITY, OR 97045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APPLIED BIOSYSTEMS 7500 FAST DX APPLIED BIOSYSTEMS INC 510(k) NO: K082562(TRADITIONAL)
ATTN: JOHN D'ANGELO PHONE NO : 650-554-2005 850 LINCOLN CENTER DRIVE SE DECISION MADE: 30-SEP-08 FOSTER CITY, CA 94404-1128 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARDS DENTAL IMPLANTS ARDS, LTD 510(k) NO: K071803(TRADITIONAL)
ATTN: GEORGE J HATTUB PHONE NO : 508-479-6116 291 HILLSIDE AVENUE SE DECISION MADE: 05-SEP-08 SOMERSET, MA 02726 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SILVERMED ANTIMICROBIAL SILVER HYDROGEL ARGENTIS BIOMEDICAL INCORPORATED 510(k) NO: K073019(TRADITIONAL)
ATTN: TONI MILLER PHONE NO : 201-615-1212 26 CHESTNUT RIDGE ROAD #12 SE DECISION MADE: 16-SEP-08 MONTVALE, NJ 07645 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAVE RESUSCITATOR ARTIVENT CORPORATION 510(k) NO: K073410(TRADITIONAL)
ATTN: GRACE HOLLAND PHONE NO : 949-262-0411 3722 AVE. SAUSALITO SE DECISION MADE: 12-SEP-08 IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED ELECTROPHYSIOLOGY CATHETERS ASCENT HEALTHCARE SOLUTIONS 510(k) NO: K082023(TRADITIONAL)
ATTN: AMANDA BABCOCK PHONE NO : 480-763-5376 10232 SOUTH 51ST ST. SE DECISION MADE: 16-SEP-08 PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSSEOSPEED TM PROFILE SYSTEM ASTRA TECH AB 510(k) NO: K080156(TRADITIONAL)
ATTN: LINDA K SCHULZ PHONE NO : 858-792-1235 11234 EL CAMINO REAL, SE DECISION MADE: 17-SEP-08 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92130 DEVICE: MODIFICATION TO AURORA MRI SYSTEM AURORA IMAGING TECHNOLOGY, INC. 510(k) NO: K073425(TRADITIONAL)
ATTN: MICHAEL A DOUGLAS PHONE NO : 978-975-7530 39 HIGH ST. SE DECISION MADE: 16-SEP-08 NORTH ANDOVER, MA 01845 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25 BAXANO, INC. 510(k) NO: K081742(TRADITIONAL)
ATTN: TRENA DEPEL PHONE NO : 650-937-1400 2660 MARINE WAY, SUITE B SE DECISION MADE: 17-SEP-08 MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HANDHELD ECG MONITOR, MODEL MD100 BEIJING CHOICE ELECTRONIC TECHNOLO510(k) NO: K080933(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 86 21 64264467 SUITE 8D ZHONGXIN ZHONGSHAN SE DECISION MADE: 26-SEP-08 MANSION, NO. 19, LANE 999 510(k) SUMMARY AVAILABLE FROM FDA SHANGHAI, CHINA 20020 DEVICE: EYEFEEL OPHTHALMIC WARMER BIO-LIPID, INC. 510(k) NO: K082087(TRADITIONAL)
ATTN: PAMELA FURMAN PHONE NO : 202-661-7888 1700 PENNSYLVANIA AVE., NW SE DECISION MADE: 11-SEP-08 WASHINGTON, DC 20006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIO-MED SOFT INSULIN SYRINGE: MODELS 1CC, 0.5CC, 0.3CC BIO-MED U.S.A., INC. 510(k) NO: K081547(TRADITIONAL)
ATTN: YOUNG CHI PHONE NO : 973-278-5222 111 ELLISON ST. SE DECISION MADE: 08-SEP-08 PATERSON, NJ 07505 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LYPHOCHEK TUMOR MARKET PLUS CONTROL LEVEL 1, 2 AND 3 AND MINIPAK BIO-RAD LABORATORIES 510(k) NO: K082036(TRADITIONAL)
ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285 9500 JERONIMO RD. SE DECISION MADE: 08-SEP-08 IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FORTOSS VITAL BIOCOMPOSITES LTD. 510(k) NO: K082383(SPECIAL)
ATTN: MARIE WHALLEY PHONE NO : 441 782 338580 KEELE SCIENCE PARK SE DECISION MADE: 05-SEP-08 KEELE, STAFFORDSHIRE, UNITED KINGD510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROL BIOKIT S.A. 510(k) NO: K082141(ABBREVIATED)
ATTN: JOAN GUIXER PHONE NO : 349 386 09000 CAN MALE S/N SE DECISION MADE: 03-SEP-08 LLICA D'AMUNT 510(k) SUMMARY AVAILABLE FROM FDA BARCELONA, SPAIN 08186 DEVICE: VIDAS AFP ASSAY BIOMERIEUX, INC. 510(k) NO: K080017(TRADITIONAL)
ATTN: NIKITA S MAPP PHONE NO : 314-731-7474 595 ANGLUM RD. SE DECISION MADE: 26-SEP-08 HAZELWOOD, MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM110 BIONIME CORPORATION 510(k) NO: K081450(SPECIAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 949-429-5825 55 NORTHERN BLVD. SUITE 200 SE DECISION MADE: 11-SEP-08 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM100 BIONIME CORPORATION 510(k) NO: K081451(SPECIAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 949-429-5825 55 NORTHERN BLVD. SUITE 200 SE DECISION MADE: 18-SEP-08 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLUCOSE METER-CHECK CONTROL SOLUTION FOR BAYER ASCENSIA BLOOD GL BIONOSTICS, INC. 510(k) NO: K082395(TRADITIONAL)
ATTN: KATHLEEN STORRO PHONE NO : 978-772-7070 7 JACKSON RD. SE DECISION MADE: 18-SEP-08 DEVENS, MA 01434 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VISUALASE THERMAL THERAPY SYSTEM BIOTEX, INC. 510(k) NO: K081656(TRADITIONAL)
ATTN: ROGER MCNICHOLS PHONE NO : 713-741-0111 8058 EL RIO ST. SE DECISION MADE: 10-SEP-08 HOUSTON, TX 77054-4185 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGVIEW INTEGRATED VISUALIZATION SYSTEM BIOVISION TECHNOLOGIES, LLC 510(k) NO: K082293(TRADITIONAL) ATTN: PHONE NO : 221 CORPORATE CIRCLE SE DECISION MADE: 09-SEP-08 SUITE H 510(k) SUMMARY AVAILABLE FROM FDA GOLDEN, CO 80401 THIRD PARTY REVIEW DEVICE: BISCEM TRANSLUCENT, MODEL D-45011; BISCEM OPAQUE, MODEL D-45012 BISCO, INC. 510(k) NO: K082449(SPECIAL)
ATTN: MICHELLE SCHILTZ-TAING PHONE NO : 847-534-6000 1100 WEST IRVING PARK RD. SE DECISION MADE: 25-SEP-08 SCHAUMBURG, IL 60193 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLACKSTONE PEDICLE SCREW SYSTEM BLACKSTONE MEDICAL, INC. 510(k) NO: K081684(TRADITIONAL)
ATTN: WHITNEY G TORNING PHONE NO : 973-406-2838 1211 HAMBURG TURNPIKE SE DECISION MADE: 15-SEP-08 SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA WAYNE, NJ 07470 DEVICE: BLACKSTONE PILLAR XL PEEK SPACERS BLACKSTONE MEDICAL, INC. 510(k) NO: K082235(SPECIAL)
ATTN: WHITNEY G TORNING PHONE NO : 973-406-2838 1211 HAMBURG TURNPIKE SE DECISION MADE: 04-SEP-08 SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA WAYNE, NJ 07470 DEVICE: POLYFLEX STENT SYSTEM WITH DELIVERY SYSTEM, MODEL M00514270, M00 BOSTON SCIENTIFIC CORPORATION 510(k) NO: K080332(TRADITIONAL)
ATTN: ASHLEY PYLE PHONE NO : 508-683-4359 100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 05-SEP-08 MARLBOROUGH, MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BRAINLAB KNEE ESSENTIAL, BRAINLAB KNEE UNLIMITED CI KNEE, CI KNE BRAINLAB AG 510(k) NO: K073615(TRADITIONAL)
ATTN: PER PERSSON PHONE NO : 498 999 15680 KAPELLENSTRASSE 12 SE DECISION MADE: 05-SEP-08 FELDKIRCHEN, GERMANY 85622 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3M UNITEK LAVA CHAIRSIDE ORAL SCANNER BRONTES TECHNOLOGIES 510(k) NO: K081961(TRADITIONAL)
ATTN: JOHN GREENBAUM PHONE NO : 954-680-2548 20310 SW 48TH ST. SE DECISION MADE: 05-SEP-08 SOUTHWEST RANCHES, FL 33332 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROTHERMX-100 MICROWAVE ABLATION SYSTEM AND ACCESSORIES BSD MEDICAL SYSTEMS CORP. 510(k) NO: K081042(TRADITIONAL)
ATTN: PHIL TRIOLO PHONE NO : 801-699-9846 148 S. 1200 E. SE DECISION MADE: 03-SEP-08 SALT LAKE CITY, UT 84102-1643 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENTRIO HERNIA PATCH C.R. BARD, INC. 510(k) NO: K081777(TRADITIONAL)
ATTN: STEPHANIE BAKER PHONE NO : 401-825-8588 100 CROSSINGS BLVD. SE DECISION MADE: 29-SEP-08 WARWICK, RI 02886 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVAULTA SUPPORT SYSTEM C.R. BARD, INC. 510(k) NO: K082571(SPECIAL)
ATTN: JOHN C KNORPP PHONE NO : 678-342-4920 13183 HARLAND DRIVE SE DECISION MADE: 30-SEP-08 COVINGTON, GA 30014-6421 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TANDEMHEART TRANSSEPTAL CANNULA- EF 72 CARDIAC ASSIST, INC. 510(k) NO: K082425(SPECIAL)
ATTN: ROBERT BOLLINGER PHONE NO : 412-963-7770 240 ALPHA DR. SE DECISION MADE: 18-SEP-08 PITTSBURGH, PA 15238 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM CARDICA, INC. 510(k) NO: K081225(TRADITIONAL)
ATTN: ISKRA MRAKOVIC PHONE NO : 650-331-7153 900 SAGINAW DR. SE DECISION MADE: 05-SEP-08 REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE MODEL HBPK-A CARDICARE COMPANY, LTD. 510(k) NO: K082542(TRADITIONAL) ATTN: PHONE NO : 9 YAN AN ROAD, WU SHAN PLAZA SE DECISION MADE: 17-SEP-08 TOWN, UNIT 7003 510(k) SUMMARY AVAILABLE FROM FDA HANGZHOU, ZHEJIANG, CHINA 310002 THIRD PARTY REVIEW DEVICE: CDC HUMAN INFLUENZA VIRUS REAL-TIME RT- PCR DETECTION AND CHARAC CENTERS FOR DISEASE CONTROL AND PR510(k) NO: K080570(TRADITIONAL)
ATTN: STEPHEN LINDSTROM PHONE NO : 404-639-1587 1600 CLIFTON RD.,MS-C12 SE DECISION MADE: 30-SEP-08 ATLANTA, GA 30333 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XPERT MRSA/SA SSTI ASSAY CEPHEID 510(k) NO: K080837(TRADITIONAL)
ATTN: RUSSEL K ENNIS PHONE NO : 408-400-8230 904 CARIBBEAN DRIVE SE DECISION MADE: 24-SEP-08 SUNNYVALE, CA 94089-1189 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XPERT MRSA/SA BLOOD CULTURE ASSAY CEPHEID 510(k) NO: K082140(TRADITIONAL)
ATTN: RUSSEL K ENNS PHONE NO : 408-400-8230 904 CARIBBEAN DRIVE SE DECISION MADE: 29-SEP-08 SUNNYVALE, CA 94089-1189 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AOC-LV CEREMED, INC. 510(k) NO: K082245(TRADITIONAL)
ATTN: TADEUSZ WELLISZ PHONE NO : 310-815-2125 3643 LENAWEE AVE. SE DECISION MADE: 18-SEP-08 LOS ANGELES, CA 90016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTENE CT SOLUBLE BONE HEMOSTASIS IMPLANT MATERIAL, AOC CT, AOC, CEREMED, INC. 510(k) NO: K082491(SPECIAL)
ATTN: TADEUSZ WELLISZ PHONE NO : 310-815-2125 3643 LENAWEE AVE. SE DECISION MADE: 24-SEP-08 LOS ANGELES, CA 90016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CIVASTRING PD-103 CIVATECH ONCOLOGY, INC. 510(k) NO: K082159(TRADITIONAL)
ATTN: LOIS V SMART PHONE NO : 919-563-0869 1317 BUCHANAN DR. SE DECISION MADE: 30-SEP-08 MEBANE, NC 27302 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Z3D CONTRAST ACUITY CLARIO MEDICAL IMAGING, INC. 510(k) NO: K080196(TRADITIONAL)
ATTN: CHRIS WOOD PHONE NO : 206-448-2212 1924 FIRST AVE., SUITE 4W SE DECISION MADE: 05-SEP-08 SEATTLE, WA 98101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIZZYFIX CLEARWATER CLINICAL LIMITED 510(k) NO: K081602(TRADITIONAL)
ATTN: MATTHEW BROMWICH PHONE NO : 513 376 9567 100-111 5TH AVE. SW SE DECISION MADE: 19-SEP-08 SUITE 258 510(k) SUMMARY AVAILABLE FROM FDA CALGARY, ALBERTA, CANADA T2P 3Y6 DEVICE: CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2 CLINIQA CORPORATION 510(k) NO: K082107(TRADITIONAL)
ATTN: CAROL RUGGIERO PHONE NO : 760-744-1900 288 DISTRIBUTION STREET SE DECISION MADE: 17-SEP-08 SAN MARCOS, CA 92078 510(k) STATEMENT DEVICE: CLARO CLRS TECHNOLOGY CORPORATION 510(k) NO: K080638(TRADITIONAL)
ATTN: MAUREEN O'CONNELL PHONE NO : 978-207-1245 5 TIMBER LANE SE DECISION MADE: 17-SEP-08 NORTH READING, MA 01864 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPUMEDICS NEUVO COMPUMEDICS USA, LTD. 510(k) NO: K081151(SPECIAL)
ATTN: DAVID CARDONA PHONE NO : 704-749-3249 6605 WEST WT HARRIS BLVD SE DECISION MADE: 08-SEP-08 SUITE F 510(k) SUMMARY AVAILABLE FROM FDA CHARLOTTE, NC 28269 THIRD PARTY REVIEW DEVICE: BEAMER ARGON PROBE CONMED CORPORATION 510(k) NO: K081644(TRADITIONAL)
ATTN: KAREN PROVENCHER PHONE NO : 978-964-4232 129 CONCORD RD. SE DECISION MADE: 10-SEP-08 BLDG. #3 510(k) SUMMARY AVAILABLE FROM FDA BILLERICA, MA 01821 THIRD PARTY REVIEW DEVICE: CONMED LINVATEC MICROFRACTURE INSTRUMENT STERILIZATION TRAY CONMED LINVATEC 510(k) NO: K080531(TRADITIONAL)
ATTN: JON WARD PHONE NO : 813-645-2855 11311 CONCEPT BOULEVARD SE DECISION MADE: 05-SEP-08 LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERSAPOD (TM) INSTRUMENT TRAYS CONTAINMED, INC. 510(k) NO: K071783(TRADITIONAL)
ATTN: TODD E BETTENHAUSEN PHONE NO : 317-487-8800 1404 MAIN ST SE DECISION MADE: 09-SEP-08 SPEEDWAY, IN 46224 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNISYN IMAGE FUSION, VERSION 1.0 CONVERGENT IMAGING SOLUTIONS 510(k) NO: K081987(TRADITIONAL)
ATTN: MATHEW A THOMAS PHONE NO : 613 239 0421 49 FIRST AVE. SUITE B SE DECISION MADE: 26-SEP-08 OTTAWA, ONTARIO, CANADA K1S 2G1 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INJEKT FILIFORM INJECTION NEEDLE COOK UROLOGICAL, INC. 510(k) NO: K082319(TRADITIONAL)
ATTN: CINDY FOOTE PHONE NO : 812-829-4891 1100 WEST MORGAN ST. SE DECISION MADE: 25-SEP-08 SPENCER, IN 47460 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER INJEC COOK VASCULAR, INC. 510(k) NO: K081425(TRADITIONAL)
ATTN: JIM FERGUSON PHONE NO : 724-845-8621 1186 MONTGOMERY LANE SE DECISION MADE: 30-SEP-08 VANDERGRIFT, PA 15690 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROCLEAR MULTIFOCAL TORIC AND XR AND TORIC XR COOPERVISION, INC. 510(k) NO: K081865(SPECIAL)
ATTN: BONNIE TSYMBAL PHONE NO : 585-264-3210 711 NORTH RD. SE DECISION MADE: 29-SEP-08 SCOTTSVILLE, NY 14546 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRUFILL DCS SYRINGE CORDIS NEUROVASCULAR, INC. 510(k) NO: K082324(SPECIAL) ATTN: AMARILYS MACHADO PHONE NO : 786-313-6493 14201 NW 60TH AVENUE SE DECISION MADE: 12-SEP-08 MIAMI LAKES, FL 33014 510(k) STATEMENT DEVICE: BT3/6, BT12 CORSCIENCE GMBH & CO. KG 510(k) NO: K082077(TRADITIONAL)
ATTN: PATRIK KAREM PHONE NO : 412-372-8571 700-706 SECO RD SE DECISION MADE: 02-SEP-08 MONROEVILLE, PA 15146 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MODIFIED ENDO STICH COVIDIEN LP, FORMERLY REGISTERED A510(k) NO: K082659(SPECIAL)
ATTN: ROBERT ZOTT PHONE NO : 203-492-6013 60 MIDDLETOWN AVENUE SE DECISION MADE: 19-SEP-08 NORTH HAVEN, CT 06473 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEALOS FX INJECTABLE BONE GRAFT REPLACEMENT, MODELS 276175002, 2 DEPUY SPINE, INC. 510(k) NO: K081758(TRADITIONAL)
ATTN: HANDE TUFAN PHONE NO : 508-828-3065 325 PARAMOUNT DR. SE DECISION MADE: 03-SEP-08 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXPEDIUM SPINE SYSTEM DEPUY SPINE, INC. 510(k) NO: K081898(SPECIAL)
ATTN: CHRISTOPHER KLACZYK PHONE NO : 508-828-2852 325 PARAMOUNT DR. SE DECISION MADE: 10-SEP-08 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATIONS TO EXPEDIUM SPINE SYSTEM DEPUY SPINE, INC. 510(k) NO: K082195(SPECIAL)
ATTN: FRANK JURCZAK PHONE NO : 508-828-3288 325 PARAMOUNT DR. SE DECISION MADE: 03-SEP-08 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM DEPUY SPINE, INC. 510(k) NO: K082273(SPECIAL)
ATTN: FRANK JURCZAK PHONE NO : 508-828-3288 325 PARAMOUNT DR. SE DECISION MADE: 10-SEP-08 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PORTABLE X-RAY SYSTEM, MODELS DIOX-602, PROX DIGIMED CORPORATION 510(k) NO: K082167(TRADITIONAL)
ATTN: SHIN KUK YOO PHONE NO : 801-303-7440 215 S. STATE STREET, STE 100B SE DECISION MADE: 26-SEP-08 SALT LAKE CITY, UT 84111 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDIUS-1, -2, -3, AND CARDIUS 1,2,3 XPO SPECT IMAGING SYSTEMS, DIGIRAD CORP. 510(k) NO: K082368(SPECIAL)
ATTN: JOEL TUCKEY PHONE NO : 858-726-1600 13950 STOWE DRIVE SE DECISION MADE: 12-SEP-08 POWAY, CA 92064-8803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGNITY 100 DIGNITY MEDICAL DEVICES, INC 510(k) NO: K082246(TRADITIONAL)
ATTN: CHARMAINE SUTTON PHONE NO : 763-416-4213 16917 73RD PLACE N SE DECISION MADE: 09-SEP-08 MAPLE GROVE, MN 55311 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SELLAS DINONA CO., LTD. 510(k) NO: K080382(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412 13 RED FOX LANE SE DECISION MADE: 24-SEP-08 LITTLETON, CO 80127 510(k) STATEMENT DEVICE: INFILTRATION KIT DMG USA, INC. 510(k) NO: K081493(ABBREVIATED)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552 5 WHITCOMB AVE. SE DECISION MADE: 18-SEP-08 AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS DRAEGER MEDICAL AG & CO. KG 510(k) NO: K081743(TRADITIONAL)
ATTN: KARIN LUEBBERS PHONE NO : 49 451 8825367 53/55 MOISLINGER ALLEE SE DECISION MADE: 22-SEP-08 LUEBECK, GERMANY 23542 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DENJECTOR DXM CO., LTD. 510(k) NO: K081694(TRADITIONAL)
ATTN: MARIA GRIFFIN PHONE NO : 631-421-4587 55 NORTHERN BLVD. SE DECISION MADE: 12-SEP-08 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA GREAT NECK, NY 11021 DEVICE: DYNAREX/TILLOTSON NON-STERILE POWDER FREE BLUE NITRILE PATIENT E DYNAREX CORPORATION 510(k) NO: K081569(ABBREVIATED)
ATTN: VIJAY SACHDEV PHONE NO : 845-365-8200 10 GLENSHAW ST. SE DECISION MADE: 12-SEP-08 ORANGEBURG, NY 10962 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 5MP GRAYSCALE FLAT PANEL DISPLAY, MODEL, 6GF6201-5C$2# (WHERE $ EIZO GMBH 510(k) NO: K081357(TRADITIONAL)
ATTN: JAMES BERGE PHONE NO : 497 215 955227 SIEMENSALLEE 84 SE DECISION MADE: 05-SEP-08 KARLSRUHE, GERMANY 76187 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENCORE SHOULDER REVISION GLENOID ENCORE MEDICAL, L.P. 510(k) NO: K081448(TRADITIONAL)
ATTN: TEFFANY HUTTO PHONE NO : 512-834-6255 9800 METRIC BLVD. SE DECISION MADE: 30-SEP-08 AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PTFE INTERLOCK PEELABLE INTRODUCERS ENPATH MEDICAL, INC. 510(k) NO: K081394(SPECIAL)
ATTN: SHANNON SPRINGER PHONE NO : 763-951-8181 2300 BERKSHIRE LANE NORTH SE DECISION MADE: 15-SEP-08 MINNEAPOLIS, MN 55441 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE ENTELLUS MEDICAL, INC. 510(k) NO: K082569(TRADITIONAL)
ATTN: SEW-WAH TAY PHONE NO : 612-801-6782 18555 37TH AVENUE NORTH SE DECISION MADE: 18-SEP-08 PLYMOUTH, MN 55446 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL # EPS08005 EPS BIO TECHNOLOGY CORP. 510(k) NO: K082121(SPECIAL)
ATTN: Y.C. LEI PHONE NO : 886 357 52522 2 F,NO. 49-2, LANE 2, SEC. 2, SE DECISION MADE: 17-SEP-08 GUANG FU ROAD 510(k) STATEMENT HSINCHU CITY, CHINA (TAIWAN) 30071 DEVICE: MODEL 6150 (MYLAB70) AND MODEL 6100 (MYLAB90) ESAOTE S.P.A. 510(k) NO: K081386(TRADITIONAL)
ATTN: ALLISON SCOTT PHONE NO : 317-569-9500 11460 N. MERIDIAN ST. SE DECISION MADE: 25-SEP-08 SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA CARMEL, IN 46032 THIRD PARTY REVIEW DEVICE: TBD ETHICON MESH ETHICON INC. 510(k) NO: K082216(SPECIAL)
ATTN: BRYAN A LISA PHONE NO : 908-218-3392 ROUTE 22 WEST SE DECISION MADE: 05-SEP-08 PO BOX 151 510(k) SUMMARY AVAILABLE FROM FDA SOMERVILLE, NJ 08876 DEVICE: EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT EVENFLO COMPANY, INC. 510(k) NO: K082307(SPECIAL)
ATTN: AMY NEFF PHONE NO : 937-415-3300 225 BYERS RD. SE DECISION MADE: 11-SEP-08 MIAMISBURG, OH 45342 510(k) STATEMENT DEVICE: SYNTHETIC POWDER FREE (PINK) VINYL PATIENT EXAMINATION GLOVE EVER LIGHT PLASTIC PRODUCTS CO., L510(k) NO: K082029(TRADITIONAL)
ATTN: KATHY LIU PHONE NO : 909-591-7888 3973 SCHAEFER AVE SE DECISION MADE: 26-SEP-08 CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTETRAK 9MM CRUCIATE RETAINING TIBIAL INSERT, SLOPE ++ EXACTECH, INC. 510(k) NO: K082022(SPECIAL)
ATTN: GRAHAM CUTHBERT PHONE NO : 352-377-1140 2320 N.W. 66TH CT. SE DECISION MADE: 02-SEP-08 GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STARLIGHT, MODEL PD9012 F.P. RUBINSTEIN Y CIA S.R.L. 510(k) NO: K073317(TRADITIONAL)
ATTN: HAYDEE N DEMARCO PHONE NO : 543 514 240051 DAVID LUQUE 519 SE DECISION MADE: 03-SEP-08 CORDOBA, CBA, ARGENTINA X5004AKM 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FISHER AND PAYKEL HEALTHCARE ZEST NASAL MASK FISHER & PAYKEL HEALTHCARE, LTD. 510(k) NO: K080209(TRADITIONAL)
ATTN: TINA MASON PHONE NO : 011 649 5740100 P.O. BOX 14-348 SE DECISION MADE: 12-SEP-08 AUCKLAND, NEW ZEALAND 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SLEEPSTYLE 200 AUTO SERIES HC254 FISHER & PAYKEL HEALTHCARE, LTD. 510(k) NO: K081029(TRADITIONAL)
ATTN: JAMES THOMPSON PHONE NO : 649 574 0100 15 MAURICE PAYKEL PLACE SE DECISION MADE: 12-SEP-08 EAST TAMAKI, NEW ZEALAND 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARCHITECT CYCLOSPORINE FUJIREBIO DIAGNOSTICS, INC. 510(k) NO: K080751(TRADITIONAL)
ATTN: STACEY MOLL PHONE NO : 610-240-3843 201 GREAT VALLEY PKWY. SE DECISION MADE: 11-SEP-08 MALVERN, PA 19355-1307 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UF-870 AG DIAGNOSTIC ULTRASOUND SYSTEM FUKUDA DENSHI CO., LTD. 510(k) NO: K081919(SPECIAL)
ATTN: LORAN VAN NOY PHONE NO : 425-881-7737 17725 N.E. 65TH STREET SE DECISION MADE: 09-SEP-08 BLDG C 510(k) SUMMARY AVAILABLE FROM FDA REDMOND, WA 98052-4911 THIRD PARTY REVIEW DEVICE: MODEL FF SONIC US-750 XT DIAGNOSTIC ULTRASOUND SYSTEM 3D IMAGING FUKUDA DENSHI USA, INC. 510(k) NO: K082656(TRADITIONAL)
ATTN: LORAN VAN NOY PHONE NO : 425-881-7737 17725 N.E. 65TH ST., BLDG. C SE DECISION MADE: 30-SEP-08 REDMOND, WA 98052-4911 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: VIVID I AND VIVID Q GE MEDICAL SYSTEMS ISRAEL, ULTRASO510(k) NO: K082374(TRADITIONAL)
ATTN: ISRAEL CITRON PHONE NO : 972 4 8519555 HAETGAR STR. 4 SE DECISION MADE: 02-SEP-08 TIRAT CARMEL, ISRAEL 39120 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: GE LIGHTSPEED RT16 / LIGHTSPEED XTRA V2 CT SYSTEM (AKA GE LIGHTS GE MEDICAL SYSTEMS, INC. 510(k) NO: K082104(TRADITIONAL)
ATTN: STEVEN KACHELMEYER PHONE NO : 262-548-2432 3000 N. GRANDVIEW BLVD. SE DECISION MADE: 02-SEP-08 W-706 510(k) SUMMARY AVAILABLE FROM FDA WAUKESHA, WI 53188 THIRD PARTY REVIEW DEVICE: AW SERVER GE MEDICAL SYSTEMS, LLC 510(k) NO: K081985(TRADITIONAL)
ATTN: STEPHEN SLAVENS PHONE NO : 262-548-4992 3000 N GRANDVIEW BLVD. SE DECISION MADE: 25-SEP-08 W706 510(k) SUMMARY AVAILABLE FROM FDA WAUKESHA, WI 53188 THIRD PARTY REVIEW DEVICE: GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION GENERAL ELECTRIC CO. 510(k) NO: K082317(TRADITIONAL)
ATTN: JAMES P RASKOB PHONE NO : 608-826-7425 726 HEARTLAND TRAIL SE DECISION MADE: 26-SEP-08 MADISON, WI 53717 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCELAWAVE SYSTEM GENESIS BIOSYSTEMS, INC. 510(k) NO: K082484(TRADITIONAL)
ATTN: BRIAN BUSS PHONE NO : 972-315-7888 1500 EAGLE COURT SE DECISION MADE: 12-SEP-08 LEWISVILLE, TX 75057 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: D.A.R.T. PRO KIT (D.A.R.T. PRO HANDLE AND X-TRACTOR TIP) GLOBAL PATHOGEN SOLUTIONS INC. 510(k) NO: K081821(TRADITIONAL)
ATTN: CARSON LINKER PHONE NO : 503-679-7612 9515 N.E. 312TH AVE. SE DECISION MADE: 02-SEP-08 CAMAS, WA 98607 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FINGERTIP PULSE OXIMETER, MODEL M70, AND HANDHELD PULSE OXIMETER GUANGDONG BIOLIGHT MEDITECH CO., L510(k) NO: K081712(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 86 21 64264467 ZHONGSHAN NO. 2 RD., LN 999 SE DECISION MADE: 12-SEP-08 SUITE 8D, NO. 19 510(k) SUMMARY AVAILABLE FROM FDA SHANGHAI, CHINA 200030 DEVICE: MODIFICATION TO HAMILTON-G5 HAMILTON MEDICAL AG 510(k) NO: K081521(TRADITIONAL)
ATTN: JOERG SCHNEIDER PHONE NO : 41 816 606010 VIA CRUSCH 8 SE DECISION MADE: 25-SEP-08 BONADUZ, SWITZERLAND CH-7402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HHC, SCORE, HENRY SCHEIN CANISTER HANDPIECE HANDPIECE HEADQUARTERS INC. - HPR 510(k) NO: K080682(ABBREVIATED)
ATTN: TINA STEFFANIE-OAK PHONE NO : 717-335-7230 2284 N. GLASSELL ST., UNIT A SE DECISION MADE: 11-SEP-08 ORANGE, CA 92865 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HASELMEIER PEN 8 HASELMEIER GMBH 510(k) NO: K082616(SPECIAL)
ATTN: STEPHEN J GOLDNER PHONE NO : 248-855-5595 30833 NORTHWESTERN HIGHWAY SE DECISION MADE: 26-SEP-08 SUITE 121 510(k) SUMMARY AVAILABLE FROM FDA FARMINGTON HILL, MI 48334 DEVICE: ULTRASONIC NEBULIZER SYSTEM, MODEL HL100 HEALTH & LIFE CO., LTD. 510(k) NO: K081738(TRADITIONAL)
ATTN: SAMUEL PIPER PHONE NO : 916-483-3687 PO BOX 993 A807 EL CAMINO SE DECISION MADE: 17-SEP-08 SUIT C CARMICHAEL, CA 95609 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEART SYNC PEDIATRIC, MODEL PED-100 HEART SYNC LLC 510(k) NO: K081442(TRADITIONAL)
ATTN: STEPHEN SHULMAN PHONE NO : 734-663-0132 5643 PLYMOUTH ROAD SE DECISION MADE: 24-SEP-08 ANN ARBOR, MI 48105 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRIME ECG SYSTEM (WITH ENHANCED DIAGNOSTIC ALGORITHM) HEARTSCAPE TECHNOLOGIES LTD 510(k) NO: K082312(TRADITIONAL)
ATTN: PAUL PHILLIPS PHONE NO : 442 891 857500 UNIT 1, 6B BALLOO DRIVE SE DECISION MADE: 12-SEP-08 BANGOR, CO DOWN, UNITED KINGDOM B510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EA STIMULATOR HELIO MEDICAL SUPPLIES, INC. 510(k) NO: K080221(TRADITIONAL)
ATTN: YUKUO HSO PHONE NO : 408-433-3355 606 CHARCOT AVE. SE DECISION MADE: 09-SEP-08 SAN JOSE, CA 95131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-16 HELIX MEDICAL, LLC 510(k) NO: K082206(SPECIAL)
ATTN: CYNTHIA ANDERSON PHONE NO : 805-576-5497 1110 MARK AVE. SE DECISION MADE: 04-SEP-08 CARPINTERIA, CA 93013 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFEBED PATIENT VIGILANCE SYSTEM HOANA MEDICAL, INC. 510(k) NO: K082366(SPECIAL)
ATTN: NANCY GERTLAR PHONE NO : 808-523-1225 828 FORT STREET MALL SE DECISION MADE: 26-SEP-08 SUITE 620 510(k) SUMMARY AVAILABLE FROM FDA HONOLULU, HI 96825 DEVICE: 1.10-YEAR FRACTURE RISK QUESTIONNAIRE OPTION FOR QDR X-RAY BONE HOLOGIC, INC. 510(k) NO: K080711(TRADITIONAL)
ATTN: BRYAN COWELL PHONE NO : 781-761-7085 35 CROSBY DR. SE DECISION MADE: 02-SEP-08 BEDFORD, MA 01730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUANTRA HOLOGIC, INC. 510(k) NO: K082483(TRADITIONAL)
ATTN: CATHERINE A WILLIAMS PHONE NO : 408-745-5128 35 CROSBY DR. SE DECISION MADE: 12-SEP-08 BEDFORD, MA 01730 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA UR HORIBA ABX 510(k) NO: K081276(TRADITIONAL)
ATTN: OLIVIER DUCAMP PHONE NO : 33 467 147392 PARC EUROMEDECINE SE DECISION MADE: 12-SEP-08 RUE DU CADUCEE, BP 7290 510(k) SUMMARY AVAILABLE FROM FDA MONTPELLIER, FRANCE 34184 DEVICE: EFFECTIVE (TM) CAP HOSPIRA, INC. 510(k) NO: K080579(TRADITIONAL)
ATTN: REBECCA ANDERSEN PHONE NO : 224-212-5270 275 NORTH FIELD DR. SE DECISION MADE: 11-SEP-08 LAKE FOREST, IL 60045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PACSMATE MMD-3213M MONITOR IEI TECHNOLOGY CORP. 510(k) NO: K082496(TRADITIONAL)
ATTN: SHALLY CHEN PHONE NO : 886 226 902098 NO. 29 JHONG-SING ROAD SE DECISION MADE: 09-SEP-08 SI-JHIH CITY 510(k) SUMMARY AVAILABLE FROM FDA TAIPEI COUNTRY, CHINA (TAIWAN) 221THIRD PARTY REVIEW DEVICE: MDI MII ONE-PIECE IMPLANT, 2.9MM IMTEC CORP. 510(k) NO: K081653(TRADITIONAL) ATTN: GLENN GEE PHONE NO : 580-223-4456 2401 NORTH COMMERCE SE DECISION MADE: 19-SEP-08 ARDMORE, OK 73401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COLLIEVA INNOCOLL PHARMACEUTICALS 510(k) NO: K081782(TRADITIONAL)
ATTN: AARON WYSE PHONE NO : 353 090 6486834 DUBLIN ROAD SE DECISION MADE: 30-SEP-08 ATHLONE, CO. WESTMEATH, IRELAND 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUDICOR, HEMO AMBULATORY MONITOR INOVISE MEDICAL, INC. 510(k) NO: K073545(TRADITIONAL)
ATTN: KENDRA RATHKEY PHONE NO : 503-431-3849 10565 SW NIMBUS AVE. SE DECISION MADE: 09-SEP-08 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA PORTLAND, OR 97223 DEVICE: AUDICOR SENSOR, MODELS: 2.0, 3.0 INOVISE MEDICAL, INC. 510(k) NO: K080602(TRADITIONAL)
ATTN: KENDRA RATHKEY PHONE NO : 503-431-3849 10565 SW NIMBUS AVE. SE DECISION MADE: 25-SEP-08 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA PORTLAND, OR 97223 DEVICE: SNAPSHOT INSTRUMENTARIUM DENTAL, PALODEX GR510(k) NO: K081925(TRADITIONAL)
ATTN: JOUNI ONNELA PHONE NO : 358 457 8822204 NAHKELANTIE 160 SE DECISION MADE: 02-SEP-08 TUUSULA, FINLAND, FINLAND 04300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERS INSTRUMENTATION INDUSTRIES, INC. 510(k) NO: K081693(TRADITIONAL)
ATTN: DORIS F WALTER PHONE NO : 412-854-1133 2990 INDUSTRIAL BLVD. SE DECISION MADE: 11-SEP-08 BETHEL PARK, PA 15102 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS INSTRUMENTATION INDUSTRIES, INC. 510(k) NO: K081778(TRADITIONAL)
ATTN: DORIS F WALTER PHONE NO : 412-854-1133 2990 INDUSTRIAL BLVD. SE DECISION MADE: 12-SEP-08 BETHEL PARK, PA 15102 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFE SUPPORT FOR TRAUMA AND TRNSPORT (LSTAT) G6 LITE INTEGRATED MEDICAL SYSTEMS, INC. 510(k) NO: K082256(TRADITIONAL)
ATTN: RENATE A MACLAREN PHONE NO : 562-498-1776 1984 OBISPO AVE. SE DECISION MADE: 26-SEP-08 SIGNAL HILL, CA 90755-1234 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZEUS SMALL CERVICAL CAGE AND LARGE, EXTRA LARGE, CURVED AND STRA INTERBODY INNOVATIONS, LLP 510(k) NO: K081614(TRADITIONAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199 1001 OAKWOOD BLVD. SE DECISION MADE: 05-SEP-08 ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SECURACATH CATHETER, MODEL SPK01 INTERRAD MEDICAL, INC. 510(k) NO: K082047(TRADITIONAL)
ATTN: SEW-WAH TAY PHONE NO : 612-801-6782 18555 37TH AVE N SE DECISION MADE: 30-SEP-08 PLYMOUTH, MN 55446 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INVENTUS IMPLANT SYSTEM INVENTUS CO., LTD 510(k) NO: K081579(TRADITIONAL)
ATTN: ROSHANA AHMED PHONE NO : 905 689 3980 4 INNOVATION DR. SE DECISION MADE: 17-SEP-08 DUNDAS, ONTARIO, CANADA L9H 7P3 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUTRITONE FACIAL EXERCISER ISOMERS LABORATORIES INC. 510(k) NO: K070250(TRADITIONAL)
ATTN: ROBERT MAZZAFERRO PHONE NO : 301-216-2720 11 DELLCASTLE COURT SE DECISION MADE: 04-SEP-08 MONTGOMERY VILLAGE,, MD 20886 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCELL TBM-R ISOTIS ORTHOBIOLOGICS, INC 510(k) NO: K081817(TRADITIONAL)
ATTN: JUDITH E O'GRADY PHONE NO : 949-595-8710 311 ENTERPRISE DRIVE SE DECISION MADE: 24-SEP-08 PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PORTABLE SUPINE PATIENT SUPPORT AND CASSETTE HOLDER JDDB MANUFACTURING, INC 510(k) NO: K081557(TRADITIONAL)
ATTN: JACQUIN C YOUNGBLOOD-JOHNSONPHONE NO : 816-914-4871 P.O. BOX 277782 SE DECISION MADE: 10-SEP-08 RIVERDALE, IL 60827-7782 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE VINYL EXAMINATION GLOVES JIANGSU ALFA GLOVE CO., LTD 510(k) NO: K081658(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 86 108 2387441 RM.1606, BLDG.1 JIANXIANG YUAN SE DECISION MADE: 30-SEP-08 NO.209, BEISI HUAN ZHONG RD. 510(k) SUMMARY AVAILABLE FROM FDA HAI DIAN DISTRICT, CHINA 100083 DEVICE: HYGEIA-5 OXYGEN CONCENTRATOR KEDL INTERNATION LIMITED 510(k) NO: K081267(TRADITIONAL)
ATTN: LEE LEICHTER PHONE NO : 239-786-1118 7690 CAMERON CIRCLE SE DECISION MADE: 23-SEP-08 FORT MYERS, FL 33912 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, M KETTENBACH GMBH & CO KG 510(k) NO: K082560(TRADITIONAL)
ATTN: MICHAELA ZINKE PHONE NO : 49 277 470558 IM HEERFELD 7 SE DECISION MADE: 08-SEP-08 ESCHENBURG, GERMANY D-35713 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN KIMBERLY-CLARK CORP. 510(k) NO: K080795(ABBREVIATED)
ATTN: DAVID M LEE PHONE NO : 770-587-7167 1400 HOLCOMB BRIDGE RD. SE DECISION MADE: 03-SEP-08 BLDG 300, #1092 510(k) SUMMARY AVAILABLE FROM FDA ROSWELL, GA 30076-2199 DEVICE: QUICKPIN LABORATORIOS GRIFOLS, S.A. 510(k) NO: K082752(TRADITIONAL)
ATTN: SEBASTIAN GASCON PHONE NO : 34 93 5710100 POL. LEVANTE C/CAN GUASCH, 2 SE DECISION MADE: 29-SEP-08 PARETS DEL VALLES, BARCELONA, SPAI510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: TEMPO CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN LIQUID, PRO LANG DENTAL MFG. CO., INC. 510(k) NO: K081514(TRADITIONAL)
ATTN: CHAH M SHEN PHONE NO : 847-215-6622 175 MESSNER DR. SE DECISION MADE: 22-SEP-08 WHEELING, IL 60090-0969 510(k) STATEMENT DEVICE: LANG DENTAL RESINCAP PATTERN AND COPING ACRYLIC RESIN LANG DENTAL MFG. CO., INC. 510(k) NO: K081705(TRADITIONAL)
ATTN: CHAH M SHEN PHONE NO : 847-215-6622 175 MESSNER DR. SE DECISION MADE: 17-SEP-08 WHEELING, IL 60090-0969 510(k) STATEMENT DEVICE: GALAXY 55 LARSEN & TOUBRO LIMITED 510(k) NO: K082685(TRADITIONAL)
ATTN: S.B. BHOSALE PHONE NO : 847-230-1070 1051 PERIMETER DRIVE SE DECISION MADE: 26-SEP-08 SUITE 470 510(k) SUMMARY AVAILABLE FROM FDA SCHAUMBURG, IL 60173 THIRD PARTY REVIEW DEVICE: SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL LEONHARD LANG GMBH 510(k) NO: K081371(TRADITIONAL)
ATTN: ELAINE DUNCAN PHONE NO : 715-549-6035 P.O. BOX 560 SE DECISION MADE: 24-SEP-08 STILLWATER, MN 55082-0560 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROLONG LIFE-TECH, INC. 510(k) NO: K081864(SPECIAL)
ATTN: JEFF KASOFF PHONE NO : 281-491-6600 4235 GREENBRIAR DR. SE DECISION MADE: 25-SEP-08 STAFFORD, TX 77477-3995 510(k) STATEMENT DEVICE: VIVASCOPE SYSTEM, MODEL 1500, 3000 LUCID, INC. 510(k) NO: K080788(TRADITIONAL)
ATTN: JAMES JOY PHONE NO : 585-239-9800 2320 BRIGHTON HENRIETTA SE DECISION MADE: 17-SEP-08 TOWNLINE RD 510(k) SUMMARY AVAILABLE FROM FDA ROCHESTER, NY 14623 DEVICE: SELECTA FAMILY OF OPHITHALMIC LASER SYSTEMS LUMENIS, INC. 510(k) NO: K081704(TRADITIONAL)
ATTN: TINA MAYER PHONE NO : 801-656-2543 3959 WEST 1820 SOUTH SE DECISION MADE: 11-SEP-08 SALT LAKE CITY, UT 84104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHOOSTENT M.I. TECH CO., LTD. 510(k) NO: K072094(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854 P.O. BOX 2007 SE DECISION MADE: 25-SEP-08 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROTA FLOW CENTRIFUGAL PUMP WITH BIOLINE COATING, MODELS BE-RF-32 MAQUET CARDIOPULMONARY AG 510(k) NO: K080470(SPECIAL)
ATTN: KATRIN SCHWEKGLENKS PHONE NO : 011 497 4789210 HECHINGER STRASSE 38 SE DECISION MADE: 12-SEP-08 HIRRLINGEN, GERMANY 72145 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HLM TUBING SET WITH BIOLINE COATING MAQUET CARDIOPULMONARY AG 510(k) NO: K080592(SPECIAL)
ATTN: KATRIN SCHWENGLENKS PHONE NO : 011 497 478921151 HECHINGER STRASSE 38 SE DECISION MADE: 11-SEP-08 HIRRLINGEN, GERMANY 72145 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RAINBOW ADHESIVE CO-OXIMETRY SENSOR, MODELS RI-25-L, RI-25, RI-2 MASIMO CORPORATION 510(k) NO: K081659(TRADITIONAL)
ATTN: MARGUERITE THOMLINSON PHONE NO : 949-297-7000 40 PARKER SE DECISION MADE: 09-SEP-08 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: K-Y BRAND INTRIGUE 2-IN-1 MASSAGE CREME MCNEIL-PPC, INC. 510(k) NO: K081236(TRADITIONAL)
ATTN: NADER FOTOUHI PHONE NO : 908-904-3730 199 GRANDVIEW ROAD SE DECISION MADE: 25-SEP-08 SKILLMAN, NJ 08558 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRO-PICC (BASIC TRAY, LONG WIRE TRAY, BASIC NURSING TRAY, FULL N MEDCOMP 510(k) NO: K081904(TRADITIONAL)
ATTN: JEAN CALLOW PHONE NO : 215-256-4201 1499 DELP DR. SE DECISION MADE: 23-SEP-08 HARLEYSVILLE, PA 19438 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMBRYOASSIST AND EMBRYOASSIST WITH PHENOL RED MEDICULT A/S 510(k) NO: K080473(TRADITIONAL)
ATTN: RONALD G LEONARDI PHONE NO : 858-586-0751 9915 CAM.CHIRIMOLLA SE DECISION MADE: 03-SEP-08 SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ICSI CUMULASE MEDICULT A/S 510(k) NO: K081639(TRADITIONAL)
ATTN: RONALD G LEONARDI PHONE NO : 858-586-0751 9915 CAM. CHIRIMOLLA SE DECISION MADE: 19-SEP-08 SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MASTERGRAFT PUTTY MEDTRONIC SOFAMOR DANEK 510(k) NO: K081784(TRADITIONAL)
ATTN: MICHELLE OBENAUER PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 17-SEP-08 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO CAPSTONE SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K082342(SPECIAL)
ATTN: CHRIS MCKEE PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 12-SEP-08 MEMPHIS, TN 38132-3576 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER C MEDTRONIC XOMED, INC. 510(k) NO: K081277(TRADITIONAL)
ATTN: ANTOINE KOUCHAKJY PHONE NO : 904-296-9600 6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 05-SEP-08 JACKSONVILLE, FL 32216 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MENICON Z RIGID GAS PERMEABLE CONTACT LENS MENICON CO. LTD. 510(k) NO: K081443(TRADITIONAL)
ATTN: BEVERLEY D VENUTI PHONE NO : 978-658-6888 269A BALLARDVALE ST. SE DECISION MADE: 23-SEP-08 WILMINGTON, MA 01887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: METACEM, META P&BOND, METACEM SILANE CERAMIC PRIMER META BIOMED CO., LTD. 510(k) NO: K081913(TRADITIONAL)
ATTN: TAE-HOON KIM PHONE NO : 82 43 2181983 414-12 MO CHOONG DONG SE DECISION MADE: 05-SEP-08 CHEUNG JU CITY, CHUNG BUK, REPUBLI510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICARDIA ANNULOPLASTY BAND DR MICARDIA CORPORATION 510(k) NO: K070488(TRADITIONAL)
ATTN: JEFFREY P DUMONTELLE PHONE NO : 949-951-4888 30 HUGHES SUITE 206 SE DECISION MADE: 04-SEP-08 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: T12S TELEMETRY TRANSMITTER MORTARA INSTRUMENT, INC. 510(k) NO: K081800(ABBREVIATED)
ATTN: LAURA SPIEGELHOFF PHONE NO : 414-354-1600 7865 NORTH 86TH ST. SE DECISION MADE: 24-SEP-08 MILWAUKEE, WI 53224 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRIMADO SURGICAL DRILL NAKANISHI, INC. 510(k) NO: K080722(TRADITIONAL)
ATTN: KEITH A BARRITT PHONE NO : 202-783-5070 1425 K STREET, N.W. SE DECISION MADE: 17-SEP-08 SUITE 1100 510(k) STATEMENT WASHINGTON, DC 20005 DEVICE: AED MONOPOLAR LAP ACCESSORIES NATIONAL ADVANCED ENDOSCOPY DEVICE510(k) NO: K081503(TRADITIONAL)
ATTN: GAYLE M BUTLER PHONE NO : 818-227-2720 22134 SHERMAN WAY SE DECISION MADE: 25-SEP-08 CANOGA PARK, CA 91303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AED BIPOLAR FORCEPS, MODEL 13-1646 NATIONAL ADVANCED ENDOSCOPY DEVICE510(k) NO: K081553(TRADITIONAL)
ATTN: GAYLE M BUTLER PHONE NO : 818-227-2720 22134 SHERMAN WAY SE DECISION MADE: 29-SEP-08 CANOGA PARK, CA 91303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KEGEL8 PELVIC EXERCISER, MODEL OPH 400 NE SERVICES LTD. 510(k) NO: K081480(TRADITIONAL)
ATTN: BRENT REIDER PHONE NO : 614-568-7000 4663 KATE LANE SE DECISION MADE: 12-SEP-08 OXFORD, OH 45056 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNIVERSAL ELECTRODES NEUROMETRIX, INC. 510(k) NO: K081871(TRADITIONAL)
ATTN: RAINER MAAS PHONE NO : 781-890-9989 62 FOURTH AVE. SE DECISION MADE: 29-SEP-08 WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO SUPEROPEN 0.23T MRI SYSTEM, MODEL NAM-P023A NEUSOFT MEDICAL SYSTEMS CO., LTD. 510(k) NO: K082485(TRADITIONAL)
ATTN: TIAN YANFANG PHONE NO : 86 24 83660649 NO.3-11, WENHUA ROAD SE DECISION MADE: 09-SEP-08 HEPING DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA SHENYANG, LIAONING, CHINA 110004 THIRD PARTY REVIEW DEVICE: SPY ANALYSIS TOOLKIT, MODEL SA9000 NOVADAQ TECHNOLOGIES, INC. 510(k) NO: K081792(TRADITIONAL)
ATTN: ALLISON MANNERS PHONE NO : 905 629 3822 2585 SKYMARK AVENUE, STE. 306 SE DECISION MADE: 17-SEP-08 MISSISSAUGA, ONTARIO, CANADA L4W 4510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MINI GHOST, MODEL: 507 NUMED, INC. 510(k) NO: K082524(SPECIAL)
ATTN: NICHELLE LAFLESH PHONE NO : 315-328-4491 2880 MAIN ST. SE DECISION MADE: 26-SEP-08 HOPKINTON, NY 12965 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUVASIVE LATERAL PLATE SYSTEM NUVASIVE, INC. 510(k) NO: K082070(SPECIAL)
ATTN: LAETITIA COUSIN PHONE NO : 858-909-1868 7475 LUSK BLVD SE DECISION MADE: 24-SEP-08 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PARKONE OCULUS OPTIKGERATE GMBH 510(k) NO: K073508(TRADITIONAL)
ATTN: JOERG IWANCZUK PHONE NO : MUNCHHOLZHAUSER STR. 29 SE DECISION MADE: 11-SEP-08 WETZLAR, GERMANY D-35582 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OLYMPUS TOTAL BHCG TEST SYSTEN OLYMPUS LIFE SCIENCE RESEARCH EURO510(k) NO: K080094(TRADITIONAL)
ATTN: STEPHANIE DONNELLY PHONE NO : 972-317-8857 3131 WEST ROYAL LANE SE DECISION MADE: 03-SEP-08 IRVING, TX 75063 510(k) STATEMENT DEVICE: OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181 OLYMPUS LIFE SCIENCE RESEARCH EURO510(k) NO: K080435(TRADITIONAL)
ATTN: STEPHANIE G DONNELLY PHONE NO : 469-230-0959 3500 CORPORATE PKWAY SE DECISION MADE: 05-SEP-08 CENTER VALLEY, PA 18034 510(k) STATEMENT DEVICE: HD ENDOEYE LAPARO-THORACO VIDEOSCOPE OLYMPUS LTF TYPE VH OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K080948(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 484-896-5688 3500 CORPORATE PARKWAY SE DECISION MADE: 26-SEP-08 PO BOX 610 510(k) SUMMARY AVAILABLE FROM FDA CENTER VALLEY, PA 18034-0610 DEVICE: PASCAL SYNTHESIS DELIVERY SYSTEM OPTIMEDICA CORPORATION 510(k) NO: K081744(TRADITIONAL)
ATTN: JUDY F GORDON PHONE NO : 949-715-0609 733 BOLSANA DRIVE SE DECISION MADE: 09-SEP-08 LAGUNA BEACH, CA 92651 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DAMON 4CLEAR ORMCO CORP. 510(k) NO: K081415(TRADITIONAL)
ATTN: WENDY GARMAN PHONE NO : 714-516-7602 1717 WEST COLLINS AVENUE SE DECISION MADE: 24-SEP-08 ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STARLIGHT ORTHOMERICA PRODUCTS, INC. 510(k) NO: K081994(TRADITIONAL)
ATTN: ALAN T SANDIFER PHONE NO : 407-290-6592 6333 N. ORANGE BLOSSOM TRAIL SE DECISION MADE: 12-SEP-08 ORLANDO, FL 32810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSSTELL ISQ IMPLANT STABILITY METER OSSTELL AB 510(k) NO: K082523(SPECIAL)
ATTN: CHERITA JAMES PHONE NO : 703-562-9800 901 KING STREET SE DECISION MADE: 26-SEP-08 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA ALEXANDRIA, VA 22314 DEVICE: MS SYSTEM (NARROW RIDGE) OSSTEM IMPLANT CO.,LTD 510(k) NO: K080594(TRADITIONAL)
ATTN: MINJOO KIM PHONE NO : 215-736-2990 ONE BEN FAIRLESS DR. SE DECISION MADE: 03-SEP-08 FAIRLESS HILLS, PA 19030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HU/HS/HG PROSTHETIC SYSTEM OSSTEM IMPLANT CO.,LTD 510(k) NO: K081575(TRADITIONAL)
ATTN: MINJOO KIM PHONE NO : 267-759-7044 85 BEN FAIRLESS DR. SE DECISION MADE: 02-SEP-08 FAIRLESS HILLS, PA 19030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMOOTHKIT+ OSYRIS 510(k) NO: K082004(SPECIAL)
ATTN: JAOUAD ZEMMOURI PHONE NO : 33 032 0675997 121 RUE CHANZY, BP 90140 SE DECISION MADE: 26-SEP-08 HELLEMMES , FRANCE, FRANCE F59260 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDIOP-B SYSTEM, VERSION 2.1 WITH LVA PAIEON, INC. 510(k) NO: K073328(TRADITIONAL)
ATTN: RAVIT BARKAMA PHONE NO : 972 3 9150000 22 HAMELACHA ST., P.O.B. 11355 SE DECISION MADE: 09-SEP-08 ROSH HAAYIN, ISRAEL 48901 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLANISIGHT LINASYS PATHFINDER THERAPEUTICS, INC. 510(k) NO: K082228(TRADITIONAL)
ATTN: JAMES D STEFANSIC PHONE NO : 615-783-0094 2969 ARMORY DRIVE SE DECISION MADE: 22-SEP-08 SUITE 100A 510(k) SUMMARY AVAILABLE FROM FDA NASHVILLE, TN 37204 DEVICE: ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UK PENTAX MEDICAL COMPANY 510(k) NO: K081518(TRADITIONAL)
ATTN: PAUL SILVA PHONE NO : 800-431-5880 102 CHESTNUT RIDGE RD. SE DECISION MADE: 05-SEP-08 MONTVALE, NJ 07645-1856 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVANTE Z ZIRCONIA (AS)3 BLOCKS PENTRON CERAMICS, INC. 510(k) NO: K081749(TRADITIONAL)
ATTN: CINDY SALTER PHONE NO : 732-563-4755 500 MEMORIAL DR. SE DECISION MADE: 30-SEP-08 SOMERSET, NJ 08873 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEU PETER LAZIC GMBH 510(k) NO: K081489(TRADITIONAL)
ATTN: FRANZ MENEAN PHONE NO : 49 746 3995411 GRIESWEG 47 SE DECISION MADE: 25-SEP-08 MUHLHEIM, BADEN-WURTTEMBERG, GERMA510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VEO MULTIGAS MONITOR FOR POCKET PC PHASEIN AB 510(k) NO: K081601(TRADITIONAL)
ATTN: DAVID WEISSBURG PHONE NO : 608-770-0223 4213 WINNEQUAH DR. SE DECISION MADE: 04-SEP-08 MADISON, WI 53716 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO FETCH ASPIRATION CATHETER POSSIS MEDICAL, INC. 510(k) NO: K081989(SPECIAL)
ATTN: MIKE BURNSIDE PHONE NO : 763-780-4555 9055 EVERGREEN BLVD., N.W. SE DECISION MADE: 26-SEP-08 MINNEAPOLIS, MN 55433-8003 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PULPDENT TEMPORARY CROWN AND BRIDGE MATERIAL PULPDENT CORPORATION 510(k) NO: K081810(TRADITIONAL)
ATTN: KENNETH J BERK PHONE NO : 617-926-6666 80 OAKLAND ST. SE DECISION MADE: 17-SEP-08 P.O. BOX 780 510(k) SUMMARY AVAILABLE FROM FDA WATERTOWN, MA 02472 DEVICE: TXRX 15CH KNEE COIL (1.5T AND 3T), TXRX CP EXTREMITY COIL 3T QUALITY ELECTRODYNAMICS 510(k) NO: K082636(TRADITIONAL)
ATTN: PHONE NO : 777 BETA DR. SE DECISION MADE: 25-SEP-08 MAYFIELD VILLAGE, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: HYDROMETIC FOAM QUINNOVA PHARMACEUTICALS 510(k) NO: K070309(TRADITIONAL)
ATTN: JEFFREY DAY PHONE NO : 215-860-6263 301SOUTH STATE STREET SE DECISION MADE: 12-SEP-08 SUITE NOO1 510(k) SUMMARY AVAILABLE FROM FDA NEWTOWN, PA 18940 DEVICE: RAYNER SINGLE USE SMALL INCISION DISPOSABLE INJECTOR, MODEL R-IN RAYNER SURGICAL INC 510(k) NO: K081455(TRADITIONAL)
ATTN: ANDREW WELLS PHONE NO : 44 127 3205401 SACKVILLE ROAD SE DECISION MADE: 05-SEP-08 HOVE, EAST SUSSEX, UNITED KINGDOM 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RAYPAX SYSTEM RAYPAX, INC. 510(k) NO: K081948(TRADITIONAL)
ATTN: CHRIS CHUNG PHONE NO : 562-921-8640 14251 E. FIRESTONE BLVD. SE DECISION MADE: 19-SEP-08 LA MIRADA, CA 90638 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GOLOX-93 RESPIRONICS, INC. 510(k) NO: K081779(TRADITIONAL)
ATTN: ZITA A YURKO PHONE NO : 724-387-4120 1740 GOLDEN MILE HIGHWAY SE DECISION MADE: 19-SEP-08 MONROEVILLE, PA 15146 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VER RICH MOUNTAIN MEDICAL PRODUCTS, IN510(k) NO: K081539(ABBREVIATED)
ATTN: MICHELLE SHIH PHONE NO : 886 2 66003631 NO. 8, JIANG YIN ROAD SE DECISION MADE: 26-SEP-08 YI TANG TOWNSHIP 510(k) SUMMARY AVAILABLE FROM FDA PIZHOU, JIANGSU, CHINA DEVICE: DISPOSABLE SYNTHETIC EXAMINATION GLOVES, POWDER FREE RICH MOUNTAIN MEDICAL PRODUCTS, IN510(k) NO: K082443(TRADITIONAL)
ATTN: MICHELLE SHIH PHONE NO : 886 2 66003631 NO. 8, JIANG YIN ROAD SE DECISION MADE: 26-SEP-08 YI TANG TOWNSHIP 510(k) SUMMARY AVAILABLE FROM FDA PIZHOU, JIANGSU, CHINA DEVICE: DISPOSABLE VINYL EXAMINATION GLOVE, POWDERED RICH MOUNTAIN MEDICAL PRODUCTS, IN510(k) NO: K082444(TRADITIONAL)
ATTN: MICHELLE SHIH PHONE NO : 886 2 66003631 NO. 8, JIANG YIN ROAD SE DECISION MADE: 30-SEP-08 YI TANG TOWNSHIP 510(k) SUMMARY AVAILABLE FROM FDA PIZHOU, JIANGSU, CHINA DEVICE: ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL A ROCHE DIAGNOSTICS 510(k) NO: K081338(TRADITIONAL)
ATTN: STEPHANIE GREEMAN PHONE NO : 317-521-2458 9115 HAGUE RD. SE DECISION MADE: 11-SEP-08 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LAPAROSCOPIC AND ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES, LA RUDOLF MEDICAL GMBH + CO. KG 510(k) NO: K073498(TRADITIONAL)
ATTN: FRANZ MENEAN PHONE NO : 049 746 3995411 GRIESWEG 47 SE DECISION MADE: 19-SEP-08 MUHLHEIM, BADEN-WURTTEMBERG, GERMA510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARBOXYLATE CEM, PHOSPHATE CEM S & C POLYMER GMBH 510(k) NO: K081702(TRADITIONAL)
ATTN: CHRISTIAN BOETTCHER PHONE NO : 004 941 214830 ROBERT-BOSCH-STRASSE 5 SE DECISION MADE: 05-SEP-08 ELMSHORN, GERMANY D-25335 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUPRAMESH EXTRA S. JACKSON, INC. 510(k) NO: K080216(TRADITIONAL)
ATTN: NORMAN R ESTRIN PHONE NO : 301-279-2899 9109 COPERHAVER DR SE DECISION MADE: 15-SEP-08 POTOMAC, MD 20854 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RMX PHYSIOLOGICAL DATA RECORDER S.L.P. LTD. 510(k) NO: K080375(TRADITIONAL)
ATTN: NOAM HADAS PHONE NO : 972 3 5371281 62 ANILEVITCH ST. SE DECISION MADE: 02-SEP-08 TEL-AVIV, ISRAEL 67060 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: INFRARED EAR THERMOMETER, MODEL ET-101A SEJOY ELECTRONICS & INSTRUMENTS CO510(k) NO: K082192(ABBREVIATED)
ATTN: REN YUNHUA PHONE NO : 86 571 81957767 4TH FLOOR, B2 BUILDING SE DECISION MADE: 17-SEP-08 FENG-TAN-LU INDUSTRIAL ZONE 510(k) SUMMARY AVAILABLE FROM FDA HANGZHOU, ZHEJIANG, CHINA 310030 THIRD PARTY REVIEW DEVICE: CONTURA LUMEN MARKER SENORX, INC. 510(k) NO: K082264(TRADITIONAL)
ATTN: EBEN GORDON PHONE NO : 949-362-4800 11 COLUMBIA SE DECISION MADE: 12-SEP-08 ALISO VIEJO, CA 92656 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SERIM DISINTEK OPA TEST STRIP SERIM RESEARCH CORP. 510(k) NO: K082352(TRADITIONAL)
ATTN: PATRICIA A RUPCHOCK PHONE NO : 574-264-3440 3506 REEDY DRIVE SE DECISION MADE: 25-SEP-08 P.O. BOX 4002 510(k) SUMMARY AVAILABLE FROM FDA ELKHART, IN 46514 DEVICE: WEIGAO EMPTY CARTRIDGE SYRINGE SHANDONG WEIGAO GROUP MEDICAL POLY510(k) NO: K081241(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 86 216 4264467 SUITE 8D, NO.19, LANE 999 SE DECISION MADE: 08-SEP-08 ZHONGSHAN NO.2 ROAD(S) 510(k) SUMMARY AVAILABLE FROM FDA SHANGHAI, CHINA 200030 DEVICE: ABSORBABLE SYNTHETIC SUTURE WITH NEEDLE ATTACHMENT (PGA BRAIDED) SHANGHAI PUDONG JINHUAN MEDICAL PR510(k) NO: K080412(TRADITIONAL)
ATTN: BRANDON CHOI PHONE NO : 562-943-4262 FLEMINGTON CT SE DECISION MADE: 04-SEP-08 #155 510(k) SUMMARY AVAILABLE FROM FDA LA MIRADA, CA 90638 DEVICE: NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH POLYMER SIAM SEMPERMED CORP. LTD. 510(k) NO: K081907(ABBREVIATED)
ATTN: WILLIAM E HARRIS PHONE NO : 727-787-7250 13900 49TH STREET NORTH SE DECISION MADE: 03-SEP-08 CLEARWATER, FL 33762 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NON-STERILE, POWDERED LATEX EXAMINATION GLOVE SIAM SEMPERMED CORP. LTD. 510(k) NO: K081910(ABBREVIATED)
ATTN: JOHN CALHOUN PHONE NO : 727-787-0880 13900 49TH STREET NORTH SE DECISION MADE: 17-SEP-08 CLEARWATER, FL 33762 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K081013(TRADITIONAL)
ATTN: LIBBY WARRINER PHONE NO : 916-374-3244 2040 ENTERPRISE BLVD. SE DECISION MADE: 08-SEP-08 WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) FLE SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K082645(SPECIAL)
ATTN: VICTOR M CARRIO PHONE NO : 302-631-0376 MS 514, PO BOX 6101 SE DECISION MADE: 22-SEP-08 NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K081789(TRADITIONAL)
ATTN: HELEN M LEE PHONE NO : 305-631-8706 500 GBC DRIVE SE DECISION MADE: 10-SEP-08 MS 514 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR SIEMENS MEDICAL SOLUTIONS DIAGNOST510(k) NO: K071455(TRADITIONAL)
ATTN: MARY SEEGER PHONE NO : 914-524-2908 511 BENEDICT AVENUE SE DECISION MADE: 11-SEP-08 TARRYTOWN, NY 10591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUNAV V ULTRASOUND CATHETER SIEMENS MEDICAL SOLUTIONS USA INC.510(k) NO: K081808(SPECIAL)
ATTN: SHELLY PEARCE PHONE NO : 650-694-5968 1230 SHOREBIRD WAY SE DECISION MADE: 26-SEP-08 P.O. BOX 7393 510(k) SUMMARY AVAILABLE FROM FDA MOUNTAIN VIEW, CA 94039-7393 DEVICE: SIMPACT IMPLANT SYSTEM SIMPACT LLC 510(k) NO: K081226(TRADITIONAL)
ATTN: ALAN LOMBARDO PHONE NO : 973-698-1128 300 INTERPACE PARKWAY SE DECISION MADE: 12-SEP-08 BUILDING C 3RD FLOOR 510(k) SUMMARY AVAILABLE FROM FDA PARSIPPANY, NJ 07054 DEVICE: SMITH & NEPHEW, INC., PROMOS REVERSE SHOULDER SYSTEM SMITH & NEPHEW, INC. 510(k) NO: K081016(TRADITIONAL)
ATTN: JASON SELLS PHONE NO : 901-399-5520 1450 E BROOKS ROAD SE DECISION MADE: 05-SEP-08 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RENASYS EZ SMITH & NEPHEW, INC. 510(k) NO: K082426(SPECIAL)
ATTN: LAURA KREJCI PHONE NO : 727-329-7702 970 LAKE CARILLON DR. SE DECISION MADE: 05-SEP-08 SUITE 110 510(k) SUMMARY AVAILABLE FROM FDA ST. PETERSBURG, FL 33716 DEVICE: PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM HEXALOBULAR BONE SC SMITH & NEPHEW, INC. 510(k) NO: K082516(SPECIAL)
ATTN: LAURA SEJNOWSKI PHONE NO : 901-399-5349 1450 BROOKS RD. SE DECISION MADE: 17-SEP-08 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TU SMITHS MEDICAL ASD, INC. 510(k) NO: K081440(TRADITIONAL)
ATTN: BARBARA LAW PHONE NO : 614-791-5568 6250 SHIER RINGS RD. SE DECISION MADE: 12-SEP-08 DUBLIN, OH 43016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 4CIS SOLAR AND APOLLON SPINE SYSTEMS SOLCO BIOMEDICAL CO., LTD. 510(k) NO: K082453(SPECIAL)
ATTN: SAEYOUNG AHN PHONE NO : 240-499-4290 155 GIBBS ST. SE DECISION MADE: 23-SEP-08 SUITE 510 510(k) SUMMARY AVAILABLE FROM FDA ROCKVILLE, MD 20850 DEVICE: SOLX 790 TITANIUM SAPPHIRE LASER SOLX INC. 510(k) NO: K081774(TRADITIONAL)
ATTN: DOUG ADAMS PHONE NO : 781-547-4050 890 WINTER ST., SUITE 115 SE DECISION MADE: 12-SEP-08 WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOMNOWATCH SOMNOMEDICS GMBH 510(k) NO: K081485(TRADITIONAL)
ATTN: CHERITA JAMES PHONE NO : 703-562-9800 901 KING STREET SE DECISION MADE: 18-SEP-08 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA ALEXANDRIA, VA 22314 DEVICE: LUCENT MAGNUM+ SPINAL ELEMENTS, INC. 510(k) NO: K081711(TRADITIONAL)
ATTN: KERRI DIMARTINO PHONE NO : 760-607-1816 2744 LOKER AVE. W. SUITE 100 SE DECISION MADE: 11-SEP-08 CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EPICOR ABLATION CONTROL SYSTEM, MODEL ACS-US-2, ACS-EUR-2 ST. JUDE MEDICAL 510(k) NO: K082279(SPECIAL)
ATTN: DONNA R LUNAK PHONE NO : 651-632-9454 240 SANTA ANA COURT SE DECISION MADE: 16-SEP-08 SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENSITE FUSION DYNAMIC REGISTRATION TOOL ST. JUDE MEDICAL 510(k) NO: K082467(TRADITIONAL) ATTN: KAREN J MCKELVEY PHONE NO : 651-632-9454 1350 ENERGY LN., SUITE 110 SE DECISION MADE: 11-SEP-08 ST. PAUL, MN 55108 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: RESERT XL HLD HIGH LEVEL DISINFECTANT STERIS CORPORATION 510(k) NO: K080420(TRADITIONAL)
ATTN: JOHN R SCOVILLE JR. PHONE NO : 440-392-7330 5960 HEISLEY RD. SE DECISION MADE: 02-SEP-08 MENTOR, OH 44060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INREACH PLANNING LAPTOP SUPERDIMENSION, LTD. 510(k) NO: K082386(SPECIAL)
ATTN: MARGARET DEPUYDT PHONE NO : 763-210-4052 161 CHESHIRE LANE NORTH, SE DECISION MADE: 16-SEP-08 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA MINNEAPOLIS, MN 55441-5433 DEVICE: SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K073478(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484 1717 W. COLLINS AVE. SE DECISION MADE: 03-SEP-08 ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPS SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K080089(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484 1717 W. COLLINS AVE. SE DECISION MADE: 04-SEP-08 ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MATRIX RF APPLICATOR SYNERON MEDICAL LTD. 510(k) NO: K073572(TRADITIONAL)
ATTN: YONI IGER PHONE NO : 972 732 442200 P.O. BOX 550 SE DECISION MADE: 17-SEP-08 INDUSTRIAL ZONE 510(k) SUMMARY AVAILABLE FROM FDA YOKNEAM ILLIT, ISRAEL 20692 DEVICE: SYNTHES RIB FIXATION SYSTEM SYNTHES (USA) 510(k) NO: K081623(TRADITIONAL)
ATTN: AMNON TALMOR PHONE NO : 610-719-6604 1301 GOSHEN PKWY SE DECISION MADE: 08-SEP-08 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM SYNTHES (USA) 510(k) NO: K081747(TRADITIONAL)
ATTN: ANDREA M TASKER PHONE NO : 610-719-6920 1301 GOSHEN PKWY SE DECISION MADE: 05-SEP-08 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANTEGRA-T SYNTHES SPINE CO.LP 510(k) NO: K081568(TRADITIONAL)
ATTN: KIRSTEN STOWELL PHONE NO : 610-719-5534 1302 WRIGHTS LANE EAST SE DECISION MADE: 02-SEP-08 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADAPT UNIVERSAL LAPAROSCOPIC PORT, MODEL 405940, 405912, 4059121 TELEFLEX MEDICAL 510(k) NO: K082156(SPECIAL)
ATTN: ANGELA BOUSE PHONE NO : 919-433-4904 2917 WECK DR. SE DECISION MADE: 10-SEP-08 RESEARCH TRIANGLE PARK, NC 27709 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURSHIELD SAFETY I.V. CATHETER TERUMO MEDICAL CORP. 510(k) NO: K082362(TRADITIONAL)
ATTN: EILEEN DORSEY PHONE NO : 410-392-7241 950 ELKTON BLVD. SE DECISION MADE: 17-SEP-08 ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: FINECROSS MG CORONARY MICRO-GUIDE CATHETER TERUMO MEDICAL CORP. 510(k) NO: K082519(TRADITIONAL)
ATTN: MARK UNTERREINER PHONE NO : 410-392-7213 950 ELKTON BLVD. SE DECISION MADE: 26-SEP-08 ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: GLIDESHEATH TERUMO MEDICAL CORP. 510(k) NO: K082644(TRADITIONAL)
ATTN: PHONE NO : 950 ELKTON BLVD. SE DECISION MADE: 18-SEP-08 ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER TERUMO MEDICAL CORP. 510(k) NO: K082736(TRADITIONAL)
ATTN: MARK UNTERREINER PHONE NO : 410-392-7213 950 ELKTON BLVD. SE DECISION MADE: 24-SEP-08 ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: DUOFLO CATHETER THERMOPEUTIX INC. 510(k) NO: K080700(TRADITIONAL)
ATTN: PHONE NO : 9925B BUSINESS PARK AVE. SE DECISION MADE: 26-SEP-08 SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: IMAGENET PROFESSIONAL PC SOFTWARE SYSTEM OR IMAGENET PROFESSIONA TOPCON CORP. 510(k) NO: K082364(TRADITIONAL)
ATTN: BARBARA S FANT, PHARM.D. PHONE NO : 513-961-8200 310 TERRACE AVENUE SE DECISION MADE: 30-SEP-08 SUITE 201 510(k) SUMMARY AVAILABLE FROM FDA CINCINNATI, OH 45220 THIRD PARTY REVIEW DEVICE: MAXIM PLASTIC APPLICATOR & NON-APPLICATOR TAMPONS TOSAMA D.D. 510(k) NO: K080775(TRADITIONAL)
ATTN: ANTONIJA VIDENSEK PHONE NO : 386 01 7290370 SARANOVICEVA CESTA 035 SE DECISION MADE: 10-SEP-08 VIR, DOMZALE, SLOVENIA 1230 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: DRAD3000E/RADREX-I TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K082494(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000 2441 MICHELLE DR. SE DECISION MADE: 12-SEP-08 P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA TUSTIN, CA 92781-2068 THIRD PARTY REVIEW DEVICE: ULTRAEXTEND USWS-900A TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K082596(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000 2441 MICHELLE DR. SE DECISION MADE: 23-SEP-08 P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA TUSTIN, CA 92781-2068 THIRD PARTY REVIEW DEVICE: G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8 TOSOH BIOSCIENCE, INC. 510(k) NO: K071132(TRADITIONAL)
ATTN: CHARLES P GILL PHONE NO : 800-248-6764 6000 SHORELINE COURT SE DECISION MADE: 16-SEP-08 SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA SOUTH SAN FRANCISCO, CA 94080 DEVICE: 21.3-INCH (54CM) MONOCHROME LCD MONITOR MS21I2 (MDL2127A) TOTOKU ELECTRIC CO., LTD 510(k) NO: K081945(TRADITIONAL)
ATTN: MIKIO HASEGAWA PHONE NO : 81 268 345469 300 OYA, UEDA SE DECISION MADE: 12-SEP-08 NAGANO, JAPAN 386-0192 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM TRANSONIC SYSTEMS, INC. 510(k) NO: K080116(TRADITIONAL)
ATTN: MARK S ALSBERGE PHONE NO : 607-257-5300 34 DUTCH MILL RD. SE DECISION MADE: 08-SEP-08 WARREN RD. BUSINESS PARK 510(k) SUMMARY AVAILABLE FROM FDA ITHACA, NY 14850 DEVICE: CVUE ADVANCED (HIOXIFILCON D) SOFT (HYDROPHILIC) CONTACT LENS UNILENS CORP., USA 510(k) NO: K082393(SPECIAL)
ATTN: ALAN J FRAZER PHONE NO : 727-544-2531 10431 72ND ST. NORTH SE DECISION MADE: 11-SEP-08 LARGO, FL 33777 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: "UNITED" U2 PATELLA UNITED ORTHOPEDIC CORP. 510(k) NO: K082469(SPECIAL)
ATTN: RUDY CHEN PHONE NO : 886 3 5773351 57 PARK AVE. 2, SCIENCE PARK SE DECISION MADE: 26-SEP-08 HSINCHU, CHINA (TAIWAN) 300 510(k) STATEMENT DEVICE: MODIFICATION TO PREFERENCE PEDICLE SCREW SYSTEM US SPINE 510(k) NO: K081883(TRADITIONAL)
ATTN: RICHARD JANSEN PHONE NO : 952-431-5999 13540 GUILD AVE SE DECISION MADE: 24-SEP-08 APPLE VALLEY, MN 55124 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GILRAS SLIT LAMP, MODELS GR-SL7, GR-SL36, GR-SL54 AND GR-SL72 USOPHTHALMIC, LLC 510(k) NO: K080776(TRADITIONAL)
ATTN: AL WEISENBORN PHONE NO : 395-829-3437 7255 NW 88TH STREET SE DECISION MADE: 09-SEP-08 UNIT 9 510(k) SUMMARY AVAILABLE FROM FDA MIAMI, FL 33166 DEVICE: FLOWPICC STYLET VASONOVA INC. 510(k) NO: K081625(TRADITIONAL)
ATTN: SORIN GRUNWALD PHONE NO : 650-269-8444 1368 BORDEAUX DR., SUITE 100 SE DECISION MADE: 26-SEP-08 SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OCTANE VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM VERTIFLEX, INC. 510(k) NO: K082270(SPECIAL)
ATTN: STEVE REITZLER PHONE NO : 949-940-1434 1351 CALLE AVANZADO SE DECISION MADE: 16-SEP-08 SAN CLEMENTE, CA 92673 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: G-1 V5 VITROLIFE SWEDEN AB 510(k) NO: K081114(TRADITIONAL)
ATTN: KJELL KJORK PHONE NO : 46 31 7218077 FAKTORVAGEN 13 SE DECISION MADE: 16-SEP-08 KUNGSBACKA, SWEDEN SE-434 37 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: G-MOPS G5 SERIES VITROLIFE SWEDEN AB 510(k) NO: K081115(TRADITIONAL)
ATTN: KJELL KJORK PHONE NO : 46 31 7218077 FAKTORVAGEN 13 SE DECISION MADE: 17-SEP-08 KUNGSBACKA, SWEDEN SE-434 37 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: G-IVF G5 SERIES VITROLIFE SWEDEN AB 510(k) NO: K081116(TRADITIONAL)
ATTN: KJELL KJORK PHONE NO : 46 31 7218077 FAKTORVAGEN 13 SE DECISION MADE: 02-SEP-08 KUNGSBACKA, SWEDEN SE-434 37 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: G-2 V5 VITROLIFE SWEDEN AB 510(k) NO: K081117(TRADITIONAL)
ATTN: KJELL KJORK PHONE NO : 46 31 7218077 FAKTORVAGEN 13 SE DECISION MADE: 16-SEP-08 KUNGSBACKA, SWEDEN SE-434 37 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZENO AI ECO DISC WIELAND DENTAL + TECHNIK GMBH & CO510(k) NO: K082257(TRADITIONAL)
ATTN: GERHARD POLZER PHONE NO : 490 723 13705219 SCHWENNINGER STRABE 13 SE DECISION MADE: 18-SEP-08 PFORZHEIM, GERMANY D-75179 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHARLOTTE LISFRANC BONE SCREW, CHARLOTTE LISFRANC PLATE WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K081374(TRADITIONAL)
ATTN: SARAH HOLTGREWE PHONE NO : 901-867-4476 5677 AIRLINE RD. SE DECISION MADE: 09-SEP-08 ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VASCUTRAK 2, MODELS: V14 AND V18 YMED INC. 510(k) NO: K082343(SPECIAL)
ATTN: THOMAS SCHROEDER PHONE NO : 858-549-1337 9951-B BUSINESS PARK AVE. SE DECISION MADE: 11-SEP-08 SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GONGDONG DISPOSABLE SHARP CONTAINER ZHEJIANG GONGDONG MEDICAL PLASTIC 510(k) NO: K082042(TRADITIONAL)
ATTN: WEIFENG ZHONG PHONE NO : 86 576 84081133 BEICHENG INDUSTRIAL AREA SE DECISION MADE: 03-SEP-08 HUANGYAN, TAIZHOU, ZHEJIANG, CHINA510(k) STATEMENT DEVICE: ZIMMER PATIENT-SPECIFIC CERAMIC ABUTMENT ZIMMER DENTAL INC. 510(k) NO: K080164(TRADITIONAL)
ATTN: ERIN MCVEY PHONE NO : 760-929-4166 1900 ASTON AVE. SE DECISION MADE: 25-SEP-08 CARLSBAD, CA 92008-7308 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIMMER SEGMENTAL SYSTEM VARIABLE STIFFNESS STEM EXTENSIONS AND I ZIMMER, INC. 510(k) NO: K081860(TRADITIONAL)
ATTN: TONI KINGSLEY PHONE NO : 574-372-4485 P.O. BOX 708 SE DECISION MADE: 26-SEP-08 WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BISQUE ZIRCONIA BLANKS, TYPE BYZ ZIRCAR ZIRCONIA, INC. 510(k) NO: K081850(TRADITIONAL)
ATTN: STUART R GOLDMAN PHONE NO : 512-327-9997 1705 S. CAPITAL OF TEXAS HWY SE DECISION MADE: 25-SEP-08 SUITE 500 510(k) SUMMARY AVAILABLE FROM FDA AUSTIN, TX 78746 DEVICE: ZOLL R SERIES ZOLL MEDICAL CORPORATION 510(k) NO: K081574(TRADITIONAL)
ATTN: EILEEN M BOYLE PHONE NO : 978-421-9171 269 MILL ROAD SE DECISION MADE: 18-SEP-08 CHELMSFORD, MA 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 266 TOTAL WITH SUMMARIES 252 TOTAL WITH STATEMENTS 14
Updated October 6, 2008
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