SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE)
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD 01-OCT-2006 THROUGH 31-OCT-2006
DEVICE: UNICEM
3M ESPE DENTAL PRODUCTS 510(k) NO: K062292(TRADITIONAL)
ATTN: SABINE KRISCHER PHONE NO : 011 498 1527001238
ESPE PLATZ SE DECISION MADE: 25-OCT-06
SEEFELD, BAVARIA, GERMANY D-82229 510(k) STATEMENT
DEVICE: CLARITY MODIFIED CERAMIC BRACKETS
3M UNITEK 510(k) NO: K062305(TRADITIONAL)
ATTN: L MARLYN SCHEFF PHONE NO : 626-574-4496
2724 SOUTH PECK RD. SE DECISION MADE: 18-OCT-06
MONROVIA, CA 91016 510(k) STATEMENT
DEVICE: AUDIT MICROCV IMMUNOASSAY LINEARITY SET
AALTO SCIENTIFIC LTD. 510(k) NO: K062668(TRADITIONAL)
ATTN: ALAN VEKICH PHONE NO : 760-431-7922
1959 KELLOGG AVE. SE DECISION MADE: 16-OCT-06
CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODULAR LAPAROSCOPY ACCESSORIES, HANDLE; SISSORS (STRAIGHT AND C
AARON MEDICAL INDUSTRIES 510(k) NO: K062337(TRADITIONAL)
ATTN: RICHARD A KOZLOFF PHONE NO : 727-803-8513
7100 30TH AVE. NORTH SE DECISION MADE: 05-OCT-06
ST. PETERSBURG, FL 33710-2902 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FOX SV PTA CATHETER
ABBOTT LABORATORIES 510(k) NO: K062843(SPECIAL)
ATTN: KATHRYN MARCHEL PHONE NO : 650-474-6341
400 SAGINAW DRIVE SE DECISION MADE: 17-OCT-06
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROENDOSCOPE
ACCLARENT, INC. 510(k) NO: K063078(TRADITIONAL)
ATTN: DEBBIE COGAN PHONE NO : 650-687-5857
1525-B O'BRIEN DR. SE DECISION MADE: 24-OCT-06
MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
ACCURAY, INC. 510(k) NO: K062967(SPECIAL)
ATTN: ANNE SCHLAGENHAFT PHONE NO : 408-716-4628
1310 CHESAPEAKE TERRACE SE DECISION MADE: 30-OCT-06
SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACRYDERM SILVER ANTIMICROBIAL THIN FILM, MODEL 2006
ACRYMED, INC. 510(k) NO: K061232(TRADITIONAL)
ATTN: BRUCE GIBBINS PHONE NO : 503-624-9830
9560 SW NIMBUS AVE SE DECISION MADE: 06-OCT-06
BEAVERTON, OR 97008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STA CATH ATTACHABLE INFISION CATHETER, MODEL STA20
ADVANCED INFUSION, INC. 510(k) NO: K061661(TRADITIONAL)
ATTN: JAMES CHRISTENSEN PHONE NO : 909-394-4916
466 WEST ARROW HWY., UNIT H SE DECISION MADE: 18-OCT-06
SAN DIMAS, CA 91773 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIVERSAL SPINAL ANTERIOR LOCKING PLATE SYSTEM
ADVANCED SPINE TECHNOLOGY, INC. 510(k) NO: K062686(SPECIAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD. SE DECISION MADE: 05-OCT-06
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM
ADVANCED STERILIZATION PRODUCTS 510(k) NO: K061899(TRADITIONAL)
ATTN: JOSEPH M ASCENZI PHONE NO : 949-453-6352
33 TECHNOLOGY DR. SE DECISION MADE: 26-OCT-06
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C. ALBICANS PNA FISH
ADVANDX, INC. 510(k) NO: K062461(TRADITIONAL)
ATTN: AMY AULWES PHONE NO : 781-329-2993
690 CANTON STREET, SUITE 302 SE DECISION MADE: 25-OCT-06
WESTWOOD, MA 02090 510(k) STATEMENT
DEVICE: CR 85-X
AGFA CORPORATION 510(k) NO: K062742(SPECIAL)
ATTN: JUDITH HARBOUR PHONE NO : 864-421-1912
10 SOUTH ACADEMY ST. SE DECISION MADE: 13-OCT-06
GREENVILLE, SC 29601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KOZY COMFORT INFANT POSITIONER
ALFRED E MANN INST. FOR BIOMEDICAL510(k) NO: K062143(TRADITIONAL)
ATTN: ARMAN H NADERSHAHI PHONE NO : 213-740-8271
1042 DOWNEY WAY, DRB 101 SE DECISION MADE: 24-OCT-06
LOS ANGELES, CA 90089-1112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESUSCITATION TIMER, MODEL L770-CPR
ALLIED HEALTHCARE PRODUCTS, INC. 510(k) NO: K062080(TRADITIONAL)
ATTN: WAYNE KARCHER PHONE NO : 314-771-2400
1720 SUBLETTE AVE. SE DECISION MADE: 18-OCT-06
ST.LOUIS, MO 63110 510(k) STATEMENT
DEVICE: AMBU WHITE SENSOR CFM, CFL
AMBU A/S 510(k) NO: K052944(TRADITIONAL)
ATTN: SANJAY PARIKH PHONE NO : 410-768-6464
6740 BAYMEADOW DR. SE DECISION MADE: 25-OCT-06
GLEN BURNIE, MD 21060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMBU BLUE SENSOR NEO AND NEO X
AMBU A/S 510(k) NO: K053550(TRADITIONAL)
ATTN: SANJAY PARIKH PHONE NO : 410-768-6464
6740 BAYMEADOW DR. SE DECISION MADE: 25-OCT-06
GLEN BURNIE, MD 21060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DBEST HCG PANEL TEST KIT
AMERITEK USA, INC. 510(k) NO: K061257(TRADITIONAL)
ATTN: K C YEE PHONE NO : 425-379-2580
125 130 ST. SE, SE DECISION MADE: 13-OCT-06
#200 510(k) SUMMARY AVAILABLE FROM FDA
EVERETT, WA 98208
DEVICE: AMICAS VISION SERIES PACS, MODEL 4.3
AMICAS, INC. 510(k) NO: K062477(TRADITIONAL)
ATTN: PATRICE JC NEDELEC PHONE NO : 617-779-7878
20 GUEST ST. SE DECISION MADE: 27-OCT-06
BOSTON, MA 02135 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ANGIODYNAMICS PROFILER PTA BALLOON CATHETER
ANGIODYNAMICS, INC. 510(k) NO: K062609(SPECIAL)
ATTN: TERI JUCKETT PHONE NO : 518-798-1215
603 QUEENSBURY AVE. SE DECISION MADE: 06-OCT-06
QUEENSBURY, NY 12804 510(k) STATEMENT
DEVICE: CONFORM
APEX DENTAL MATERIALS, INC. 510(k) NO: K062157(TRADITIONAL)
ATTN: CHRIS KULTON PHONE NO : 877-273-9123
23329 MALLARD COURT SE DECISION MADE: 13-OCT-06
DEER PARK, IL 60010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155,
APPLE MEDICAL CORP. 510(k) NO: K061651(TRADITIONAL)
ATTN: JOHN C PULFORD PHONE NO : 508-357-2700
28 LORD RD., UNIT 135 SE DECISION MADE: 20-OCT-06
MARLBORO, MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCUSTEP DOA SINGLE AND MULTI-STRIP SCREEN PANELS
APPLIED DNA TECHNOLOGIES, INC. 510(k) NO: K061005(TRADITIONAL)
ATTN: FENG-YU LEE PHONE NO : 714-624-2347
26251 VERONA PLACE SE DECISION MADE: 04-OCT-06
MISSION VIEJO, CA 92692 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SILVERLON CA (CALCIUM ALGINATE)
ARGENTUM MEDICAL, LLC. 510(k) NO: K053590(TRADITIONAL)
ATTN: WILLIAM A CLEMNTI PHONE NO : 484-530-5110
8 TOWER BRIDGE SE DECISION MADE: 06-OCT-06
161 WASHINGTON STREET 510(k) SUMMARY AVAILABLE FROM FDA
CONSHOHOCKEN, PA 19428
DEVICE: ARTHREX CORKSCREW SUTURE ANCHOR, TAK, AND PUSHLOCK FAMILY
ARTHREX, INC. 510(k) NO: K061863(TRADITIONAL)
ATTN: ANN WATERHOUSE PHONE NO : 239-643-5553
1370 CREEKSIDE BLVD. SE DECISION MADE: 19-OCT-06
NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINI TIGHTROPE REPAIR KIT, MODEL AR-8911DS
ARTHREX, INC. 510(k) NO: K061925(TRADITIONAL)
ATTN: SALLY FOUST PHONE NO : 239-643-5553
1370 CREEKSIDE BLVD. SE DECISION MADE: 31-OCT-06
NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPUS SMARTSTICH SUTURE DEVICE WITH PERFECTPASSER CONNECTOR
ARTHROCARE CORP. 510(k) NO: K062244(SPECIAL)
ATTN: LAURA KASPEROWICZ PHONE NO : 949-276-4306
27130 A PASEO ESPADA SE DECISION MADE: 02-OCT-06
SUITE 1427 510(k) SUMMARY AVAILABLE FROM FDA
SAN JUAN CAPISTRANO, CA 92675
DEVICE: TREASURE
ASAHI INTECC CO., LTD. 510(k) NO: K061984(TRADITIONAL)
ATTN: YOSHI TERAI PHONE NO : 949-756-8252
1301 DOVE STREET, SUITE #350 SE DECISION MADE: 05-OCT-06
NEWPORT BEACH, CA 92660 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASCENSION HUMERAL RESURFACING ARTHROPLASTY SYSTEM
ASCENSION ORTHOPEDICS, INC. 510(k) NO: K062861(TRADITIONAL)
ATTN: GLEN NEALLY PHONE NO : 512-836-5001
8700 CAMERON RD., STE. 100 SE DECISION MADE: 31-OCT-06
AUSTIN, TX 78754-3832 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VANGUARD REPROCESSED SUTURE PASSER
ASCENT HEALTHCARE SOLUTIONS 510(k) NO: K053585(TRADITIONAL)
ATTN: MOIRA BARTON PHONE NO : 480-763-5350
10232 SOUTH 51ST ST. SE DECISION MADE: 11-OCT-06
PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NET-2000 MICROCURRENT STIMULATOR
AURI-STIM MEDICAL, INC. 510(k) NO: K060158(TRADITIONAL)
ATTN: LEWIS WARD PHONE NO : 303-530-3279
4655 KIRKWOOD COURT SE DECISION MADE: 13-OCT-06
BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM
B. BRAUN MEDICAL, INC. 510(k) NO: K062700(TRADITIONAL)
ATTN: SCOTT PEASE PHONE NO : 610-596-2376
901 MARCON BLVD. SE DECISION MADE: 26-OCT-06
ALLENTOWN, PA 18109-9341 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM
B. BRAUN MELSUNGEN AG 510(k) NO: K062699(TRADITIONAL)
ATTN: SCOTT PEASE PHONE NO : 610-596-2376
901 MARCON BLVD SE DECISION MADE: 26-OCT-06
ALLENTOWN, PA 18109-9341 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODIFICATION TO G2 FILTER SYSTEM-FEMORAL DELIVERY KIT, MODEL RF-
BARD PERIPHERAL VASCULAR 510(k) NO: K062887(SPECIAL)
ATTN: GENEVIEVE BALUTOWSKI PHONE NO : 480-303-2524
1625 WEST 3RD ST. SE DECISION MADE: 26-OCT-06
PO BOX 1740 510(k) SUMMARY AVAILABLE FROM FDA
TEMPE, AZ 85280-1740
DEVICE: XENIUM DIALYZER, MODELS 110, 130, 150, 170, 190 AND 210
BAXTER HEALTHCARE CORPORATION 510(k) NO: K062079(TRADITIONAL)
ATTN: DAVID E CURTIN PHONE NO : 847-785-6079
1620 WAUKEGAN ROAD SE DECISION MADE: 19-OCT-06
MPGR-AL 510(k) SUMMARY AVAILABLE FROM FDA
MCGAW PARK, IL 60085
DEVICE: BEAVERITE BODY FAT SCALES, MODELS 8901, 8903, 8905, 8909, 8911,
BEAVERITE INTERNATIONAL LIMITED 510(k) NO: K060538(TRADITIONAL)
ATTN: PATSY J TRISLER PHONE NO : 301-652-5344
5600 WISCONSIN AVE. SE DECISION MADE: 10-OCT-06
SUITE 509 510(k) SUMMARY AVAILABLE FROM FDA
CHEVY CHASE, MD 20815
DEVICE: ACCESS EPO ASSAY
BECKMAN COULTER, INC. 510(k) NO: K052223(ABBREVIATED)
ATTN: LYNN WEIST PHONE NO : 952-368-1271
1000 LAKE HAZELTINE DR. SE DECISION MADE: 06-OCT-06
CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COULTER LH 780 HEMATOLOGY ANALYZER
BECKMAN COULTER, INC. 510(k) NO: K061616(ABBREVIATED)
ATTN: NANCY NADLER PHONE NO : 305-380-4191
11800 SW 147TH AVE. SE DECISION MADE: 04-OCT-06
MIAMI, FL 33196-2500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT)
BECKMAN COULTER, INC. 510(k) NO: K062516(SPECIAL)
ATTN: TYLER FOUTCH PHONE NO : 952-368-1653
1000 LAKE HAZELTINE DR. SE DECISION MADE: 05-OCT-06
CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TICARCILLIN (GN) 1-12
BECTON, DICKINSON & CO. 510(k) NO: K062680(TRADITIONAL)
ATTN: VICKI L KENNEDY PHONE NO : 410-316-4161
7 LOVETON CIR. SE DECISION MADE: 05-OCT-06
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEN - TICARCILLIN-CLAVULANA
BECTON, DICKINSON & CO. 510(k) NO: K062687(TRADITIONAL)
ATTN: JANINE MATLAK PHONE NO : 410-316-4938
7 LOVETON CIR. SE DECISION MADE: 24-OCT-06
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BELMONT BUDDY PLUS FLUID WARMER
BELMONT INSTRUMENT CORP. 510(k) NO: K062774(SPECIAL)
ATTN: URAIWAN P LABADINI PHONE NO : 978-663-0212
780 BOSTON RD. SE DECISION MADE: 19-OCT-06
BILLERICA, MA 01821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOMS
BIOGREEN MEDICAL SDN. BHD. 510(k) NO: K062730(ABBREVIATED)
ATTN: SRI MAHENDRA SATHIACAMA PHONE NO : 601 2 5065511
OFF 3/4 MILE JALAN BERCHAM SE DECISION MADE: 05-OCT-06
KAWASAN PERINDUSTRIAN BERCHAM 510(k) STATEMENT
IPOH, PERAK, MALAYSIA 31400
DEVICE: BIOLUCENT APPLICATOR KIT
BIOLUCENT, INC. 510(k) NO: K062830(SPECIAL)
ATTN: DAVE CAMPBELL PHONE NO : 949-349-1380
6 JOURNEY, SUITE 325 SE DECISION MADE: 20-OCT-06
ALISO VIEJO, CA 92656 510(k) STATEMENT
DEVICE: REPICCI II METAL BACK INLAY UNICOMPARTMENTAL TIBIAL BEARING COMP
BIOMET MANUFACTURING CORP. 510(k) NO: K061681(TRADITIONAL)
ATTN: LESTER F PADILLA PHONE NO : 574-372-1644
PO BOX 587 SE DECISION MADE: 19-OCT-06
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M2A-MAGNUM TRI-SPIKE ACETABULAR COMPONENT
BIOMET MANUFACTURING CORP. 510(k) NO: K062995(SPECIAL)
ATTN: PATRICIA S BERES PHONE NO : 574-267-6639
PO BOX 587 SE DECISION MADE: 31-OCT-06
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALTRA PRESS-FIT HIP SYSTEM
BIOMET MANUFACTURING CORP. 510(k) NO: K063002(SPECIAL)
ATTN: GARY BAKER PHONE NO : 574-267-6639
56 EAST BELL DRIVE SE DECISION MADE: 31-OCT-06
WARSAW, IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3DNET SUITE
BIOTRONICS3D, LTD. 510(k) NO: K063107(TRADITIONAL)
ATTN: HARALAMBOS HATZAKIS PHONE NO :
31 FERRY ST., DOCKLANDS SE DECISION MADE: 27-OCT-06
LONDON, UNITED KINGDOM E14 3DT 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MEDLOG, MODEL 1-0-10
BMC GESELLSCHAFT FUR MEDIZINTECHNI510(k) NO: K060756(TRADITIONAL)
ATTN: ANGELIKA M BERGER PHONE NO : 494 076 6292712
MARTINISTRASSE 52 SE DECISION MADE: 30-OCT-06
PAVILLON 41A (UKE) 510(k) SUMMARY AVAILABLE FROM FDA
HAMBURG, GERMANY D-20251
DEVICE: SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM
BOSTON SCIENTIFIC 510(k) NO: K062387(SPECIAL)
ATTN: ANGIE BYLAND PHONE NO : 763-494-2887
ONE SCIMED PLACE SE DECISION MADE: 05-OCT-06
MAPLE GROVE, MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OCCLUSION BALLOON
BOSTON SCIENTIFIC CORP. 510(k) NO: K062202(SPECIAL)
ATTN: CHRISTINE M CAMERON PHONE NO : 508-683-4471
100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 20-OCT-06
MARLBOROUGH, MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VACORA 14G BIOPSY PROBES, MODELS VB14116, VB14138
C.R. BARD, INC. 510(k) NO: K062832(SPECIAL)
ATTN: GLENN NORTON PHONE NO : 480-894-9515
P.O. BOX 1740 SE DECISION MADE: 20-OCT-06
1625 W. 3RD STREET 510(k) SUMMARY AVAILABLE FROM FDA
TEMPE, AZ 85280-1740
DEVICE: PMP4 APPLICATION
CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K061428(TRADITIONAL)
ATTN: ALEX GONOROVSKY PHONE NO : 972 8 9484000
2 PEKERIS ST., SCIENCE PARK SE DECISION MADE: 16-OCT-06
P.O.B. 527 510(k) STATEMENT
REHOVOT, ISRAEL 76100
DEVICE: CARDIOMEMS ENDOSURE PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL
CARDIOMEMS, INC. 510(k) NO: K061046(TRADITIONAL)
ATTN: CAROL VIERLING PHONE NO : 404-920-6712
75 FIFTH ST., NW SE DECISION MADE: 12-OCT-06
SUITE 440 510(k) SUMMARY AVAILABLE FROM FDA
ATLANTA, GA 30308
DEVICE: LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT
CATCH INCORPORATED 510(k) NO: K062808(SPECIAL)
ATTN: CINDY GREEN PHONE NO : 425-765-9509
21031 SE 202ND STREET SE DECISION MADE: 13-OCT-06
RENTON, WA 98058 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CENTARISONE RIS/PACS
CENTARISONE, LLC 510(k) NO: K063037(TRADITIONAL)
ATTN: SCOTT SHANNON PHONE NO : 888-747-2002
11925 WILSHIRE BLVD. SE DECISION MADE: 18-OCT-06
SUITE 301 510(k) SUMMARY AVAILABLE FROM FDA
LOS ANGELES, CA 90025 THIRD PARTY REVIEW
DEVICE: CERAGEM RH1 AUTOMATIC THERMAL MASSAGER
CERAGEM INTERNATIONAL, INC. 510(k) NO: K062476(TRADITIONAL)
ATTN: SUSAN ONEL PHONE NO : 202-778-9134
1601 K STREET NW SE DECISION MADE: 31-OCT-06
WASHINGTON, DC 20006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CERES PTA CATHETER MODELS PTA018,PTA035 VARIOUS SIZES
CERES MEDICAL SYSTEMS, L.L.C. 510(k) NO: K060927(TRADITIONAL)
ATTN: CORRINE BONFIGLIO PHONE NO : 858-342-0344
13195 SEAGROVE ST SE DECISION MADE: 06-OCT-06
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAREVENT
CHIEF MEDICAL LLC 510(k) NO: K062240(TRADITIONAL)
ATTN: SCOTT HORN PHONE NO : 307-690-1920
PO BOX 772 SE DECISION MADE: 16-OCT-06
105 PIONEER LANE 510(k) SUMMARY AVAILABLE FROM FDA
TETON VILLAGE, WY 83025
DEVICE: RAPID DIGITAL THERMOMETER, MODEL RDT -18 SERIES
CHOICE SMART HEALTH CARE COMPANY L510(k) NO: K062016(TRADITIONAL)
ATTN: JANICE MA PHONE NO : 862 163 345066
2108 CIRO'S PLAZA SE DECISION MADE: 27-OCT-06
388 WEST NANJING ROAD 510(k) SUMMARY AVAILABLE FROM FDA
SHANGHAI, CHINA 200003 THIRD PARTY REVIEW
DEVICE: CHRONOS VISION EYE TRACKING DEVICE (C-ETD)
CHRONOS VISION 510(k) NO: K062015(TRADITIONAL)
ATTN: MAUREEN O'CONNELL PHONE NO : 978-207-1245
5 TIMBER LANE SE DECISION MADE: 31-OCT-06
NORTH READING, MA 01864 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLINIQA LIQUID QC CARDIAC MARKER CONTROL SP, LEVELS 1,2, &3
CLINIQA CORPORATION 510(k) NO: K062916(TRADITIONAL)
ATTN: CAROL RUGGIERO PHONE NO : 760-744-1900
1432 SOUTH MISSION RD. SE DECISION MADE: 23-OCT-06
FALLBROOK, CA 92028 510(k) STATEMENT
DEVICE: CODMAN VPV SYSTEM, MODEL 82-3192
CODMAN & SHURTLEFF, INC. 510(k) NO: K061876(TRADITIONAL)
ATTN: SUSAN KAGAN PHONE NO : 508-880-8097
325 PARAMOUNT DRIVE SE DECISION MADE: 16-OCT-06
RAYNHAM, MA 02767-3050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLLAGEN DENTAL MEMBRANE III
COLLAGEN MATRIX, INC. 510(k) NO: K062846(SPECIAL)
ATTN: PEGGY HANSON PHONE NO : 201-405-1477
509 COMMERCE ST. SE DECISION MADE: 13-OCT-06
FRANKLIN LAKES,, NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLLAGEN DENTAL MENBRANE - CONFORMABLE II
COLLAGEN MATRIX, INC. 510(k) NO: K062881(SPECIAL)
ATTN: PEGGY HANSEN PHONE NO : 201-405-1477
509 COMMERCE ST. SE DECISION MADE: 11-OCT-06
FRANKLIN LAKES,, NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLOPLAST OSTOMY ROD, MODEL 12814
COLOPLAST CORP. 510(k) NO: K052229(TRADITIONAL)
ATTN: ELIZABETH BOOTS PHONE NO : 507-345-0200
1940 COMMERCE DR. SE DECISION MADE: 13-OCT-06
NORTH MANKATO, MN 56003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMFORT SCOOTER, MODEL LY-EW415
COMFORT ORTHOPEDIC CO. LTD. 510(k) NO: K063032(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829
NO.58,FU-CHIUN ST. SE DECISION MADE: 16-OCT-06
HSIN-CHU CITY, CHINA (TAIWAN) 3006510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONFIDANT 2.0
CONFIDANT INC. 510(k) NO: K062215(SPECIAL)
ATTN: DANIEL R PLONSKI PHONE NO : 919-806-4323
2530 MERIDIAN PARKWAY SE DECISION MADE: 16-OCT-06
SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA
DURHAM, NC 27713
DEVICE: CONMED LINVATEC INSTRUMENT STERILIZATION TRAY
CONMED LINVATEC 510(k) NO: K052992(TRADITIONAL)
ATTN: ELIZABETH PAUL PHONE NO : 727-399-5234
11311 CONCEPT BOULEVARD SE DECISION MADE: 16-OCT-06
LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGISIS PEYRONIE'S REPAIR GRAFT, MODEL SPR-100
COOK BIOTECH, INC. 510(k) NO: K062320(TRADITIONAL)
ATTN: MARY A FADERAN PHONE NO : 765-497-3355
1425 INNOVATION PLACE SE DECISION MADE: 02-OCT-06
WEST LAFAYETTE, IN 47906 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGISIS, SURGISIS ES
COOK BIOTECH, INC. 510(k) NO: K062696(SPECIAL)
ATTN: MARY A FADERAN PHONE NO : 765-497-3355
1425 INNOVATION PLACE SE DECISION MADE: 13-OCT-06
WEST LAFAYETTE, IN 47906 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIS HERNIA REPAIR DEVICE, SURGISIS GOLD HERNIA REPAIR GRAFT
COOK BIOTECH, INC. 510(k) NO: K062697(SPECIAL)
ATTN: MARY A FADERAN PHONE NO : 765-497-3355
1425 INNOVATION PLACE SE DECISION MADE: 13-OCT-06
WEST LAFAYETTE, IN 47906 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGISIS RVP RECTO-VAGINAL FISTULA PLUG
COOK BIOTECH, INC. 510(k) NO: K062729(SPECIAL)
ATTN: DANIEL J DILLON PHONE NO : 765-463-7537
1400 CUMBERLAND AVE. SE DECISION MADE: 10-OCT-06
WEST LAFAYETTE, IN 47906 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500
COOK OB/GYN 510(k) NO: K062438(TRADITIONAL)
ATTN: CINDY RUMPLE PHONE NO : 812-829-4891
1100 WEST MORGAN STREET SE DECISION MADE: 27-OCT-06
SPENCER, IN 47460 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO PHYTACARE ALGINATE HYDROGEL WOUND FILLER
CURAPHARM, INC. 510(k) NO: K053538(TRADITIONAL)
ATTN: THOMAS M HNAT PHONE NO : 619-449-7388
10054 PROSPECT AVENUE, SUITE F SE DECISION MADE: 10-OCT-06
SANTEE, CA 92071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTLIPO ND:YAG LASER
CYNOSURE, INC. 510(k) NO: K062321(TRADITIONAL)
ATTN: GEORGE CHO PHONE NO : 978-256-4200
5 CARLISLE ROAD SE DECISION MADE: 31-OCT-06
WESTFORD, MA 01886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA RF FLEX REAGENT CARTRIDGE; PROTEIN 2 CALIBRATOR
DADE BEHRING, INC. 510(k) NO: K062035(TRADITIONAL)
ATTN: KATHLEEN DRAY-LYONS PHONE NO : 781-826-4551
P.O. BOX 6101 SE DECISION MADE: 04-OCT-06
NEWARK,, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN MICROSTREP PLUS PANEL ERYTHROMYCIN (0.015 TO 2 MCG/ML)
DADE BEHRING, INC. 510(k) NO: K062375(TRADITIONAL)
ATTN: MAUREEN MENDE PHONE NO : 916-374-3174
2040 ENTERPRISE BLVD. SE DECISION MADE: 26-OCT-06
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH LINEZOLID
DADE BEHRING, INC. 510(k) NO: K062705(TRADITIONAL)
ATTN: ROBERT EUSEBIO PHONE NO : 916-374-3183
2040 ENTERPRISE BLVD. SE DECISION MADE: 20-OCT-06
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN MICROSTREP PLUS PANEL, PENICILLIN
DADE BEHRING, INC. 510(k) NO: K062773(TRADITIONAL)
ATTN: LIBBY WARRINER PHONE NO : 916-374-3244
1584 ENTERPRISE BLVD. SE DECISION MADE: 13-OCT-06
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN MICROSTREP PLUS PANEL, CLINDAMYCIN
DADE BEHRING, INC. 510(k) NO: K062777(TRADITIONAL)
ATTN: MAUREEN MENDE PHONE NO : 916-374-3174
1584 ENTERPRISE BLVD. SE DECISION MADE: 10-OCT-06
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN MICROSTREP PLUS PANEL TETRACYCLINE (0.006 TO 16 MCG/ML
DADE BEHRING, INC. 510(k) NO: K062923(TRADITIONAL)
ATTN: LIBBY WARRINER PHONE NO : 916-374-3244
2040 ENTERPRISE BLVD. SE DECISION MADE: 13-OCT-06
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN MICROSTREP PLUS PANEL AMPICILLIN (0.013 - 16 MCG/ML)
DADE BEHRING, INC. 510(k) NO: K062927(TRADITIONAL)
ATTN: MAY MORISHIMA PHONE NO : 916-374-2006
2040 ENTERPRISE BLVD. SE DECISION MADE: 12-OCT-06
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN MICROSTREP PLUS PANEL CEFUROXIME (0.12-8 MCG/ML)
DADE BEHRING, INC. 510(k) NO: K063053(TRADITIONAL)
ATTN: SHANNON POPSON PHONE NO : 916-374-3330
2040 ENTERPRISE BLVD. SE DECISION MADE: 26-OCT-06
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN MICROSTREP PLUS PANEL CEFTRIAXONE (0.015-8MCG/ML)
DADE BEHRING, INC. 510(k) NO: K063064(TRADITIONAL)
ATTN: MAUREEN MENDE PHONE NO : 916-374-3174
2040 ENTERPRISE BLVD. SE DECISION MADE: 26-OCT-06
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN MICROSTREP PLUS PANEL MEROPENEM (0.03-4MCG/ML)
DADE BEHRING, INC. 510(k) NO: K063065(TRADITIONAL)
ATTN: MAUREEN MENDE PHONE NO : 916-374-3174
2040 ENTERPRISE BLVD. SE DECISION MADE: 27-OCT-06
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DARCO FORCE TITANIUM COMPRESSION SCREW
DARCO INTERNATIONAL, INC. 510(k) NO: K062103(TRADITIONAL)
ATTN: MARK S COOPER PHONE NO : 304-522-4883
810 MEMORIAL BLVD. SE DECISION MADE: 25-OCT-06
HUNTINGTON, WV 25701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARD COMPOSITE L/P MESH
DAVOL INC., SUB. C.R. BARD, INC. 510(k) NO: K061754(TRADITIONAL)
ATTN: GAIL DOW PHONE NO : 401-215-2642
100 SOCKANOSSETT CROSSROAD SE DECISION MADE: 23-OCT-06
CRANSTON, RI 02920 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOMAS PIN 6 MM
DENTAURUM 510(k) NO: K062732(TRADITIONAL)
ATTN: CHARLES R BELL PHONE NO : 267-756-6517
10 PHEASANT RUN SE DECISION MADE: 25-OCT-06
NEWTOWN, PA 18940 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISTADENT OC - VERSION 4
DENTSPLY INTL., INC. 510(k) NO: K060836(SPECIAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511
SUSQUEHANNA COMMERCE CENTER SE DECISION MADE: 27-OCT-06
221W PHILADELPHIA ST. SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17404
DEVICE: DEPUY PINNACLE ALTRX ACETABULAR CUP LINER
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K062148(TRADITIONAL)
ATTN: ANNE M SCHULER PHONE NO : 574-372-7098
700 ORTHOPAEDIC DR. SE DECISION MADE: 24-OCT-06
P.O BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: DEPUY LPS PROXIMAL TIBIAL COMPONENT
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K062301(SPECIAL)
ATTN: NANCY FRIDDLE PHONE NO : 574-371-4923
700 ORTHOPAEDIC DR. SE DECISION MADE: 13-OCT-06
P.O BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: FRS SCREW
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K062352(TRADITIONAL)
ATTN: REBECCA LENNARD PHONE NO : 574-372-5023
700 ORTHOPAEDIC DRIVE SE DECISION MADE: 19-OCT-06
WARSAW, IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEALOS FX BONE GRAFT SUBSTITUTE AND GRAFT MIXING AND DELIVERY SY
DEPUY SPINE, INC. 510(k) NO: K062495(TRADITIONAL)
ATTN: MELANIE ARCHER PHONE NO : 508-828-3537
325 PARAMOUNT DR. SE DECISION MADE: 13-OCT-06
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THERMACLEAR
DERMACARE, INC. 510(k) NO: K060653(TRADITIONAL)
ATTN: HEIDI STARK PHONE NO : 925-371-3900
6248 PRESTON AVENUE SE DECISION MADE: 24-OCT-06
LIVERMORE, CA 94551 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DMS 300-2, 300-3 AND 300-4
DIAGNOSTIC MONITORING SOFTWARE 510(k) NO: K062959(SPECIAL)
ATTN: WILLIAM PARSONS PHONE NO : 714-953-2653
292 KINGSBURY GRADE, #32 SE DECISION MADE: 16-OCT-06
P.O. BOX 3109 510(k) SUMMARY AVAILABLE FROM FDA
STATELINE, NV 89449
DEVICE: LIAISON EA IGG
DIASORIN, INC. 510(k) NO: K060204(TRADITIONAL)
ATTN: DAVID M IKEDA PHONE NO : 651-351-5592
1951 NORTHWESTERN AVE. SE DECISION MADE: 18-OCT-06
P.O. BOX 285 510(k) SUMMARY AVAILABLE FROM FDA
STILLWATER, MN 55082 THIRD PARTY REVIEW
DEVICE: ACCUSOFT, ACCUSOFT XL
DIREX SYSTEMS CORP. 510(k) NO: K062032(TRADITIONAL)
ATTN: LARISA GERSHTEIN PHONE NO : 888-874-7837
437 TURNPIKE ST. SE DECISION MADE: 05-OCT-06
CANTON, MA 02021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTEGRA SL
DIREX SYSTEMS CORP. 510(k) NO: K062147(SPECIAL)
ATTN: LARISA GERSHTEIN PHONE NO : 339-502-6013
437 TURNPIKE ST. SE DECISION MADE: 20-OCT-06
CANTON, MA 02021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OXYLOG 3000
DRAGER MEDICAL B.V. 510(k) NO: K062267(TRADITIONAL)
ATTN: BRYAN OVERTON PHONE NO : 215-721-5400
3135 QUARRY ROAD SE DECISION MADE: 31-OCT-06
TELFORD, PA 18969 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII
DUTCH OPHTHALMIC RESEARCH CENTER I510(k) NO: K062895(SPECIAL)
ATTN: F CARLETON PHONE NO : 603-642-8468
ONE LITTLE RIVER RD. SE DECISION MADE: 13-OCT-06
KINGSTON, NH 03848 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTRODE COATED BALL, MODEL AB302C; NEEDLE, MODEL AN301C; BLADE
E SURGICAL, LLC 510(k) NO: K061878(TRADITIONAL)
ATTN: LEWIS WARD PHONE NO : 303-530-3279
4655 KIRKWOOD COURT SE DECISION MADE: 24-OCT-06
BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SANDMAN POCKET
EB NEURO, S.P.A. 510(k) NO: K061996(TRADITIONAL)
ATTN: CARRI GRAHAM PHONE NO : 317-569-9500
11460 N. MERIDIAN ST. SE DECISION MADE: 03-OCT-06
SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA
CARMEL, IN 46032 THIRD PARTY REVIEW
DEVICE: EBI OPTILOCK UPPER EXTREMITY PLATING SYSTEM
EBI, L.P. 510(k) NO: K062494(TRADITIONAL)
ATTN: DEBRA BING PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 19-OCT-06
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBI ARAY SPINAL SYSTEM
EBI, L.P. 510(k) NO: K062685(SPECIAL)
ATTN: DEBRA BING PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 06-OCT-06
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLITAIRE ANTERIOR SPINAL SYSTEM
EBI, L.P. 510(k) NO: K062810(SPECIAL)
ATTN: DEBRA BING PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 17-OCT-06
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECO-RX AIR PURIFIER WITH UV LIGHT, MODEL RX-400
ECO-RX, INC. 510(k) NO: K062716(TRADITIONAL)
ATTN: CONSTANCE R BROWN, ESQ. PHONE NO : 418 692 0735
34 AVENUE ST. DENIS SE DECISION MADE: 27-OCT-06
QUEBEC CITY, QC, CANADA G1R-4B6 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: 5 MEGAPIXEL MONOCHROME LCD MONITOR, RADIFORCE GS510
EIZO NANAO CORPORATION 510(k) NO: K062054(SPECIAL)
ATTN: HIROAKI HASHIMOTO PHONE NO : 817 627 42468
153 SHIMOKASHIWANO-CHO SE DECISION MADE: 06-OCT-06
MATTO-SHI 510(k) SUMMARY AVAILABLE FROM FDA
ISHIKAWA-KEN, JAPAN 924-8566
DEVICE: MEDICAL COMPRESSOR, MODELS DK50 D AND DM
EKOM S.R.O. 510(k) NO: K060781(TRADITIONAL)
ATTN: ESTHER SALTZ PHONE NO : 949-463-8083
32884 DANAPOPLAR SE DECISION MADE: 03-OCT-06
DANA POINT, CA 92629 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNISIGHT MAMMOGRAPHY VIEWER, MODEL 4.0
ELECTRONIC BUSINESS MACHINE CO., L510(k) NO: K062743(TRADITIONAL)
ATTN: JEFFREY CHERN PHONE NO : 808-945-3100
1600 KAPIOLANI BLVD. SE DECISION MADE: 31-OCT-06
SUITE 1300 510(k) STATEMENT
HONOLULU, HI 96814
DEVICE: MIDDLE WHEEL DRIVE POWER CHAIR, CWD01
EMG TECHNOLOGY CO., LTD. 510(k) NO: K062888(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829
NO. 58, FU-CHINU ST. SE DECISION MADE: 24-OCT-06
HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EP-WORKMATE
EP MEDSYSTEMS 510(k) NO: K063113(SPECIAL)
ATTN: LARRY PICCIANO PHONE NO : 856-753-8533
COOPER RUN EXECUTIVE PARK SE DECISION MADE: 27-OCT-06
575 ROUTE 73 N. BLDG. D 510(k) SUMMARY AVAILABLE FROM FDA
WEST BERLIN, NJ 08091
DEVICE: IMT.LAB SOFTWARE
ESAOTE EUROPE B.V. 510(k) NO: K062598(TRADITIONAL)
ATTN: CARRI GRAHAM PHONE NO : 317-569-9500
11460 N. MERIDIAN STREET SE DECISION MADE: 31-OCT-06
SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA
CARMEL, IN 46032
DEVICE: TERRAQUANT MQ2000 V. 5 AND HANDYRX MQ2007 LASERS
ESCADA INTERNATIONAL, INC. 510(k) NO: K061614(SPECIAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 06-OCT-06
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BASX BLADELESS TROCAR
ETHICON ENDO-SURGERY, LLC 510(k) NO: K062209(TRADITIONAL)
ATTN: DENNIS HAHN PHONE NO : 513-337-3134
4545 CREEK ROAD SE DECISION MADE: 10-OCT-06
CINCINNATI, OH 45242 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZERION ALPHA, ; ZERION BETA
ETKON INTERNATIONAL GMBH 510(k) NO: K061804(TRADITIONAL)
ATTN: MATTHIAS ZITZMANN PHONE NO : 893 090 75400
LOCHHAMER SCHLAG 6 SE DECISION MADE: 06-OCT-06
GRAFELFING, BAVARIA, GERMANY 82166510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KIT
EUROIMMUN US LLC 510(k) NO: K061408(TRADITIONAL)
ATTN: KATHRYN KOHL PHONE NO : 973-402-6101
429 ROCKAWAY VALLEY RD. SE DECISION MADE: 05-OCT-06
UNIT 1200 510(k) STATEMENT
BOONTON TWP, NJ 07005
DEVICE: XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236,
EXCEL TECH. LTD. 510(k) NO: K062549(TRADITIONAL)
ATTN: NICOLE LANDREVILLE PHONE NO : 905 829 5300
2568 BRISTOL CIRCLE SE DECISION MADE: 04-OCT-06
OAKVILLE, ONTARIO, CANADA L6H 5S1510(k) STATEMENT
DEVICE: SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
FOXHOLLOW TECHNOLOGIES, INC. 510(k) NO: K061188(TRADITIONAL)
ATTN: MELISSA S MURPHY PHONE NO : 650-421-8579
740 BAY ROAD SE DECISION MADE: 23-OCT-06
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRISMA SYSTEM R03.10A
GAMBRO RENAL PRODUCTS 510(k) NO: K062090(TRADITIONAL)
ATTN: THOMAS B DOWELL PHONE NO : 303-231-4094
10810 W. COLLINS AVE. SE DECISION MADE: 18-OCT-06
LAKEWOOD, CO 80215 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM
GEN-PROBE, INC. 510(k) NO: K061413(TRADITIONAL)
ATTN: BRIAN J SHEA PHONE NO : 858-410-8535
10210 GENETIC CENTER DR. SE DECISION MADE: 13-OCT-06
SAN DIEGO, CA 92121-4362 510(k) STATEMENT
DEVICE: TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MOD
GEN-PROBE, INC. 510(k) NO: K061509(TRADITIONAL)
ATTN: BRIAN J SHEA PHONE NO : 858-410-8535
10210 GENETIC CENTER DR. SE DECISION MADE: 04-OCT-06
SAN DIEGO, CA 92121-4362 510(k) STATEMENT
DEVICE: AXIOM PULSED LIGHT SYSTEM
GENERAL PROJECT S.R.L. 510(k) NO: K062312(TRADITIONAL)
ATTN: CORNELIA DAMSKY PHONE NO : 203-323-7535
56 WESTCOTT ROAD SE DECISION MADE: 16-OCT-06
STAMFORD, CT 06902 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENICON DISPOSABLE ELECTROSURGICAL INSTRUMENTATION, MODEL 533-00
GENICON 510(k) NO: K061417(TRADITIONAL)
ATTN: GARY HABERLAND PHONE NO : 407-657-4851
6869 STAPOINT CT., SUITE 114 SE DECISION MADE: 10-OCT-06
WINTER PARK, FL 32792 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
GIVEN IMAGING LTD. 510(k) NO: K062786(SPECIAL)
ATTN: SHOSHANA FRIEDMAN PHONE NO : 011 972 49097784
SHAAR YOKNEAM (HERMON BUILDING SE DECISION MADE: 18-OCT-06
NEW INDUSTRIAL ZONE, 510(k) SUMMARY AVAILABLE FROM FDA
YOKNEAM (P.O.BOX 258), ISRAEL 20692
DEVICE: RAPID DIGITAL THERMOMETER, MODEL RDT -18 SERIES
GLOBAL TREASURE INDUSTRIES LTD. 510(k) NO: K062010(TRADITIONAL)
ATTN: JANICE MA PHONE NO : 862 163 345066
2108 CIRO'S PLAZA SE DECISION MADE: 27-OCT-06
388 WEST NANJING ROAD 510(k) SUMMARY AVAILABLE FROM FDA
SHANGHAI, CHINA 20003 THIRD PARTY REVIEW
DEVICE: GLUCOPLUS BLOOD GLUCOSE MONITORING SYSTEM
GLUCOPLUS INC 510(k) NO: K061234(TRADITIONAL)
ATTN: JEFFREY FLEISHMAN PHONE NO : 215-815-0897
315 PARKVIEW WAY SE DECISION MADE: 30-OCT-06
NEWTOWN, PA 18940 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GRACE MEDICAL PC COATED TYMPANOSTOMY TUBES
GRACE MEDICAL, INC. 510(k) NO: K062672(TRADITIONAL)
ATTN: JEFF COBB PHONE NO : 901-380-7000
8500 WOLF LAKE DR., STE. 110 SE DECISION MADE: 24-OCT-06
MEMPHIS, TN 38133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GYNESONICS EC6 TRANSDUCER
GYNESONICS, INC. 510(k) NO: K061153(TRADITIONAL)
ATTN: JESSICA GROSSMAN, MD PHONE NO : 415-317-3241
604 FIFTH AVE. SE DECISION MADE: 27-OCT-06
SUITE D 510(k) SUMMARY AVAILABLE FROM FDA
REDWOOD CITY, CA 94063 THIRD PARTY REVIEW
DEVICE: SMARTSUCTION SOLO DEVICE
HAEMONETICS CORP. 510(k) NO: K062801(TRADITIONAL)
ATTN: GABRIEL J MURACA PHONE NO : 781-356-9553
400 WOOD ROAD SE DECISION MADE: 04-OCT-06
BRAINTREE, MA 02184-9114 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR
HANSEN MEDICAL, INC. 510(k) NO: K061070(TRADITIONAL)
ATTN: NINA PELED PHONE NO : 650-404-5834
380 NORTH BERNARDO AVE. SE DECISION MADE: 13-OCT-06
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDRELIEF ST SERIES, MODELS RT-50, ST-100, ST 150, ST-200, ST-30
HEALTHONICS, INC. 510(k) NO: K060669(TRADITIONAL)
ATTN: JAMES W KRONBERG PHONE NO : 803-652-2354
903 MAIN ST. SOUTH SE DECISION MADE: 13-OCT-06
NEW ELLENTON, SC 29809 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODE
HEIDELBERG ENGINEERING 510(k) NO: K063191(TRADITIONAL)
ATTN: GERHARD ZINSER PHONE NO : 49 622 164630
TIERGARTENSTRASSE 15 SE DECISION MADE: 31-OCT-06
HEIDELBERG, GERMANY 69121 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ECHELON SHOULDER COIL
HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K062556(ABBREVIATED)
ATTN: DOUG THISTLEWAITE PHONE NO : 330-425-1313
1959 SUMMIT COMMERCE PARK SE DECISION MADE: 05-OCT-06
TWINSBURG, OH 44087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHE
HORIBA ABX 510(k) NO: K062180(TRADITIONAL)
ATTN: TIM LAWTON PHONE NO : 334 671 47320
PARC EUROMEDECINE SE DECISION MADE: 02-OCT-06
RUE DU CADUCEE 510(k) SUMMARY AVAILABLE FROM FDA
MONTPELLIER, HERAULT, FRANCE 34184
DEVICE: OPTICATH CENTRAL VENOUS OXIMETRY CATHETER
HOSPIRA, INC. 510(k) NO: K061585(TRADITIONAL)
ATTN: NICOHL WILDING PHONE NO : 224-212-5270
275 N. FIELD DR., BLDG. H-2 SE DECISION MADE: 05-OCT-06
DEPT. 389 510(k) SUMMARY AVAILABLE FROM FDA
LAKE FOREST, IL 60045
DEVICE: SOLAR REUNION FRACTURE STEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K062113(TRADITIONAL)
ATTN: FRANCISCO HARO PHONE NO : 201-831-5493
325 CORPORATE DRIVE SE DECISION MADE: 03-OCT-06
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROFYLE SYSTEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K062498(TRADITIONAL)
ATTN: VIVIAN KELLY PHONE NO : 201-831-5581
325 CORPORATE DRIVE SE DECISION MADE: 25-OCT-06
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHOXP
IMAGING DYNAMICS COMPANY LTD. 510(k) NO: K062634(SPECIAL)
ATTN: SHIRANTHA SAMARAPPULI PHONE NO : 403 251 9939
151,2340 PEGASUS WAY, NE SE DECISION MADE: 06-OCT-06
CALGARY, ALBERTA, CANADA T2E 8M5 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRE' VAGINAL LUBRICANT
INGFERTLITY, LLC 510(k) NO: K051436(TRADITIONAL)
ATTN: DENNIS CLIFTON PHONE NO : 509-443-0149
17206 S. SPANGLE CREEK ROAD SE DECISION MADE: 13-OCT-06
VALLEYFORD, WA 99036 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO INION OTPS BIODEGRADABLE FIXATION SYSTEM
INION OY 510(k) NO: K062617(SPECIAL)
ATTN: KATI MARTINEN PHONE NO : 358 3 2306600
LAAKARINKATU 2 SE DECISION MADE: 04-OCT-06
TAMPERE, FINLAND 33520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLLAGUARD, MODEL FCIA,FCIB,FCIC,AND FCID
INNOCOLL PHARMACEUTICALS 510(k) NO: K061746(TRADITIONAL)
ATTN: AARON WYSE PHONE NO : 353 090 6486834
IDA BUSINESS AND TECHNOLOGY SE DECISION MADE: 02-OCT-06
PARK, GARRYCASTLE 510(k) SUMMARY AVAILABLE FROM FDA
ATHLONE, CO. WESTMEATH, IRELAND
DEVICE: INNOVACON HCG UKTRA TEST DEVICE
INNOVACON, INC. 510(k) NO: K062361(TRADITIONAL)
ATTN: EDWARD TUNG PHONE NO : 858-535-2030
4106 SORRENTO VALLEY BLVD. SE DECISION MADE: 23-OCT-06
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTA LITE PBC SCREEN IGG/IGA ELISA
INOVA DIAGNOSTICS, INC. 510(k) NO: K061842(TRADITIONAL)
ATTN: GARY L NORMAN PHONE NO : 858-586-9900
9900 OLD GROVE RD. SE DECISION MADE: 18-OCT-06
SAN DIEGO, CA 92131-1638 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASK
INOVEL LLC 510(k) NO: K062665(TRADITIONAL)
ATTN: WILLIAM WAWRZYNIAK PHONE NO : 866-546-6835
10111 W. JEFFERSON BLVD. SE DECISION MADE: 24-OCT-06
CULVER CITY, CA 90232-3509 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: P.0004 IMPLANTS
INSTITUT STRAUMANN AG 510(k) NO: K062129(SPECIAL)
ATTN: ELAINE ALAN PHONE NO : 800-448-8168
60 MINUTEMAN ROAD SE DECISION MADE: 20-OCT-06
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTELWAVE HEART RATE VARIABILITY SYSTEM, VERSION 1.0
INTELWAVE, LLC 510(k) NO: K062068(TRADITIONAL)
ATTN: ALEXANDER RIFTINE PHONE NO : 732-738-8800
1090 KING GEORGES POST ROAD SE DECISION MADE: 27-OCT-06
SUITE 1004 510(k) SUMMARY AVAILABLE FROM FDA
EDISON, NJ 08837
DEVICE: ADMIRAL XTREME PTA CATHETER
INVATEC INNOVATIVE TECHNOLOGIES 510(k) NO: K062809(SPECIAL)
ATTN: DAVID WORRELL PHONE NO : 763-398-7344
9600 54TH AVENUE NORTH SE DECISION MADE: 18-OCT-06
PLYMOUTH, MN 55442 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TUTU 7, MODEL IV-T22
INVISIBLE TECHNOLOGY CO., LTD. 510(k) NO: K062735(TRADITIONAL)
ATTN: ALLISON SCOTT PHONE NO : 317-569-9500
11460 N. MERIDIAN ST. SE DECISION MADE: 27-OCT-06
SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA
CARMEL, IN 46032
DEVICE: ESCORT M8 VITAL SIGNS PATIENT MONITOR, MODEL 3810
INVIVO CORPORATION 510(k) NO: K062144(TRADITIONAL)
ATTN: RUSTY KELLY PHONE NO : 800-331-3220
12601 RESEARCH PKWY. SE DECISION MADE: 12-OCT-06
ORLANDO, FL 32826 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CTL-63 AND CTL-128 SPINE ARRAY COILS
INVIVO CORPORATION 510(k) NO: K062767(SPECIAL)
ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402
N27 W23676 PAUL RD. SE DECISION MADE: 13-OCT-06
PEWAUKEE, WI 53072 510(k) STATEMENT
DEVICE: AMNIOSTAT-FLM-PG
IRVINE SCIENTIFIC SALES CO., INC. 510(k) NO: K061549(TRADITIONAL)
ATTN: WENDELL LEE, PHARM. D PHONE NO : 800-437-5706
2511 DAIMLER ST. SE DECISION MADE: 18-OCT-06
SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WALLACE ARTIFICIAL INSEMINATION CATHETER
IRVINE SCIENTIFIC SALES CO., INC. 510(k) NO: K061679(TRADITIONAL)
ATTN: WENDELL LEE PHONE NO : 949-261-7800
2511 DAIMLER ST. SE DECISION MADE: 13-OCT-06
SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERED VINYL PATIENT EXAMINATION GLOVES
JIANGSU JAYSUN GLOVE CO., LTD. 510(k) NO: K062520(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 86 10 82387441
RM 1606 BLDG 1, JIANXIANG YUAN SE DECISION MADE: 11-OCT-06
NO.209 BEI SI HUAN ZHONG RD. 510(k) SUMMARY AVAILABLE FROM FDA
BEIJING, CHINA 100083
DEVICE: KARMA MANUAL WHEELCHAIR, MODELS S-ERGO 305 AND S-ERGO 105
KARMA MEDICAL PRODUCTS CO., LTD. 510(k) NO: K062309(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 10-OCT-06
HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KARMA MANUAL WHEELCHAIR, MODEL BUDGET 800
KARMA MEDICAL PRODUCTS CO., LTD. 510(k) NO: K062311(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 04-OCT-06
HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V.A.C. THERAPY SYSTEM
KCI USA, INC. (KINETIC CONCEPTS, I510(k) NO: K062227(TRADITIONAL)
ATTN: MARGARET MARSH PHONE NO : 210-255-6481
8023 VANTAGE DRIVE SE DECISION MADE: 04-OCT-06
SAN ANTONIO, TX 78230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03
KENSEY NASH CORP. 510(k) NO: K062870(SPECIAL)
ATTN: ROBIN M FATZINGER PHONE NO : 484-713-2100
735 PENNSYLVANIA DRIVE SE DECISION MADE: 20-OCT-06
EXTON, PA 19341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEXUS 3
KERR CORPORATION 510(k) NO: K062519(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 949-255-8766
100 BAYVIEW CIRCLE STE 6000 SE DECISION MADE: 19-OCT-06
NEWPORT BEACH, CA 92660 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CATALYSY
KI MOBILITY LLC 510(k) NO: K062660(TRADITIONAL)
ATTN: DOUGLAS MUNSEY PHONE NO : 715-343-1280
4925 COYE DRIVE SUITE D SE DECISION MADE: 24-OCT-06
STEVENS POINT, WI 54481 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: KMI CEMENT RESTRICTOR IMPLANT
KINETIKOS MEDICAL, INC. 510(k) NO: K061465(TRADITIONAL)
ATTN: JOHN G SPAMPINATO PHONE NO : 760-448-1706
6005 HIDDEN VALLEY RD, STE 180 SE DECISION MADE: 05-OCT-06
CARLSBAD, CA 92011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PATIENT CONTOURED MESH (PCM)
KLS-MARTIN L.P. 510(k) NO: K062570(TRADITIONAL)
ATTN: JENNIFER DAMATO PHONE NO : 904-641-7746
11239 ST. JOHNS INDUSTRIAL SE DECISION MADE: 31-OCT-06
PARKWAY SOUTH 510(k) SUMMARY AVAILABLE FROM FDA
JACKSONVILLE, FL 32246
DEVICE: KOLSTER METHODS, INC., FEATHERLIFT SILHOUETTE SUTURE
KMI KOLSTER METHODS, INC. 510(k) NO: K060414(TRADITIONAL)
ATTN: JEFFREY A KOLSTER PHONE NO : 951-737-5476
3185 PALISADES DR. SE DECISION MADE: 23-OCT-06
CORONA, CA 92882 510(k) STATEMENT
DEVICE: MANZI MACH 1 INSTRUMENT CLEANER-PROCESSOR SYSTEM, MANZI DETERGEN
LANGFORD IC SYSTEMS, INC. 510(k) NO: K060458(TRADITIONAL)
ATTN: JIMMIE T JOHNSTON PHONE NO : 508-850-3154
141 WASHINGTON STREET SE DECISION MADE: 12-OCT-06
EAST WALPOLE, MA 02032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO LIFE SPINE NEO ANTERIOR CERVICAL PLATE SYSTEM
LIFE SPINE 510(k) NO: K062831(SPECIAL)
ATTN: ERIN MALLOY PHONE NO : 847-884-6117
2400 HASSELL ROAD SE DECISION MADE: 19-OCT-06
SUITE 370 510(k) SUMMARY AVAILABLE FROM FDA
HOFFMAN ESTATES, IL 60169
DEVICE: LZI AMPHETAMINE-SPECIFIC ORAL FLUID HOMOGENEOUS ENZTME IMMUNOASS
LIN-ZHI INTERNATIONAL, INC. 510(k) NO: K063024(TRADITIONAL)
ATTN: MARIE LIN PHONE NO : 408-732-3856
687 NORTH PASTORIA AVE. SE DECISION MADE: 30-OCT-06
SUNNYVALE, CA 94085-2917 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MASTALEX -MRSA, MODEL RST501
MAST GROUP LTD. 510(k) NO: K062864(TRADITIONAL)
ATTN: BARBARA A LEE PHONE NO : 00 44 1519337277
MAST HOUSE, DERBY RD. SE DECISION MADE: 18-OCT-06
BOOTLE, MERSEYSIDE, UNITED KINGDOM510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDHOT MTI 2000 THERMAL IMAGING SYSTEM
MEDHOT THERMAL IMAGING, INC. 510(k) NO: K063047(TRADITIONAL)
ATTN: SID MATHUR PHONE NO : 516-482-9001
55 NORTHERN BLVD. SE DECISION MADE: 19-OCT-06
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021 THIRD PARTY REVIEW
DEVICE: PASS 2 SPINAL SYSTEM
MEDICREA 510(k) NO: K062136(TRADITIONAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD SE DECISION MADE: 06-OCT-06
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPERMSLOW
MEDICULT A/S 510(k) NO: K061145(TRADITIONAL)
ATTN: RONALD G LEONARDI PHONE NO : 858-586-0751
9915 CAM. CHIRIMOLLA SE DECISION MADE: 02-OCT-06
SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QANGIO CT
MEDIS MEDICAL IMAGING SYSTEMS, B.V510(k) NO: K062386(TRADITIONAL)
ATTN: J.I. HOLLANDER PHONE NO : 31 71 5223244
9 SCHUTTERSVELD SE DECISION MADE: 05-OCT-06
LEIDEN, NETHERLANDS 2316 XG 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IRI INTEGRATED RETINAL IMAGER
MEDIVISION MEDICAL IMAGING, LTD. 510(k) NO: K062295(TRADITIONAL)
ATTN: AHAVA STEIN PHONE NO : 972 976 70002
20 HATA' AS ST SE DECISION MADE: 20-OCT-06
KFAR SABA, ISRAEL 44425 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MANUEL SAFTEY SYRINGE PARTS 1 & 2
MEDSAFE ASA 510(k) NO: K060772(TRADITIONAL)
ATTN: NILS GUNNARSSON PHONE NO : 472 322 3614
FORSKNINGSVEIN 2A N-0373 SE DECISION MADE: 16-OCT-06
OSLO, NORWAY 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K060615(TRADITIONAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 25-OCT-06
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SELECTSITE C304 DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59, C
MEDTRONIC, INC. 510(k) NO: K061416(TRADITIONAL)
ATTN: MICHELLE NIVALA PHONE NO : 763-505-7863
1015 GRAMSIE ROAD SE DECISION MADE: 25-OCT-06
SHOREVIEW, MN 55126-3082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIOBLATE NAVIGATOR TISSUE DISSECTION DEVICE
MEDTRONIC, INC. 510(k) NO: K062727(TRADITIONAL)
ATTN: SCOTT CANDY PHONE NO : 763-391-9941
7601 NORTHLAND DRIVE SE DECISION MADE: 11-OCT-06
BROOKLYN PARK, MN 55428-1088 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER
MENTOR CORPORATION 510(k) NO: K062421(TRADITIONAL)
ATTN: NICOLA SELLEY PHONE NO : 805-879-6301
201 MENTOR DRIVE SE DECISION MADE: 10-OCT-06
SANTA BARBARA, CA 93111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISAGE PACS/CS, RELEASE VERSION 4.1
MERCURY COMPUTER SYSTEMS, INC 510(k) NO: K062490(TRADITIONAL)
ATTN: RICHARD GLASHEEN PHONE NO : 978-967-1843
199 RIVERNECK ROAD, SE DECISION MADE: 27-OCT-06
CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEM
MILLICORE AB 510(k) NO: K062302(TRADITIONAL)
ATTN: ROSINA ROBINSON PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 06-OCT-06
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045
MINITUBE OF AMERICA, INC 510(k) NO: K050197(TRADITIONAL)
ATTN: FREDERICK T RIKKERS PHONE NO : 608-255-4440
ONE EAST MAIN STREET, STE 300 SE DECISION MADE: 06-OCT-06
MADISON, WI 53703 510(k) STATEMENT
DEVICE: ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL FS 1000 RF
MISONIX, INC. 510(k) NO: K062471(TRADITIONAL)
ATTN: RONALD R MANNA PHONE NO : 631-694-9555
1938 NEW HIGHWAY SE DECISION MADE: 26-OCT-06
FARMINGDALE, NY 11735 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOLDEX HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASK
MOLDEX/METRIC, INC. 510(k) NO: K062663(ABBREVIATED)
ATTN: WILLIAM WAWRZYNIAK PHONE NO : 310-837-6500
10111 WEST JEFFERSON BLVD. SE DECISION MADE: 11-OCT-06
CULVER CITY, CA 90232 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE; POWDER FRE
MOLNLYCKE HEALTH CARE, INC. 510(k) NO: K062138(SPECIAL)
ATTN: STEVE DOWDLEY PHONE NO : 678-250-7930
5550 PEACHTREE PKWY STE 500 SE DECISION MADE: 05-OCT-06
NORCROSS, GA 30092 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEOTRACT ANCHOR
NEOTRACT, INC. 510(k) NO: K061700(TRADITIONAL)
ATTN: KEVIN MACDONALD PHONE NO : 925-487-2122
4472 WILLOW ROAD SE DECISION MADE: 26-OCT-06
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
PLEASANTON, CA 94588
DEVICE: MODIFICATION TO SUPEROPEN 0.23T, MODEL NAM-P023A
NEUSOFT MEDICAL SYSTEMS CO., LTD. 510(k) NO: K062860(SPECIAL)
ATTN: TIAN YANFANG PHONE NO : 862 483 660649
NO.3-11, WENHUA ROAD SE DECISION MADE: 27-OCT-06
HEPING DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA
SHENYANG, LIAONING, CHINA 110004
DEVICE: DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR (DHELP); DEFOGGING END
NEW WAVE SURGICAL CORPORATION 510(k) NO: K062779(TRADITIONAL)
ATTN: SID MATHUR PHONE NO : 516-482-9001
55 NORTHERN BLVD. SE DECISION MADE: 05-OCT-06
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11011 THIRD PARTY REVIEW
DEVICE: DENSHIELD TREATMENT FOR SENSITIVE TEETH
NOVAMIN TECHNOLOGY, INC. 510(k) NO: K061359(TRADITIONAL)
ATTN: DAVID C GREENSPAN PHONE NO : 386-418-1551
13709 PROGRESS BLVD., STE. 23 SE DECISION MADE: 18-OCT-06
ALACHUA, FL 32615 510(k) STATEMENT
DEVICE: NOVASPINE POWERED SUCTION PUMP, MODEL PRO-I
NOVASPINE LLC 510(k) NO: K062456(TRADITIONAL)
ATTN: DINA L WEISSMAN PHONE NO : 203-736-8631
P.O. BOX 205 SE DECISION MADE: 16-OCT-06
DERBY, CT 06418 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117
OLYMPUS AMERICA, INC. 510(k) NO: K061575(TRADITIONAL)
ATTN: BEV HARDING PHONE NO : 972-556-9697
3131 WEST ROYAL LN. SE DECISION MADE: 05-OCT-06
IRVING, TX 75063-3104 510(k) STATEMENT
DEVICE: E-VIEW FLUOROSCOPY SYSTEM, MODEL CS-50
OMEGA MEDICAL IMAGING, INC. 510(k) NO: K062647(TRADITIONAL)
ATTN: JAMES A PRINCEHORN PHONE NO : 407-323-9400
675 HICKMAN CIRCLE SE DECISION MADE: 20-OCT-06
SANFORD, FL 32771 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMI RETRACTABLE SAFTEY SYRINGE, VARIOUS
OMI MANUFACTURING PTY., LTD. 510(k) NO: K060971(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 24-OCT-06
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTIMEDICA LASER INDIRECT OPHTHALMOSCOPE
OPTIMEDICA CORPORATION 510(k) NO: K062336(TRADITIONAL)
ATTN: JUDY F GORDON PHONE NO : 949-715-0609
733 BOLSANA DRIVE SE DECISION MADE: 19-OCT-06
LAGUNA BEACH, CA 92651 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RTVUE
OPTOVUE, INC. 510(k) NO: K062552(TRADITIONAL)
ATTN: JAY WEI PHONE NO : 510-623-8868
41752 CHRISTY STREET SE DECISION MADE: 06-OCT-06
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: OSTEOBOOST-BMA
ORTHOS LIMITED 510(k) NO: K062260(TRADITIONAL)
ATTN: ALAN RORKE PHONE NO : 44 127 5376377
3 THE STABLES LEIGH CT PILL RD SE DECISION MADE: 26-OCT-06
ABBOTS LEIGH 510(k) SUMMARY AVAILABLE FROM FDA
BRISTOL, NORTH SOMERSET, UNITED KINGDOM BS8 3RA
DEVICE: SUPER ORTHODONTIC SCREW
OSSTEM IMPLANT CO LTD 510(k) NO: K062156(TRADITIONAL)
ATTN: CATHRYN CAMBRIA PHONE NO : 770-396-5909
5536 TROWBRIDGE DRIVE SE DECISION MADE: 20-OCT-06
DUNWOODY, GA 30338 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEOMED EXTENDED 2.0/2.4CANNULATED SCREW SYSTEM
OSTEOMED L.P. 510(k) NO: K062863(TRADITIONAL)
ATTN: DAWN D TINDALL PHONE NO : 972-677-4600
3885 ARAPAHO RD. SE DECISION MADE: 31-OCT-06
ADDISON, TX 75001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PAJUNK MULTISTIM SENSOR NERVE STIMULATORS
PAJUNK GMBH MEDIZINTECHNOLOGIE 510(k) NO: K061172(TRADITIONAL)
ATTN: LYNETTE L HOWARD PHONE NO : 352-383-8333
106 EAST 5TH AVENUE SE DECISION MADE: 17-OCT-06
MOUNT DORA, FL 32757 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADAPTABLE MONOPOLAR ADAPTABLE AND/OR RETRACTABLE ELECTRODES
PAJUNK GMBH MEDIZINTECHNOLOGIE 510(k) NO: K062047(SPECIAL)
ATTN: CHRISTIAN QUASS PHONE NO : 497 704 9291586
KARL-HALL-STRASSE 01 SE DECISION MADE: 05-OCT-06
GEISINGEN, BADEN-WURTTEMBERG, GERM510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERESS CANNULA AND MODULAR VERESS CANNULA
PAJUNK GMBH MEDIZINTECHNOLOGIE 510(k) NO: K062097(TRADITIONAL)
ATTN: CHRISTIAN QUASS PHONE NO : 497 704 9291586
KARL-HALL-STRASSE 1 SE DECISION MADE: 13-OCT-06
GEISINGEN, BADEN-WURTTEMBERG, GERM510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOUTHKOTE ORAL MOISTURIZER, MODEL 50930-098
PARNELL PHARMACEUTICALS, INC. 510(k) NO: K062653(TRADITIONAL)
ATTN: FRANCIS W PARNELL PHONE NO : 415-256-1800
1525 FRANCISCO BLVD., STE. 15 SE DECISION MADE: 27-OCT-06
SAN RAFAEL, CA 94901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLARCOAT
PATTON SURGICAL CORP. 510(k) NO: K052907(TRADITIONAL)
ATTN: VIKKI BALLESTEROS PHONE NO : 512-329-0469
6300 BRIDGEPOINT PKWY. SE DECISION MADE: 16-OCT-06
BLDG. 2, STE. 420 510(k) SUMMARY AVAILABLE FROM FDA
AUSTIN, TX 78730
DEVICE: SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SE
PENTRON CLINICAL TECHNOLOGIES 510(k) NO: K060889(TRADITIONAL)
ATTN: GREG MOREAU PHONE NO : 203-265-7397
68-70 NORTH PLAINS INDUSTRIAL SE DECISION MADE: 27-OCT-06
ROAD 510(k) SUMMARY AVAILABLE FROM FDA
WALLINGFORD, CT 06492
DEVICE: CARDIOFLON, CARDIOXYL
PETERS SURGICAL 510(k) NO: K060163(SPECIAL)
ATTN: ANNIE LASSERRE PHONE NO : 331 481 06259
Z.I. LES VIGNES SE DECISION MADE: 11-OCT-06
42 RUE BENOIT FRACHON 510(k) SUMMARY AVAILABLE FROM FDA
BOBIGNY, FRANCE 93013
DEVICE: OPTIME, SINUSORB PGA
PETERS SURGICAL 510(k) NO: K062366(TRADITIONAL)
ATTN: ANNIE LASSERRE PHONE NO : 33 148 106259
42 RUE BENOIT FRACHON SE DECISION MADE: 02-OCT-06
BOBIGNY, FRANCE 93013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TELEVISIT
PHD MEDICAL 510(k) NO: K062338(TRADITIONAL)
ATTN: NANCY RUTH PHONE NO : 905 689 3980
4 INNOVATION DRIVE SE DECISION MADE: 25-OCT-06
DUNDAS, ON, CANADA L9H 7P3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MASIMO SET SPO2 MODULE FOR PHILIPS AND M3001A MULTI-MEASUREMENT
PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K062268(SPECIAL)
ATTN: DAVID OSBORN PHONE NO : 978-659-3178
3000 MINUTEMAN ROAD SE DECISION MADE: 18-OCT-06
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SERENO ELECTRONIC STETHOSCOPE
PISHON HIGH TECH CO., LTD. 510(k) NO: K062481(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854
P.O. BOX 7007 SE DECISION MADE: 16-OCT-06
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PIGALILEO TOTAL KNEE REPLACEMENT (TKR) SYSTEM
PLUS ORTHOPEDICS AG 510(k) NO: K061362(TRADITIONAL)
ATTN: PAMELA J WEAGRAFF PHONE NO : 508-528-1745
18 BRIDIE LANE SE DECISION MADE: 06-OCT-06
NORFOLK, MA 02056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NASOPORE EAR, MODELS ND04, ND05
POLYGANICS BV 510(k) NO: K062540(TRADITIONAL)
ATTN: JAN NIEUWENHUIS PHONE NO : 315 058 86588
L.J. ZIELSTRAWEG 1 SE DECISION MADE: 18-OCT-06
GRONINGEN, NETHERLANDS 9713-GX 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: URASSIST
PREFERRED MEDICAL DEVICES, INC. 510(k) NO: K062061(TRADITIONAL)
ATTN: PENELOPE GRECO PHONE NO : 508-843-0282
8 GRAY LODGE ROAD SE DECISION MADE: 05-OCT-06
KITTERY, ME 03904 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PREMIER SELF-ETCHING ENAMEL SEALANT
PREMIER DENTAL PRODUCTS CO. 510(k) NO: K061997(TRADITIONAL)
ATTN: VINCE D'ALESSANDRO PHONE NO : 610-239-6000
1710 ROMANO DR. SE DECISION MADE: 04-OCT-06
PLYMOUTH MEETING, PA 19462 510(k) STATEMENT
DEVICE: PREMIER SELF-ETCHING BOND ENHANCER
PREMIER DENTAL PRODUCTS CO. 510(k) NO: K061998(TRADITIONAL)
ATTN: VINCE D'ALESSANDRO PHONE NO : 610-239-6000
1710 ROMANO DR. SE DECISION MADE: 04-OCT-06
PLYMOUTH MEETING, PA 19462 510(k) STATEMENT
DEVICE: MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER
QUANTIMETRIX CORP. 510(k) NO: K062751(SPECIAL)
ATTN: BERNICE NAVARRO PHONE NO : 310-536-0006
2005 MANHATTAN BEACH BLVD. SE DECISION MADE: 03-OCT-06
REDONDO BEACH, CA 90278-1205 510(k) STATEMENT
DEVICE: QUANTIMETRIX NICOSURE COTININE URINE CONTROL
QUANTIMETRIX CORP. 510(k) NO: K062942(TRADITIONAL)
ATTN: BERNICE NAVARRO PHONE NO : 310-536-0006
2005 MANHATTAN BEACH BLVD. SE DECISION MADE: 30-OCT-06
REDONDO BEACH, CA 90278-1205 510(k) STATEMENT
DEVICE: ABL8X7 FLEX
RADIOMETER MEDICAL APS 510(k) NO: K051968(TRADITIONAL)
ATTN: LENE MEINECHE MARNAES PHONE NO : 45 38 273827
AKANDEVEJ 21 SE DECISION MADE: 16-OCT-06
BRONSHOJ, DENMARK DK-2700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REMCORE REMOTE CONTROLLED OXYGEN REGULATOR
REMCORE, INC. 510(k) NO: K060265(TRADITIONAL)
ATTN: KEVIN JORCZAK PHONE NO : 413-222-4852
14 BOND STREET SE DECISION MADE: 25-OCT-06
BOSTON, MA 02118 510(k) STATEMENT
DEVICE: DIRECT DIGITAL RADIOGRAPHY CCD IMAGING SENSOR, NAOMI
RF SYSTEMS LAB. 510(k) NO: K062376(TRADITIONAL)
ATTN: CLAUDE D BERTHOIN PHONE NO : 386-672-0450
110 E. GRANADA BLVD. SE DECISION MADE: 27-OCT-06
SUITE 208 510(k) STATEMENT
ORMOND BEACH, FL 32164
DEVICE: HABIB 4X LAPAROSCOPIC
RITA MEDICAL SYSTEMS 510(k) NO: K062935(TRADITIONAL)
ATTN: DARRIN R UECKER PHONE NO : 510-771-0403
46421 LANDING PARKWAY SE DECISION MADE: 13-OCT-06
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PRECINORM CK-MB AND PRECIPATH CK-MB CONTROLS
ROCHE DIAGNOSTICS CORP. 510(k) NO: K062972(SPECIAL)
ATTN: KERWIN L KAUFMAN PHONE NO : 317-521-7637
9115 HAGUE RD. SE DECISION MADE: 13-OCT-06
P.O. BOX 50416 510(k) SUMMARY AVAILABLE FROM FDA
INDIANAPOLIS, IN 46250-0457
DEVICE: SAGEMAX Z-BLANK
SAGEMAX BIOCERAMICS, INC. 510(k) NO: K062695(TRADITIONAL)
ATTN: LARRY DANG PHONE NO : 425-223-4166
11061 NE 2ND STREET SE DECISION MADE: 20-OCT-06
SUITE 168 510(k) SUMMARY AVAILABLE FROM FDA
BELLEVUE, WA 98004
DEVICE: K-SPRAY, MODEL 085-2715
SCICAN 510(k) NO: K062418(TRADITIONAL)
ATTN: BRENDA MURPHY PHONE NO : 416 446 2797
1440 DON MILLS RD. SE DECISION MADE: 19-OCT-06
TORONTO, ONTARIO, CANADA M3B 3P9 510(k) STATEMENT
DEVICE: MALIBU SPINAL SYSTEM
SEASPINE, INC. 510(k) NO: K061342(TRADITIONAL)
ATTN: DIANA SMITH PHONE NO : 760-727-8399
2302 LA MIRADA DR. SE DECISION MADE: 25-OCT-06
VISTA, CA 92081-7862 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BREATH ALCOHOL TEST SYSTEM, MODEL AL-5000
SENTECH KOREA CORP. 510(k) NO: K061922(TRADITIONAL)
ATTN: DANIEL PARK PHONE NO : 82 1 5812295
1460-1 SEOYANG B/D SE DECISION MADE: 30-OCT-06
SEOCHO-DONG, SEOCHO-KU 510(k) SUMMARY AVAILABLE FROM FDA
SEOUL, REPUBLIC OF KOREA 13786 THIRD PARTY REVIEW
DEVICE: CST61 HIGH SPEED TURBINE HANDPIECE
SHANGHAI DENTAL INSTRUMENT FACTORY510(k) NO: K063110(TRADITIONAL)
ATTN: JAY MANSOUR PHONE NO : 678-908-8180
845 ARONSON LAKE COURT SE DECISION MADE: 26-OCT-06
ROSWELL, GA 30075 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BRANSIST SAFIRE
SHIMADZU CORP. 510(k) NO: K062360(ABBREVIATED)
ATTN: RANDAL WALKER PHONE NO : 310-217-8855
20101 SOUTH VERMONT AVE. SE DECISION MADE: 05-OCT-06
TORRANCE, CA 90502-1328 510(k) STATEMENT
DEVICE: SYNGO DUAL ENERGY
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K062351(TRADITIONAL)
ATTN: GARY JOHNSON PHONE NO : 610-448-1778
51 VALLEY STREAM PKWY. SE DECISION MADE: 05-OCT-06
E-50 510(k) SUMMARY AVAILABLE FROM FDA
MALVERN, PA 19355
DEVICE: SINCLAIR SEBORRHEA EMULSION
SINCLAIR PHARMACEUTICALS, LTD. 510(k) NO: K050158(TRADITIONAL)
ATTN: MICHEAL KILLEEN PHONE NO : 011 44 1483428611
BOROUGH RD. SE DECISION MADE: 11-OCT-06
GODALMING, SURREY, UNITED KINGDOM 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SBI TRIHEDRON MTP HEMI GT
SMALL BONE INNOVATIONS INC. 510(k) NO: K062040(TRADITIONAL)
ATTN: ROBERT HOEHN PHONE NO : 215-428-1791
505 PARK AVE., 14TH FLOOR SE DECISION MADE: 03-OCT-06
NEW YORK, NY 10022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SBI CARPAL FUSION PLATE
SMALL BONE INNOVATIONS INC. 510(k) NO: K062903(SPECIAL)
ATTN: ROBERT HOEHN PHONE NO : 215-428-1791
505 PARK AVE., 14TH FLOOR SE DECISION MADE: 20-OCT-06
NEW YORK, NY 10022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200
SMISSON-CARTLEDGE BIOMEDICAL LLC 510(k) NO: K052055(TRADITIONAL)
ATTN: JULIE STEPHENS PHONE NO : 678-513-0693
111 LAUREL RIDGE DRIVE SE DECISION MADE: 26-OCT-06
ALPHARETTA, GA 30004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORTEX EPIDURAL CATHETER
SMITHS MEDICAL ASD, INC. 510(k) NO: K062005(SPECIAL)
ATTN: CYNTHIA ENGELHARDT PHONE NO : 603-352-3812
10 BOWMAN DR. SE DECISION MADE: 18-OCT-06
KEENE, NH 03431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTIONAL REMOTE CONTROL, MODEL RC-115, FOR PORTABLE X-RAY SYSTEM
SOURCE-RAY, INC. 510(k) NO: K062472(TRADITIONAL)
ATTN: RAY MANEZ PHONE NO : 631-244-8200
167 KEYLAND CT. SE DECISION MADE: 31-OCT-06
BOHEMIA, NY 11716 510(k) STATEMENT
DEVICE: D-SPECT CARDIAC SCANNER SYSTEM
SPECTRUM DYNAMICS LTD. 510(k) NO: K062450(TRADITIONAL)
ATTN: AHAVA STEIN PHONE NO : 972 9 7670002
20 HATA'AS ST. SE DECISION MADE: 20-OCT-06
KFAR SABA, ISRAEL 44425 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEOPORE TCP
SPINECRAFT, INC. 510(k) NO: K062496(TRADITIONAL)
ATTN: AMI AKALLAL-ASSAD PHONE NO : 708-531-9700
2215 ENTERPRISE DRIVE SE DECISION MADE: 19-OCT-06
SUITE 1504 510(k) SUMMARY AVAILABLE FROM FDA
WESTCHESTER, IL 60154
DEVICE: MODIFICATION TO ENDO-EASE
SPIRUS MEDICAL, INC. 510(k) NO: K062805(SPECIAL)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552
5 WHITCOMB AVENUE SE DECISION MADE: 13-OCT-06
AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REFLEXION SPIRAL VARIABLE RADIUS CATHETER, MODEL 402804
ST. JUDE MEDICAL 510(k) NO: K062251(TRADITIONAL)
ATTN: GLENN JACQUES PHONE NO : 952-933-4700
14901 DEVEAU PL. SE DECISION MADE: 20-OCT-06
MINNETONKA, MN 55345-2126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STARION INSTRUMENTS THERMAL LITIGATING SHEARS
STARION INSTRUMENTS 510(k) NO: K062257(SPECIAL)
ATTN: BRIAN GRIGSBY PHONE NO : 408-741-8773
20665 4TH ST. SE DECISION MADE: 10-OCT-06
SARATOGA, CA 95070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STELLARTECH 100 COAGULATION SYSTEM
STELLARTECH RESEARCH CORP. 510(k) NO: K061544(TRADITIONAL)
ATTN: JAMES R SANTOS PHONE NO : 408-331-3000
1350 BORDEAUX DRIVE SE DECISION MADE: 13-OCT-06
SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION
STEREOTAXIS, INC. 510(k) NO: K060967(TRADITIONAL)
ATTN: DENNIS POZZO PHONE NO : 314-678-6136
4320 FOREST PARK AVENUE SE DECISION MADE: 19-OCT-06
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
ST. LOUIS, MO 63108
DEVICE: VERIFY SYSTEM 1 BIOLOGICAL MONITORING KIT, VERSION 3
STERIS CORPORATION 510(k) NO: K062269(SPECIAL)
ATTN: CYNTHIA J.M. NOLTE PHONE NO : 919-859-4207
49 PLAIN STREET SE DECISION MADE: 11-OCT-06
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER RF PARALLEL BIPOLAR ADAPTOR CABLE
STRYKER INSTRUMENTS 510(k) NO: K061660(TRADITIONAL)
ATTN: JENNIFER HOFFMAN PHONE NO : 269-323-7700
4100 EAST MILHAM AVE. SE DECISION MADE: 10-OCT-06
KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER ARIA PNEUMATIC SYSTEM
STRYKER INSTRUMENTS 510(k) NO: K061725(TRADITIONAL)
ATTN: VALERIE FRANCK PHONE NO : 269-323-7700
4100 EAST MILHAM AVE. SE DECISION MADE: 26-OCT-06
KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIO + SPINAL SYSTEM
STRYKER SPINE 510(k) NO: K062698(SPECIAL)
ATTN: SIMONA VOIC PHONE NO : 201-760-8145
2 PEARL COURT SE DECISION MADE: 11-OCT-06
ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO STRYKER SPINE OASYS SYSTEM
STRYKER SPINE 510(k) NO: K062853(SPECIAL)
ATTN: SIMONA VOIC PHONE NO : 201-760-8145
2 PEARL COURT SE DECISION MADE: 24-OCT-06
ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASORING* VRC VASCULAR RING CONNECTOR
SUNWEI TECH CO. LTD. 510(k) NO: K061626(TRADITIONAL)
ATTN: JOSEPH J CHANG PHONE NO : 832-545-8399
7128 STAFFORDSHIRE STREET SE DECISION MADE: 05-OCT-06
HOUSTON, TX 77030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED)
SUQIAN GREEN GLOVE CO., LTD. 510(k) NO: K062882(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441
NO.209 BEI SI HUAN ZHONG RD. SE DECISION MADE: 20-OCT-06
RM.1606 BLDG.1 JIANXIANG YUAN 510(k) SUMMARY AVAILABLE FROM FDA
BEIJING, CHINA 100083
DEVICE: ENSEAL PTC TISSUE SEATING SEALING DEVICE
SURGRX INC 510(k) NO: K062949(SPECIAL)
ATTN: LINDA OLESON PHONE NO : 650-482-2400
101 SAGINAW DRIVE SE DECISION MADE: 18-OCT-06
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENSEAL PTC TISSUE SEALING DEVICE
SURGRX, INC. 510(k) NO: K063097(SPECIAL)
ATTN: LINDA OLESON PHONE NO : 650-482-2400
101 SAGINAW DR. SE DECISION MADE: 18-OCT-06
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUPERSTITCH 5F, 12F, AND EL
SUTURA, INC. 510(k) NO: K062125(SPECIAL)
ATTN: GERARD J PRUD'HOMME PHONE NO : 202-637-5735
555 THIRTEENTH ST. NW SE DECISION MADE: 19-OCT-06
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES LCP DISTAL FEMUR PLATES
SYNTHES (USA) 510(k) NO: K062564(TRADITIONAL)
ATTN: SHERI L MUSGNUNG PHONE NO : 610-719-6940
1301 GOSHEN PKWY SE DECISION MADE: 19-OCT-06
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLEXITOUCH SYSTEM
TACTILE SYSTEMS TECHNOLOGY INC 510(k) NO: K062818(TRADITIONAL)
ATTN: PHILLIP R ROSE PHONE NO : 952-224-4060
4824 PARK GLEN RD. SE DECISION MADE: 06-OCT-06
MINNEAPOLIS, MN 55416 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BELMAX CM MODEL X168
TAKARA BELMONT USA, INC. 510(k) NO: K062529(TRADITIONAL)
ATTN: ROBERT SCHIFF PHONE NO : 973-227-1830
1129 BLOOMFIELD AVENUE SE DECISION MADE: 05-OCT-06
WEST CALDWELL, NJ 07006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO PINNACLE ROII HIFLOW INTRODUCER SHEATH
TERUMO MEDICAL CORP. 510(k) NO: K062446(SPECIAL)
ATTN: MARK UNTERREINER PHONE NO : 410-392-7213
950 ELKTON BLVD. SE DECISION MADE: 23-OCT-06
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO GLIDESHEATH
TERUMO MEDICAL CORP. 510(k) NO: K062858(SPECIAL)
ATTN: MARK UNTERREINER PHONE NO : 410-392-7213
950 ELKTON BLVD. SE DECISION MADE: 20-OCT-06
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THERMASSAGE
THERMAGE, INC. 510(k) NO: K061001(TRADITIONAL)
ATTN: PAMELA M BUCKMAN PHONE NO : 510-782-2286
25881 INDUSTRIAL BLVD. SE DECISION MADE: 12-OCT-06
HAYWARD, CA 94545 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUPERCATH V
TOGO MEDIKIT CO., LTD. 510(k) NO: K052267(TRADITIONAL)
ATTN: FUMIAKI KANAI PHONE NO : 813 381 88577
4-2-1 YUSHIMA BUNKYO-KU SE DECISION MADE: 27-OCT-06
TOKYO, JAPAN 113-0034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGPRO, MODEL R30
TONICA ELEKTRONIK A/S 510(k) NO: K061645(TRADITIONAL)
ATTN: LISE TERKELSEN PHONE NO : 45 449 98444
LUCERNEMARKEN 15 SE DECISION MADE: 31-OCT-06
FARUM, DENMARK 3520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TORBOT VASCULAR COMPRESSION GARMENTS
TORBUT GROUP, INC. 510(k) NO: K061411(TRADITIONAL)
ATTN: GREG JOHNSON PHONE NO : 419-724-1475
653 MIAMI STREET SE DECISION MADE: 18-OCT-06
TOLEDO, OH 43605 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K062722(TRADITIONAL)
ATTN: CYNTHIA C KNAPP PHONE NO : 800-871-8909
982 KEYNOTE CIRCLE SUITE 6 SE DECISION MADE: 20-OCT-06
CLEVELAND, OH 44131 510(k) STATEMENT
DEVICE: SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K062783(TRADITIONAL)
ATTN: CYNTHIA C KNAPP PHONE NO : 800-871-8909
982 KEYNOTE CIRCLE SUITE 6 SE DECISION MADE: 26-OCT-06
CLEVELAND, OH 44131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
TREK DIAGNOSTIC SYSTEMS, LTD. 510(k) NO: K062681(TRADITIONAL)
ATTN: CYNTHIA C KNAPP PHONE NO : 800-871-8909
982 KEYNOTE CIRCLE SE DECISION MADE: 13-OCT-06
SUITE 6 510(k) STATEMENT
BROOKLYN HEIGHTS, OH 44131
DEVICE: DIACHEX BLOOD GLUCOSE MONITORING SYSTEM
TYSON BIORESEARCH, INC. 510(k) NO: K062829(SPECIAL)
ATTN: WEN-HAI TSAI PHONE NO : 886 375 85988
5 F., # 22, KE TUNG RD., SE DECISION MADE: 10-OCT-06
SCIENCE BASED INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
CHUN-NAN, MIAO-LI COUNTY, CHINA (TAIWAN) 350
DEVICE: AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS
UNITED STATES SURGICAL, A DIVISION510(k) NO: K062850(SPECIAL)
ATTN: FRANK GIANELLI PHONE NO : 203-492-5352
150 GLOVER AVE. SE DECISION MADE: 23-OCT-06
NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: D-STAT DRY HEMOSTATIC BANDAGE
VASCULAR SOLUTIONS, INC. 510(k) NO: K061219(TRADITIONAL)
ATTN: JULIE TAPPER PHONE NO : 763-656-4228
6464 SYCAMORE COURT SE DECISION MADE: 06-OCT-06
MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GRANDIO SEAL
VOCO GMBH 510(k) NO: K062344(ABBREVIATED)
ATTN: MICHAEL SUES PHONE NO : 49 472 1719214
ANTON-FLETTNER-STRASSE 1-3 SE DECISION MADE: 02-OCT-06
CUXHAVEN, GERMANY D-27472 510(k) STATEMENT
DEVICE: STERILE POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLO
WEAR SAFE MALAYSIA SDN. BHD. 510(k) NO: K062778(TRADITIONAL)
ATTN: LIM L BUNG PHONE NO : 603 317 63525
LOT 1, LEBOH HISHAMUDDIN SATU, SE DECISION MADE: 27-OCT-06
NORTH KLANG STRAITS IND. AREA 510(k) STATEMENT
PORT KLANG, SELANGOR, D.E., MALAYSIA 42000
DEVICE: POWERTOME PERIOTOME
WESTPORT MEDICAL, INC. 510(k) NO: K063007(TRADITIONAL)
ATTN: RALPH WELLS PHONE NO : 503-510-7560
6603 RIPPLING BROOK DRIVE SE SE DECISION MADE: 17-OCT-06
SALEM, OR 97317 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: WU'S 3-WHEELED NEO SCOOTER, MODEL WT-T3E
WU'S TECH CO., LTD. 510(k) NO: K062790(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 11-OCT-06
HSIN-CHU CITY, CHINA (TAIWAN) ROC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIMMER CONTOUR CERAMIC ABUTMENT, MODELS ZRA341S, ZRA342S, KRA451
ZIMMER DENTAL INC. 510(k) NO: K061847(TRADITIONAL)
ATTN: WILLIAM FISHER PHONE NO : 760-929-4300
1900 ASTON AVE. SE DECISION MADE: 12-OCT-06
CARLSBAD, CA 92008-7308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANATOMICAL SHOULDER FRACTURE SYSTEM
ZIMMER GMBH 510(k) NO: K062029(TRADITIONAL)
ATTN: MASON W ROBBINS PHONE NO : 574-371-8065
P.O. BOX 708 SE DECISION MADE: 31-OCT-06
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED FLEX F
ZIMMER, INC. 510(k) NO: K062768(SPECIAL)
ATTN: ANTHONY FRANCALANCIA PHONE NO : 574-372-4570
P.O. BOX 708 SE DECISION MADE: 13-OCT-06
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 271
TOTAL WITH SUMMARIES 239
TOTAL WITH STATEMENTS 32
Updated March 21, 2007
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