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Medical Devices
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September 2008 510(k) Clearances
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE)
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD 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
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