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510(k)s Final Decisions Rendered for November 2001 |
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SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE)
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD 01-NOV-2001 THROUGH 30-NOV-2001
DEVICE: SF SH CATHETER, MODEL R65-945
A & A MEDICAL, INC. 510(k) NO: K013437(TRADITIONAL)
ATTN: JAY MANSOUR PHONE NO : 770-343-8400
9370 INDUSTRIAL TRACE SE DECISION MADE: 19-NOV-01
ALPHARETTA, GA 30004-3383 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL
A & A MEDICAL, INC. 510(k) NO: K013491(TRADITIONAL)
ATTN: JAY MANSOUR PHONE NO : 770-343-8400
9370 INDUSTRIAL TRACE SE DECISION MADE: 19-NOV-01
ALPHARETTA, GA 30004-3383 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEPARIN COATED MINIATURE CENTRIFUGAL BYPASS PUMP SYSTEM;MODEL #C
A-MED SYSTEMS, INC. 510(k) NO: K013393(SPECIAL)
ATTN: CYNTHIA G ROYSTER PHONE NO : 916-375-7400
2491 BOATMAN AVE. SE DECISION MADE: 09-NOV-01
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACON BAR ONE STEP BARBITURATES TEST STRIP, ACON BAR ONE STEP BAR
ACON LABORATORIES, INC. 510(k) NO: K012824(TRADITIONAL)
ATTN: EDWARD TUNG PHONE NO : 858-535-2030
4108 SORRENTO VALLEY BLVD. SE DECISION MADE: 09-NOV-01
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACRYDERM SILVER ANTTIMICROBIAL WOUND GEL MODEL# A-002101
ACRYMED, INC. 510(k) NO: K011994(TRADITIONAL)
ATTN: BRUCE GIBBINS PHONE NO : 503-624-9830
12232 SW GARDEN PLACE SE DECISION MADE: 08-NOV-01
PORTLAND, OR 97223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONGRUENT BONE PLATE SYSTEM
ACUMED, INC. 510(k) NO: K012655(TRADITIONAL)
ATTN: SHARI JEFFERS PHONE NO : 503-627-9957
10950 S.W. 5TH ST., SUITE 170 SE DECISION MADE: 07-NOV-01
BEAVERTON, OR 97005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SKYLIGHT IMAGING SYSTEM
ADAC LABORATORIES 510(k) NO: K013496(TRADITIONAL)
ATTN: DAVID KOLESAR PHONE NO : 408-468-3455
540 ALDER DR. SE DECISION MADE: 06-NOV-01
MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: GEMINI IMAGING SYSTEM
ADAC LABORATORIES 510(k) NO: K013521(TRADITIONAL)
ATTN: COLEEN A COLEMAN PHONE NO : 408-468-3051
540 ALDER DR. SE DECISION MADE: 07-NOV-01
MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ALTAIR MODEL, DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)
ADVANCED DIAGNOSTICS, INC. 510(k) NO: K013291(TRADITIONAL)
ATTN: STEVE HESLER PHONE NO : 425-222-7169
8112 304TH AVE. SE SE DECISION MADE: 14-NOV-01
PRESTON, WA 98050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MACS HMA ANTERIOR SPINAL STABILIZATION SYSTEM
AESCULAP, INC. 510(k) NO: K011556(TRADITIONAL)
ATTN: LISA M MILLINGTON PHONE NO : 610-791-6882
3773 CORPORATE PKWY. SE DECISION MADE: 16-NOV-01
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADC PEDIATRIC
AGFA CORP. 510(k) NO: K012750(TRADITIONAL)
ATTN: T. WHIT ATHEY PHONE NO : 301-770-9590
12300 TWINBROOK PKWY,STE 625 SE DECISION MADE: 14-NOV-01
ROCKVILLE, MD 20852 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRYSTAR, MODEL 4500M
AGFA CORP. 510(k) NO: K012941(TRADITIONAL)
ATTN: T. WHIT ATHEY PHONE NO : 301-770-9590
12300 TWINBROOK PKWY,STE 625 SE DECISION MADE: 29-NOV-01
ROCKVILLE, MD 20852 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SINGLE DOSE DISPENSING PIN, MODEL 2201
ALARIS MEDICAL SYSTEMS, INC. 510(k) NO: K013087(TRADITIONAL)
ATTN: RENEE L FLUET PHONE NO : 858-458-7563
10221 WATERIDGE CIR. SE DECISION MADE: 13-NOV-01
SAN DIEGO, CA 92121-2733 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TST CONTROL INTEGRATOR FOR STEAM STERILIZERS
ALBERT BROWNE LTD. 510(k) NO: K002937(TRADITIONAL)
ATTN: CYNTHIA J.M. NOLTE PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 05-NOV-01
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPRESSIBLE LIMB SLEEVE
ALLIANCE MEDICAL CORP. 510(k) NO: K011192(TRADITIONAL)
ATTN: DON SELVEY PHONE NO : 480-763-5300
10232 SOUTH 51ST STREET SE DECISION MADE: 26-NOV-01
PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED AUTOSUTURE UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUME
ALLIANCE MEDICAL CORP. 510(k) NO: K012603(TRADITIONAL)
ATTN: DON SELVEY PHONE NO : 480-763-5300
10232 SOUTH 51ST. STREET SE DECISION MADE: 07-NOV-01
PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED ATHROSCOPICS BURS
ALLIANCE MEDICAL CORP. 510(k) NO: K012605(TRADITIONAL)
ATTN: DON SELVEY PHONE NO : 480-763-5300
10232 SOUTH 51ST. STREET SE DECISION MADE: 07-NOV-01
PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED STRYKER ARTHROSCOPIC SHAVERS
ALLIANCE MEDICAL CORP. 510(k) NO: K012635(TRADITIONAL)
ATTN: DON SELVEY PHONE NO : 480-763-5300
10232 SOUTH 51ST ST. SE DECISION MADE: 07-NOV-01
PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS
ALLIANCE MEDICAL CORP. 510(k) NO: K012638(TRADITIONAL)
ATTN: DON SELVEY PHONE NO : 480-763-5300
10232 SOUTH 51ST ST. SE DECISION MADE: 08-NOV-01
PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED DYONICS ARTHROSCOPIC BURS
ALLIANCE MEDICAL CORP. 510(k) NO: K012652(TRADITIONAL)
ATTN: DON SELVEY PHONE NO : 480-763-5300
10232 SOUTH 51ST. STREET SE DECISION MADE: 08-NOV-01
PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED DYONICS ARTHROSCOPIC SHAVERS
ALLIANCE MEDICAL, INC. 510(k) NO: K012611(TRADITIONAL)
ATTN: DON SELVEY PHONE NO : 480-763-5300
10232 SOUTH 51 STREET SE DECISION MADE: 07-NOV-01
PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCSSED LINVATEC SHAVERS
ALLIANCE MEDICAL, INC. 510(k) NO: K012613(TRADITIONAL)
ATTN: DON SELVEY PHONE NO : 480-763-5300
10232 SOUTH 51 STREET SE DECISION MADE: 07-NOV-01
PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED LINVATEC ARTHROSCOPIC BURS
ALLIANCE MEDICAL, INC. 510(k) NO: K012630(TRADITIONAL)
ATTN: DON SELVEY PHONE NO : 480-763-5300
10232 SOUTH 51 STREET SE DECISION MADE: 09-NOV-01
PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED PHACOEMULSIFICATION TIPS
ALLIANCE MEDICAL, INC. 510(k) NO: K012637(TRADITIONAL)
ATTN: DON SELVEY PHONE NO : 480-763-5300
10232 SOUTH 51 STREET SE DECISION MADE: 07-NOV-01
PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMEDITECH IMMUTEST DRUG SCREEN OPIATES
AMEDITECH, INC. 510(k) NO: K012483(TRADITIONAL)
ATTN: JOHN WU PHONE NO : 858-535-1968
10340 CAMINO SANTA FE, STE F SE DECISION MADE: 30-NOV-01
SAN DIEGO, CA 92121 510(k) STATEMENT
DEVICE: AMEDITECH IMMUTEST DRUG SCREEN AMPHETAMINE
AMEDITECH, INC. 510(k) NO: K012484(TRADITIONAL)
ATTN: JOHN WU PHONE NO : 858-535-1968
10340 CAMINO SANTA FE, STE F SE DECISION MADE: 30-NOV-01
SAN DIEGO, CA 92121 510(k) STATEMENT
DEVICE: AMEDITECH IMMUTEST DRUG SCREEN PCP
AMEDITECH, INC. 510(k) NO: K012582(TRADITIONAL)
ATTN: JOHN WU PHONE NO : 858-535-1968
10340 CAMINO SANTA FE, STE F SE DECISION MADE: 30-NOV-01
SAN DIEGO, CA 92121 510(k) STATEMENT
DEVICE: AMEDITECH IMMUTEST DRUG SCREEN METHAMPHETAMINE
AMEDITECH, INC. 510(k) NO: K012585(TRADITIONAL)
ATTN: JOHN WU PHONE NO : 858-535-1968
10340 CAMINO SANTA FE, STE F SE DECISION MADE: 16-NOV-01
SAN DIEGO, CA 92121 510(k) STATEMENT
DEVICE: 'RAPIDONE'-METHADONE TEST
AMERICAN BIO MEDICA CORP. 510(k) NO: K012164(TRADITIONAL)
ATTN: HENRY WELLS PHONE NO : 410-992-4734
9110 RED BRANCH ROAD SE DECISION MADE: 20-NOV-01
COLUMBIA, MD 21945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAPIDONE-ECSTASY TEST
AMERICAN BIO MEDICA CORP. 510(k) NO: K013180(TRADITIONAL)
ATTN: HENRY WELLS PHONE NO : 410-992-4734
9110 RED BRANCH ROAD SE DECISION MADE: 26-NOV-01
COLUMBIA, MD 21045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADC 656 ELECTRONIC STETHOSCOPE
AMERICAN DIAGNOSTIC CORP. 510(k) NO: K012304(TRADITIONAL)
ATTN: MARC BLITSTEIN PHONE NO : 516-273-9600
55 COMMERCE DR. SE DECISION MADE: 01-NOV-01
HAUPPAUGE, NY 11788 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO:MICRO TOUCH (R) POWDER FREE LATEX SURGICAL GLOVE
ANSELL HEALTHCARE PRODUCTS, INC. 510(k) NO: K013603(SPECIAL)
ATTN: JAMES R CHATTERTON PHONE NO : 330-833-2811
1875 HARSH AVENUE, SE SE DECISION MADE: 13-NOV-01
MASSILLON, OH 44646 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: ULTRALON (R) POWDER FREE LATEX SURGICAL GLOVES
ANSELL HEALTHCARE PRODUCTS, INC. 510(k) NO: K013604(SPECIAL)
ATTN: JAMES R CHATTERTON PHONE NO : 330-833-2811
1875 HARSH AVENUE, SE SE DECISION MADE: 13-NOV-01
MASSILLON, OH 44646 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APEX MODULAR ALUMINA FEMORAL HEAD
APEX SURGICAL, LLC. 510(k) NO: K012918(TRADITIONAL)
ATTN: EDWARD J CHEAL PHONE NO : 508-947-6500
12 HARDING STREET,SUITE 202 SE DECISION MADE: 27-NOV-01
LAKEVILLE, MA 02347 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURESET INFUSION SET, MODEL 8023
APPLIED DIABETES RESEARCH, INCORPO510(k) NO: K012429(TRADITIONAL)
ATTN: CHARLES H KYPER PHONE NO :
103 NOLEN LANE SE DECISION MADE: 06-NOV-01
CHAPEL HILL, NC 27516 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHROCARE ARTHRO WANDS, ENETEC EVAC PLASMA WAND
ARTHROCARE CORP. 510(k) NO: K013463(SPECIAL)
ATTN: BRUCE PROTHRO PHONE NO : 408-736-0224
595 NORTH PASTORIA AVE. SE DECISION MADE: 15-NOV-01
SUNNYVALE, CA 94085-2936 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESORBABLE SCREW ANCHOR
ARTHROTEK, INC. 510(k) NO: K012872(TRADITIONAL)
ATTN: SARA B SHULTZ PHONE NO : 219-267-6639
56 EAST BELLE DRIVE SE DECISION MADE: 20-NOV-01
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46582
DEVICE: ASTRA TECH IMPLANTS-DENTAL SYSTEM
ASTRA TECH, INC. 510(k) NO: K012965(TRADITIONAL)
ATTN: BRUCE R MANNING PHONE NO : 508-393-3100
96 WEST MAIN STREET SE DECISION MADE: 19-NOV-01
NORTHBOROUGH, MA 01532 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO BASIC DENTAL IMPLANT SYSTEM
BASIC DENTAL IMPLANT SYSTEMS, INC.510(k) NO: K013682(SPECIAL)
ATTN: DAN BLACKLOCK PHONE NO : 505-881-1376
3321 COLUMBIA, N.E. SE DECISION MADE: 28-NOV-01
ALBUQUERQUE, NM 87107-2001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RENU MULTIPLUS NO RUB MULTI-PURPOSE SOLUTION
BAUSCH & LOMB, INC. 510(k) NO: K011796(TRADITIONAL)
ATTN: PAUL G STAPLETON PHONE NO : 716-338-8172
1400 NORTH GOODMAN ST. SE DECISION MADE: 01-NOV-01
ROCHESTER, NY 14603 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DOCUMENTING LASER SLIT LAMP, DP 2010
BAUSCH & LOMB, INC. 510(k) NO: K012873(TRADITIONAL)
ATTN: PENNI L PANNELL PHONE NO : 949-454-4530
9342 JERONIMO RD. SE DECISION MADE: 19-NOV-01
IRVINE, CA 92718 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYBERCASES BY BAUSCH & LOMB
BAUSCH & LOMB, INC. 510(k) NO: K013232(TRADITIONAL)
ATTN: KIM S DEVITTO PHONE NO : 716-338-6401
1400 NORTH GOODMAN ST. SE DECISION MADE: 20-NOV-01
P.O. BOX 30450 510(k) SUMMARY AVAILABLE FROM FDA
ROCHESTER, NY 14603-0450
DEVICE: ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY
BAYER CORP. 510(k) NO: K011963(TRADITIONAL)
ATTN: KENNETH T EDDS PHONE NO : 914-524-2446
511 BENEDICT AVE. SE DECISION MADE: 20-NOV-01
TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGU
BECTON DICKINSON INFUSION THERAPY 510(k) NO: K013073(TRADITIONAL)
ATTN: LESLIE WOOD PHONE NO : 801-565-2504
9450 SOUTH STATE ST. SE DECISION MADE: 08-NOV-01
SANDY, UT 84070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ICE BATON
BEHIVE LTD 510(k) NO: K012746(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 14-NOV-01
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001
BENLAN, INC. 510(k) NO: K010607(TRADITIONAL)
ATTN: BILL LIM PHONE NO : 905 829 5004
2760 BRIGHTON RD. SE DECISION MADE: 28-NOV-01
OAKVILLE, ONTARIO, CANADA L6H 5T4 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST
BINAX, INC. 510(k) NO: K012521(TRADITIONAL)
ATTN: PAMELA ANGELL PHONE NO : 207-772-3988
217 READ ST. SE DECISION MADE: 30-NOV-01
PORTLAND, ME 04103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRIPMAX 1210 URINE CHEMISTRY ANALYZER, URIMATE REAGENT STRIP FO
BIOCARE CORP. 510(k) NO: K012829(TRADITIONAL)
ATTN: BRUCE A MACFARLAND PHONE NO : 952-646-3188
5182 WEST 76TH STREET SE DECISION MADE: 02-NOV-01
MINNEAPOLIS, MN 55439 510(k) STATEMENT
DEVICE: INTEX SCREW
BIOMET, INC. 510(k) NO: K012798(TRADITIONAL)
ATTN: DALENE T BINKLEY PHONE NO : 800-348-9500
P.O. BOX 587 SE DECISION MADE: 16-NOV-01
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH
BIONET COMPANY LTD 510(k) NO: K011328(TRADITIONAL)
ATTN: MIN SOO HAN PHONE NO : 822 346 83660
3F, DAEYANG BLDG., 999 SE DECISION MADE: 21-NOV-01
DAECHI-DONG, KANGNAM-GU 510(k) SUMMARY AVAILABLE FROM FDA
SEOUL, REPUBLIC OF KOREA
DEVICE: MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214
BIONX IMPLANTS, INC. 510(k) NO: K013546(SPECIAL)
ATTN: TUIJA ANNALA PHONE NO : 358 331 65600
HERMIANKATU 6-8 L SE DECISION MADE: 21-NOV-01
TAMPERE, FINLAND FIN-33720 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOPLATE RESORBABLE BONE SCREW
BIOPLATE, INC. 510(k) NO: K012908(TRADITIONAL)
ATTN: ERIC V HOHENSTEIN PHONE NO : 323-549-9500
6911 MELROSE AVE. SE DECISION MADE: 28-NOV-01
LOS ANGELES, CA 90038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE BIOPLATE MANDIBLE FIXATION SYSTEM
BIOPLATE, INC. 510(k) NO: K012910(TRADITIONAL)
ATTN: BRUCE F MACKLER PHONE NO : 202-912-2000
1666 K STREET NW SE DECISION MADE: 20-NOV-01
SUITE 200 510(k) STATEMENT
WASHINGTON, DC 20006-4004
DEVICE: CARTO XP EP NAVIGATION SYSTEM
BIOSENSE WEBSTER, INC. 510(k) NO: K013083(SPECIAL)
ATTN: AMY WALTERS PHONE NO : 909-839-8804
3333 DIAMOND CANYON RD. SE DECISION MADE: 21-NOV-01
DIAMOND BAR, CA 91765 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRA-THIN SDS BALLOON DILATATION CATHETER
BOSTON SCIENTIFIC CORP. 510(k) NO: K011909(TRADITIONAL)
ATTN: JENNIFER BOLTON PHONE NO : 508-652-5972
ONE BOSTON SCIENTIFIC PLACE SE DECISION MADE: 28-NOV-01
NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WALLSTENT RX BILIARY ENDOPROSTHESES, MODELS 6961-6972 INCLUSIVE
BOSTON SCIENTIFIC CORP. 510(k) NO: K012752(TRADITIONAL)
ATTN: KATHLEEN MORAHAN PHONE NO : 508-652-5942
ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 15-NOV-01
NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SCOOPER DRUG/ADULTERATION TEST CUP
BRANAN MEDICAL CORP. 510(k) NO: K013124(SPECIAL)
ATTN: RAPHAEL WONG PHONE NO : 949-598-7166
10015 MUIRLANDS RD., SUITE E SE DECISION MADE: 07-NOV-01
IRVINE, CA 92618 510(k) STATEMENT
DEVICE: MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS
CAMBRIDGE HEART, INC. 510(k) NO: K013564(SPECIAL)
ATTN: JOHN GREENBAUM PHONE NO : 954-680-2548
20310 SW 48TH ST. SE DECISION MADE: 21-NOV-01
FT. LAUDERDALE, FL 33332 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000
CAMBRIDGE HEART, INC. 510(k) NO: K013565(SPECIAL)
ATTN: JOHN GREENBAUM PHONE NO : 954-680-2548
20310 SW 48TH ST. SE DECISION MADE: 21-NOV-01
FT. LAUDERDALE, FL 33332 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWERHEART CARDIAC RHYTHM MODULE
CARDIAC SCIENCE, INC. 510(k) NO: K012197(TRADITIONAL)
ATTN: SEW-WAH TAY PHONE NO : 952-939-2942
5420 FELTL ROAD SE DECISION MADE: 16-NOV-01
MINNEAPOLIS, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITOR
CARDIODYNAMICS INTERNATIONAL CORP.510(k) NO: K011439(TRADITIONAL)
ATTN: BRIAN PARK PHONE NO : 858-535-0202
6175 NANCY RIDGE DR., #300 SE DECISION MADE: 02-NOV-01
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BERNOULLI VENTILATOR MANAGEMENT SYSTEM
CARDIOPULMONARY CORP. 510(k) NO: K011861(TRADITIONAL)
ATTN: JOHN LAVIOLA PHONE NO : 203-877-1999
200 CASCADE BLVD. SE DECISION MADE: 06-NOV-01
MILFORD, CT 06460 510(k) STATEMENT
DEVICE: VISULAS 532S
CARL ZEISS, INC. 510(k) NO: K013402(SPECIAL)
ATTN: KENNETH M NICOLL PHONE NO : 914-747-1800
ONE ZEISS DR. SE DECISION MADE: 14-NOV-01
THORNWOOD, NY 10594 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOTAL O2
CHAD THERAPEUTICS, INC. 510(k) NO: K013472(TRADITIONAL)
ATTN: KEVIN MCCULLOH PHONE NO : 818-882-0883
21622 PLUMMER ST. SE DECISION MADE: 28-NOV-01
CHATSWORTH, CA 91311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUR-8, MODELS DUR-8
CIRCON VIDEO 510(k) NO: K012925(TRADITIONAL)
ATTN: WAYNE STERNER PHONE NO : 805-685-5100
6500 HOLLISTER AVE. SE DECISION MADE: 07-NOV-01
SANTA BARBARA, CA 93117 510(k) STATEMENT
DEVICE: FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735
CIRCON VIDEO 510(k) NO: K012929(TRADITIONAL)
ATTN: WAYNE STERNER PHONE NO : 805-685-5100
6500 HOLLISTER AVE. SE DECISION MADE: 19-NOV-01
SANTA BARBARA, CA 93117 510(k) STATEMENT
DEVICE: APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPE
CIRCON VIDEO 510(k) NO: K012951(TRADITIONAL)
ATTN: WAYNE B STERNER PHONE NO : 805-685-5100
6500 HOLLISTER AVE. SE DECISION MADE: 09-NOV-01
SANTA BARBARA, CA 93117 510(k) STATEMENT
DEVICE: THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VE
CIRCULATORY TECHNOLOGY, INC. 510(k) NO: K012942(TRADITIONAL)
ATTN: YEHUDA TAMARI PHONE NO : 516-624-2424
21 SINGWORTH ST. SE DECISION MADE: 05-NOV-01
OYSTER BAY, NY 11771 510(k) STATEMENT
DEVICE: LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A=E FOR BECKMAN C
CLINIQA CORPORATION 510(k) NO: K013332(TRADITIONAL)
ATTN: CAROL RUGGIERO PHONE NO : 760-744-1900
1432-B SOUTH MISSION ROAD SE DECISION MADE: 20-NOV-01
FALLBROOK, CA 92028 510(k) STATEMENT
DEVICE: SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIO
COBE CARDIOVASCULAR, INC. 510(k) NO: K012763(ABBREVIATED)
ATTN: LYNNE LEONARD PHONE NO : 303-467-6586
14401 WEST 65TH WAY SE DECISION MADE: 15-NOV-01
ARVADA, CO 80004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGE
COBE CARDIOVASCULAR, INC. 510(k) NO: K013480(SPECIAL)
ATTN: SHAWN RIEDEL PHONE NO : 303-467-6521
14401 WEST 65TH WAY SE DECISION MADE: 16-NOV-01
ARVADA, CO 80004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FANELLI BILIARY STENT
COOK, INC. 510(k) NO: K010601(TRADITIONAL)
ATTN: LISA HOPKINS PHONE NO : 812-339-2235
925 SOUTH CURRY PIKE SE DECISION MADE: 16-NOV-01
P.O. BOX 489 510(k) SUMMARY AVAILABLE FROM FDA
BLOOMINGTON, IN 47402
DEVICE: SPECTRUM VENTRICULAR CATHETER
COOK, INC. 510(k) NO: K011812(TRADITIONAL)
ATTN: APRIL LAVENDER PHONE NO : 812-339-2235
925 SOUTH CURRY PIKE SE DECISION MADE: 08-NOV-01
P.O. BOX 489 510(k) SUMMARY AVAILABLE FROM FDA
BLOOMINGTON, IN 47402
DEVICE: CORDIS AVIATOR PERIPHERAL DILATATION CATHETER
CORDIS, A JOHNSON & JOHNSON CO. 510(k) NO: K013581(SPECIAL)
ATTN: CHUCK RYAN PHONE NO : 908-412-7446
7 POWDER HORN DRIVE SE DECISION MADE: 28-NOV-01
WARREN, NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEEP GRAY
CORTECHS LLC 510(k) NO: K012563(ABBREVIATED)
ATTN: JEFFREY M ANDERS PHONE NO : 617-241-9588
6 13TH ST. SE DECISION MADE: 02-NOV-01
CHARLESTOWN, MA 02129-2027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONO-DOX, SYNTHETIC ABSORBABLE POLYDIOXANONE SURGICAL SUTURE,STE
CP MEDICAL 510(k) NO: K013274(TRADITIONAL)
ATTN: MARY ANN GREENAWALT PHONE NO : 503-232-1555
836 N.E. 24TH AVE. SE DECISION MADE: 16-NOV-01
PORTLAND, OR 97232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYNOSURE PHOTOGENICA ER
CYNOSURE, INC. 510(k) NO: K012790(TRADITIONAL)
ATTN: GEORGE CHO PHONE NO : 978-256-4200
10 ELIZABETH DR. SE DECISION MADE: 16-NOV-01
CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYNOSURE PHOTOGENICA VL
CYNOSURE, INC. 510(k) NO: K012806(TRADITIONAL)
ATTN: GEORGE CHO PHONE NO : 978-256-4200
10 ELIZABETH DR. SE DECISION MADE: 19-NOV-01
CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION HAIC ASSAY, MODEL DF105
DADE BEHRING, INC. 510(k) NO: K011852(TRADITIONAL)
ATTN: CATHY CRAFT PHONE NO : 302-631-6280
GLASGOW BUSINESS COMMUNITY SE DECISION MADE: 15-NOV-01
P.O. BOX 6101, BUILDING 500 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714
DEVICE: BCS SYSTEM
DADE BEHRING, INC. 510(k) NO: K013114(TRADITIONAL)
ATTN: REBECCA S AYASH PHONE NO : 302-631-6276
GLASGOW SITE SE DECISION MADE: 09-NOV-01
P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714
DEVICE: N LP(A) STANDARD SY
DADE BEHRING, INC. 510(k) NO: K013126(TRADITIONAL)
ATTN: REBECCA S AYASH PHONE NO : 302-631-6276
GLASGOW SITE SE DECISION MADE: 09-NOV-01
P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714
DEVICE: NEUROMOVE NM900
DAN MED, INC. 510(k) NO: K012885(TRADITIONAL)
ATTN: THOMAS SANDGAARD PHONE NO : 800-495-6670
4 WEST DRY CREEK CIRCLE, SE DECISION MADE: 08-NOV-01
SUITE 260 510(k) STATEMENT
DENVER, CO 80120
DEVICE: MODIFICATION TO: DATASCOPE 8FR. POLYIMIDE ALT B IAB, 25CC, 34CC,
DATASCOPE CORP. 510(k) NO: K013326(SPECIAL)
ATTN: JOANN WOLF PHONE NO : 973-244-6123
15 LAW DR. SE DECISION MADE: 02-NOV-01
FAIRFIELD, NJ 07004-3206 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX
DATEX-OHMEDA 510(k) NO: K012531(TRADITIONAL)
ATTN: JOEL KENT PHONE NO : 781-449-8685
86 PILGRIM ROAD SE DECISION MADE: 02-NOV-01
NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NORAD, NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE
DENNIS R. BAILEY, DDS 510(k) NO: K013049(TRADITIONAL)
ATTN: DENNIS R BAILEY PHONE NO : 303-770-3300
7901 EAST BELLEVIEW AVENUE SE DECISION MADE: 29-NOV-01
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
ENGLEWOOD, CO 80111
DEVICE: TULSA CONTRA ANGLES
DENTSPLY INTL. 510(k) NO: K012720(TRADITIONAL)
ATTN: P. JEFFREY LEHN PHONE NO : 717-845-7511
570 WEST COLLEGE AVE SE DECISION MADE: 08-NOV-01
YORK, PA 17404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYMPHONY GRAFT DELIVERY SYSTEM (GDS)
DEPUY ACROMED 510(k) NO: K012738(TRADITIONAL)
ATTN: KAREN F JURCZAK PHONE NO : 508-828-3704
325 PARAMOUNT DR. SE DECISION MADE: 14-NOV-01
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISCOVERY FACET SCREW FIXATION SYSTEM
DEPUY ACROMED 510(k) NO: K012773(TRADITIONAL)
ATTN: KAREN F JURCZAK PHONE NO : 508-828-3704
325 PARAMOUNT DR. SE DECISION MADE: 16-NOV-01
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUMMIT OCCIPITO-CERVICO- THORACIC (OCT) SPINAL SYSTEM
DEPUY ACROMED 510(k) NO: K013222(TRADITIONAL)
ATTN: KAREN F JURCZAK PHONE NO : 508-828-3704
325 PARAMOUNT DR. SE DECISION MADE: 07-NOV-01
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: STACKABLE CAGE SYSTEM
DEPUY ACROMED 510(k) NO: K013382(SPECIAL)
ATTN: KAREN F JURCZAK PHONE NO : 508-828-3704
325 PARAMOUNT DR. SE DECISION MADE: 07-NOV-01
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISOLA POLYAXIAL WASHER
DEPUY ACROMED 510(k) NO: K013441(SPECIAL)
ATTN: LISA GILMAN PHONE NO : 508-828-8287
325 PARAMOUNT DR. SE DECISION MADE: 16-NOV-01
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FRONTIER ANTERIOR SCOLIOSIS SYSTEM
DEPUY ACROMED, INC. 510(k) NO: K012916(TRADITIONAL)
ATTN: LISA GILMAN PHONE NO : 508-880-8287
325 PARAMOUNT DR. SE DECISION MADE: 27-NOV-01
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BSM BONE SUBSTITUTE MATERIAL
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K011048(TRADITIONAL)
ATTN: LYNNETTE WHITAKER PHONE NO : 219-371-4903
700 ORTHOPAEDIC DR. SE DECISION MADE: 13-NOV-01
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: MODIFICATION TO DEPUY C-STEM SYSTEM
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K013350(SPECIAL)
ATTN: MARCIA J ARENTZ PHONE NO : 219-371-4944
700 ORTHOPAEDIC DR. SE DECISION MADE: 07-NOV-01
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: STERILE COLLES CLASSIC FIXATOR
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K013503(SPECIAL)
ATTN: MARCIA J ARENTZ PHONE NO : 219-371-4944
700 ORTHOPAEDIC DR. SE DECISION MADE: 16-NOV-01
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100
DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K013566(SPECIAL)
ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200
5700 WEST 96TH ST. SE DECISION MADE: 20-NOV-01
LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE
DIAMETRICS MEDICAL, INC. 510(k) NO: K011586(TRADITIONAL)
ATTN: NANCY RING PHONE NO : 651-639-8035
2658 PATTON RD. SE DECISION MADE: 16-NOV-01
ROSEVILLE, MN 55113 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIOMED 15 PLUS AND DIOMED 30PLUS LASERS
DIOMED, INC. 510(k) NO: K013499(SPECIAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 16-NOV-01
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISETRONIC PENFINE INSULIN INJECTION PEN NEEDLE
DISETRONIC MEDICAL SYSTEMS 510(k) NO: K013782(TRADITIONAL)
ATTN: DAVID E CHADWICK PHONE NO : 763-795-5200
5151 PROGRAM AVENUE SE DECISION MADE: 20-NOV-01
ST. PAUL, MN 55112-1014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DORNIER SAPPHIREERBIUM HANDPIECE, DORNIER SAPPHIRESPOT HANDPIECE
DORNIER MEDICAL SYSTEMS, INC. 510(k) NO: K011322(TRADITIONAL)
ATTN: BRIAN WALSH PHONE NO : 770-514-6204
1155 ROBERTS BLVD. SE DECISION MADE: 19-NOV-01
KENNESAW, GA 30144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B
DYNAREX CORP. 510(k) NO: K012917(TRADITIONAL)
ATTN: JOHN GAGLIARDI PHONE NO : 513-573-0085
7736 WOODSIDE COURT SE DECISION MADE: 28-NOV-01
MAINEVILLE, OH 45039 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBI SPINELINK - II SPINAL FIXATION SYSTEM
EBI, L.P. 510(k) NO: K012516(TRADITIONAL)
ATTN: PATRICIA M FLOOD PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 27-NOV-01
PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBI XFIX DFS SYSTEM
EBI, L.P. 510(k) NO: K013378(SPECIAL)
ATTN: MICHAEL T TAGGART PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 08-NOV-01
PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBI XFIX ACCESS PELVIC FIXATOR
EBI, L.P. 510(k) NO: K013540(SPECIAL)
ATTN: MICHAEL TAGGART PHONE NO : 973-299-9022
100 INTERPACE PKWY. SE DECISION MADE: 20-NOV-01
PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EFILM VIDEO
EFILM MEDICAL, INC. 510(k) NO: K013631(TRADITIONAL)
ATTN: JOSEPH A THOMAS PHONE NO : 416 204 9664
500 UNIVERSITY AVE., SUITE 300 SE DECISION MADE: 20-NOV-01
TORONTO, ONTARIO, CANADA M5G 1V7 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS
ELAN HOLDINGS, INC. 510(k) NO: K013152(TRADITIONAL)
ATTN: WYNN STOCKING PHONE NO : 714-672-3553
1075 W. LAMBERT RD., SUITE D SE DECISION MADE: 09-NOV-01
BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGITRON 120 IEC (ALSO KNOWN AS SURGITRON 4.0 DUAL RF
ELLMAN INTL., INC. 510(k) NO: K013255(TRADITIONAL)
ATTN: FRANK LIN PHONE NO : 516-569-1482
1135 RAILROAD AVE., SE DECISION MADE: 07-NOV-01
ELLMAN BLDG. 510(k) SUMMARY AVAILABLE FROM FDA
HEWLETT, NY 11557
DEVICE: PASS SPINAL SYSTEM
ENCORE ORTHOPEDICS, INC. 510(k) NO: K013431(SPECIAL)
ATTN: JOANNA DROEGE PHONE NO : 512-832-9500
9800 METRIC BLVD. SE DECISION MADE: 15-NOV-01
AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRI-FIX SPINAL FIXATION SYSTEM
ENDIUS, INC. 510(k) NO: K013403(SPECIAL)
ATTN: SUSAN FINNERAN PHONE NO : 508-643-0983
23 WEST BACON ST. SE DECISION MADE: 14-NOV-01
PLAINVILLE, MA 02762 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TISSUE GRASPING FORCEPS, SCISSORS, CLAMPS AND DISSECTORS FOR LAP
ENDO-THERAPEUTICS, INC. 510(k) NO: K012725(TRADITIONAL)
ATTN: TODD ADKISSON PHONE NO : 727-726-2446
1183 CEDAR ST. SE DECISION MADE: 08-NOV-01
SAFETY HARBOR, FL 34695-2908 510(k) STATEMENT
DEVICE: VARICES INJECTION NEEDLE
ENDO-THERAPEUTICS, INC. 510(k) NO: K012977(TRADITIONAL)
ATTN: TODD ADKISSON PHONE NO : 727-726-2446
1183 CEDAR ST. SE DECISION MADE: 02-NOV-01
SAFETY HARBOR, FL 34695-2908 510(k) STATEMENT
DEVICE: OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS)
ENGINEERED MEDICAL TECHNOLOGY, INC510(k) NO: K001121(ABBREVIATED)
ATTN: DON SCHMIELEY PHONE NO : 361-578-3551
7303 HOUSTON HWY. SE DECISION MADE: 29-NOV-01
P.O. BOX 1939 510(k) SUMMARY AVAILABLE FROM FDA
VICTORIA, TX 77902
DEVICE: MOLDED CRANIAL HELMET
FAIRVIEW ORTHOPEDIC LABORATORY 510(k) NO: K012920(TRADITIONAL)
ATTN: ROSS C D'EMANUELE PHONE NO : 612-343-2161
220 S.6TH STREET SE DECISION MADE: 28-NOV-01
MINNEAPOLIS, MN 55402-1498 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PARADIGM-FONTONA PEROVSKITE ND: YAP LASER SYSTEM AND ACCESSORIES
FOTONA D.D. 510(k) NO: K011174(TRADITIONAL)
ATTN: MOJCA VALJAVEC PHONE NO : 386 151 11215
STEGNE 7, SE DECISION MADE: 07-NOV-01
1210 LJUBLJANA, SLOVENIA 1210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIACLEAR ULTRAFILTER
GAMBRO RENAL PRODUCTS 510(k) NO: K003957(TRADITIONAL)
ATTN: SUZANNE DENNIS PHONE NO : 303-542-5075
10810 W. COLLINS AVE. SE DECISION MADE: 01-NOV-01
LAKEWOOD, CO 80215 510(k) STATEMENT
DEVICE: SIGNA OPENSPEED MAGNETIC RESONANCE SYSTEM
GE MEDICAL SYSTEM 510(k) NO: K012875(TRADITIONAL)
ATTN: LARRY KROGER PHONE NO : 262-544-3894
3200 N. GRANDVIEW BLVD. SE DECISION MADE: 20-NOV-01
WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIGHTSPEED 4.0 CT SCANNER SYSTEM
GE MEDICAL SYSTEM 510(k) NO: K013561(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894
16800 RYERSON ROAD SE DECISION MADE: 08-NOV-01
NEW BERLIN, WI 53151 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DUAL ENERGY AND TISSUE EQUALIZATION SOFTWARE OPTION
GE MEDICAL SYSTEMS 510(k) NO: K013481(TRADITIONAL)
ATTN: JODI PARKER PHONE NO : 262-548-4964
3000 NORTH GRANDVIEW BLVD. SE DECISION MADE: 02-NOV-01
WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORIN
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K012718(TRADITIONAL)
ATTN: JOELLE NEIDER PHONE NO : 203-949-8232
61 BARNES PARK RD., NORTH SE DECISION MADE: 13-NOV-01
WALLINGFORD, CT 06492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GIMMI ALPHA SINUSCOPES MODEL # E.8282.01/31/71 + E.8284.01/31/71
GIMMI GMBH 510(k) NO: K013731(TRADITIONAL)
ATTN: DAGMAR S MASER PHONE NO : 312 042 89591
AMSTEL 320-I SE DECISION MADE: 27-NOV-01
AMSTERDAM, NETHERLANDS 1017AP 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANEURYSM CLIPS
GISTLSTRASSE 510(k) NO: K013136(TRADITIONAL)
ATTN: DIETER VON SEPPELIN PHONE NO : 498 979 36880
GISTLSTRASSE 99 SE DECISION MADE: 26-NOV-01
PULLACH, GERMANY 82049 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FAS SET #4551
GYNETICS MEDICAL PRODUCTS NV 510(k) NO: K013497(TRADITIONAL)
ATTN: GRACE HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 09-NOV-01
IRVINE, CA 92606 510(k) STATEMENT
DEVICE: IUI, MODEL 4220; SMOOZE, MODEL 4225, L; SEMINOR, MODEL 4502 A, B
GYNETICS MEDICAL PRODUCTS NV 510(k) NO: K013501(TRADITIONAL)
ATTN: GRACE HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 30-NOV-01
IRVINE, CA 92606 510(k) STATEMENT
DEVICE: EMTRAC; DELPHIN; SEMTRAC 2000 SET
GYNETICS MEDICAL PRODUCTS NV 510(k) NO: K013536(TRADITIONAL)
ATTN: GRACE HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 30-NOV-01
IRVINE, CA 92606 510(k) STATEMENT
DEVICE: TWINTRODE ELC 134 ELECTRODE
HEALTH TRONICS SURGICAL SERVICES, 510(k) NO: K012785(TRADITIONAL)
ATTN: PETER WEIMAN PHONE NO : 770-419-0691
1841 WEST OAK PARKWAY, SUITE A SE DECISION MADE: 16-NOV-01
MARIETTA, GA 30062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257
HEINZ KURZ GMBH MEDIZINTECHNIK 510(k) NO: K013573(SPECIAL)
ATTN: DAGMAR S MASER PHONE NO : 312 042 89591
AMSTEL 320-I SE DECISION MADE: 09-NOV-01
AMSTERDAM, NETHERLANDS 1017 AP 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HILL-ROM PRIMAVIEW MONITOR SYSTEM
HILL-ROM, INC. 510(k) NO: K013709(TRADITIONAL)
ATTN: TIMOTHY M DAVIS PHONE NO : 800-445-2114
1069 STATE RT. 46 EAST SE DECISION MADE: 16-NOV-01
BATESVILLE, IN 47006 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ICONNECTION 3D
HINNOVATION, INC. 510(k) NO: K012779(TRADITIONAL)
ATTN: YI ISABELLE SUN PHONE NO : 414-453-7881
10437 INNOVATION DRIVE SE DECISION MADE: 02-NOV-01
SUITE 236 510(k) SUMMARY AVAILABLE FROM FDA
WAUWATOSA, WI 53226-4815
DEVICE: DURACON CONSTRAINED POSTERIOR STABILIZED (PS) TIBIAL INSERT
HOWMEDICA OSTEONICS CORP. 510(k) NO: K012776(TRADITIONAL)
ATTN: MARGARET F CROWE PHONE NO : 201-934-4359
59 ROUTE 17 SE DECISION MADE: 16-NOV-01
ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LONG LENGTH DYAX NAIL
HOWMEDICA OSTEONICS CORP. 510(k) NO: K013468(SPECIAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-760-8187
59 ROUTE 17 SE DECISION MADE: 16-NOV-01
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TROCHANTERIC DYAX NAIL SYSTEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K013524(SPECIAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-760-8187
59 ROUTE 17 SE DECISION MADE: 14-NOV-01
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODE
IMMUNO CONCEPTS, INC. 510(k) NO: K013283(TRADITIONAL)
ATTN: ERIC S HOY PHONE NO : 972-247-3616
2280 SPRINGLAKE ROAD SE DECISION MADE: 14-NOV-01
SUITE 106 510(k) SUMMARY AVAILABLE FROM FDA
DALLAS, TX 75234
DEVICE: RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, M
IMMUNO CONCEPTS, INC. 510(k) NO: K013285(TRADITIONAL)
ATTN: ERIC S HOY PHONE NO : 972-247-3616
2280 SPRINGLAKE ROAD SE DECISION MADE: 14-NOV-01
SUITE 106 510(k) SUMMARY AVAILABLE FROM FDA
DALLAS, TX 75234
DEVICE: IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G
IMMUNO CONCEPTS, INC. 510(k) NO: K013432(TRADITIONAL)
ATTN: ERIC S HOY PHONE NO : 916-363-2649
9779 BUSINESS PARK DR. SE DECISION MADE: 29-NOV-01
SUITE D 510(k) SUMMARY AVAILABLE FROM FDA
SACRAMENTO, CA 95827
DEVICE: QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00
IMPAC MEDICAL SYSTEMS, INC. 510(k) NO: K013531(TRADITIONAL)
ATTN: THOMAS H FARIS PHONE NO : 650-623-8807
100 WEST EVELYN AVE. SE DECISION MADE: 07-NOV-01
MOUNTAIN VIEW, CA 94041 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ULTRA THICK MALE LATEX CONDOM WITH SILICONE LUBRICANT
INNOLATEX SDN. BHD 510(k) NO: K012664(TRADITIONAL)
ATTN: CHANG AH-KAU PHONE NO : 603 747 2434
NO 16, JALAN BULAN U5/5 SE DECISION MADE: 09-NOV-01
BANDAR PINGGIRAN SUBANG, 510(k) STATEMENT
SHAH ALAM,SELANGOR DARUL EHSAN, MALAYSIA
DEVICE: ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANT
INNOLATEX SDN. BHD 510(k) NO: K012665(TRADITIONAL)
ATTN: CHANG AH-KAU PHONE NO : 603 747 2434
NO 16, JALAN BULAN U5/5 SE DECISION MADE: 09-NOV-01
BANDAR PINGGIRAN SUBANG, 510(k) STATEMENT
SHAH ALAM,SELANGOR DARUL EHSAN, MALAYSIA
DEVICE: DOTTED CONDOM, MALE NATURAL RUBBER LATEX CONDOM
INNOLATEX SDN. BHD 510(k) NO: K012962(ABBREVIATED)
ATTN: CHANG AH-KAU PHONE NO : 603 747 2434
NO 16, JALAN BULAN U5/5 SE DECISION MADE: 09-NOV-01
BANDAR PINGGIRAN SUBANG, 510(k) STATEMENT
SHAH ALAM,SELANGOR DARUL EHSAN, MALAYSIA
DEVICE: 56MM CONDOM,MALE NATURAL RUBBER LATEX CONDOM
INNOLATEX SDN. BHD 510(k) NO: K012964(ABBREVIATED)
ATTN: CHANG AH-KAU PHONE NO : 603 747 2434
NO. 16, JALAN BULAN U5/5, SE DECISION MADE: 09-NOV-01
BANDAR PINGGIRAN SUBANG 510(k) STATEMENT
SHAH ALAM, SELANGOR D.E., MALAYSIA 40150
DEVICE: IQUANTIFY, VERSION 1.0
INSIGTHFUL CORP. 510(k) NO: K011196(TRADITIONAL)
ATTN: BRADLEY T WYMAN PHONE NO : 206-283-8802
1700 WESTLAKE AVE. SE DECISION MADE: 08-NOV-01
SUITE 500 510(k) SUMMARY AVAILABLE FROM FDA
SEATTLE, WA 98109-3044
DEVICE: TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL, MODEL 811
INTERPORE CROSS INTL. 510(k) NO: K010989(TRADITIONAL)
ATTN: LYNN R RODARTI PHONE NO : 949-453-3200
181 TECHNOLOGY DR. SE DECISION MADE: 07-NOV-01
IRVINE, CA 92618-2402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTUITIVE SURGICAL BIPOLAR FORCEPS
INTUITIVE SURGICAL, INC. 510(k) NO: K012833(TRADITIONAL)
ATTN: MICHAEL YRAMATEGUI PHONE NO : 659-237-7000
1340 WEST MIDDLEFIELD RD. SE DECISION MADE: 16-NOV-01
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE
INVERNESS MEDICAL TECHNOLOGY, INC.510(k) NO: K011479(TRADITIONAL)
ATTN: CAROL A ADILETTO PHONE NO : 781-647-3900
51 SAWYER ROAD SE DECISION MADE: 30-NOV-01
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
WALTHAM, MA 02453-3448
DEVICE: WATCH-PAT 100
ITAMAR MEDICAL (C.M.) 1997 LTD. 510(k) NO: K010739(TRADITIONAL)
ATTN: GEORGE MYERS PHONE NO : 201-727-1703
377 ROUTE 17 SE DECISION MADE: 06-NOV-01
HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HIGH GOLD PALLADIUM FREE CERAMIC SOLDER
IVOCLAR USA, INC. 510(k) NO: K012877(TRADITIONAL)
ATTN: ANDERJEET GULATI PHONE NO : 800-533-6825
175 PINEVIEW DR. SE DECISION MADE: 21-NOV-01
AMHERST, NY 14150 510(k) STATEMENT
DEVICE: JOSTRA ARTERIAL PERFUSION CANNULAE, MODEL A...
JOSTRA AG 510(k) NO: K012617(TRADITIONAL)
ATTN: KATHLEEN JOHNSON PHONE NO : 610-932-7738
P.O. BOX 218 SE DECISION MADE: 06-NOV-01
OXFORD, PA 19363 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JOSTRA ARTERIAL PERFUSION CANNULAE
JOSTRA AG 510(k) NO: K012774(TRADITIONAL)
ATTN: KATHLEEN JOHNSON PHONE NO : 610-932-7738
478 MEDIA ROAD SE DECISION MADE: 16-NOV-01
OXFORD, PA 19363 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KADANCE 2000
KADA RESEARCH, INC. 510(k) NO: K012492(TRADITIONAL)
ATTN: HARVEY KNAUSS PHONE NO : 713-723-4080
11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 02-NOV-01
HOUSTON, TX 77071-3404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KSEA SIALOENDOSCOPES AND ACCESSORIES
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K012527(TRADITIONAL)
ATTN: JAMES A LEE PHONE NO : 310-410-2769
600 CORPORATE POINTE SE DECISION MADE: 01-NOV-01
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAFESKIN HEALTHTOUCH POWDER-FREE EXAM GLOVE WITH VITAMIN E AND A
KIMBERLY-CLARK CORP. 510(k) NO: K012815(TRADITIONAL)
ATTN: MARCIA JOHNSON PHONE NO : 770-587-8324
1400 HOLCOMB BRIDGE RD. SE DECISION MADE: 13-NOV-01
ROSWELL, GA 30076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STARS2000 POWER CANNULA
KMI KOLSTER METHODS, INC. 510(k) NO: K012236(TRADITIONAL)
ATTN: ALWIN H KOLSTER PHONE NO : 714-956-1964
1170 N. GILBERT ST. SE DECISION MADE: 19-NOV-01
ANAHEIM, CA 92801 510(k) STATEMENT
DEVICE: LERMAN & SON CRANIAL ORTHOSIS HELMET
LERMAN & SON 510(k) NO: K012830(TRADITIONAL)
ATTN: MAX LERMAN PHONE NO : 310-659-2290
8710 WILSHIRE BLVD. SE DECISION MADE: 20-NOV-01
BEVERLY HILLS, CA 90211 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESECTION ABLATOR
LINVATEC CORP. 510(k) NO: K013117(TRADITIONAL)
ATTN: LAURA D SENEFF PHONE NO : 727-399-5234
11311 CONCEPT BOULEVARD SE DECISION MADE: 29-NOV-01
LARGO, FL 34643 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARAMIS DERMATLOGIC LASER
LUMEDICS, LTD. 510(k) NO: K012545(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEEN STREET N.W. SE DECISION MADE: 05-NOV-01
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VALIDATE CHEM 6 CALIBRATION VERIFICATION TEST SET MODEL # 10006
MAINE STANDARDS CO. 510(k) NO: K013119(TRADITIONAL)
ATTN: CHRISTINE BEACH PHONE NO : 207-892-1300
765 ROOSEVELT TRAIL SE DECISION MADE: 16-NOV-01
WINDHAM, ME 04062-5365 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VALIDATE CHEM 7 CALIBRATION VERIFICATION TEST SET, MODEL 10007
MAINE STANDARDS CO. 510(k) NO: K013265(TRADITIONAL)
ATTN: CHRISTINE BEACH PHONE NO : 207-892-1300
765 ROOSEVELT TRAIL SE DECISION MADE: 20-NOV-01
WINDHAM, ME 04062-5365 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAROSIS PACS
MAROTECH, INC 510(k) NO: K012844(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 940-440-9530
2001 EAST OAKSHORES DRIVE SE DECISION MADE: 08-NOV-01
CROSSROADS, TX 76227 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERED LATEX MEDICAL MEDICAL EXAMINATION GLOVES WITH 150 MICRO
MAXTER GLOVE MANUFACTURING SDN BHD510(k) NO: K013443(TRADITIONAL)
ATTN: STANLEY THAI PHONE NO : 001 301 4438913
LOT 607, JALAN HAJI ABDUL SE DECISION MADE: 29-NOV-01
MANAN 510(k) SUMMARY AVAILABLE FROM FDA
41050 KLANG, SELANGOR, MALAYSIA 41050
DEVICE: COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETI
MED GEN, INC. 510(k) NO: K013239(TRADITIONAL)
ATTN: THEODORE BARASH PHONE NO : 561-740-1100
7284 W. PALMETTO PK. RD. SE DECISION MADE: 20-NOV-01
BOCA RATON, FL 33433-3406 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED ARTHROSCOPIC BLADES, ARTHROSCOPIC SHAVERS, SHAVER BL
MEDICAL INSTRUMENTS TECHNOLOGY, IN510(k) NO: K012624(TRADITIONAL)
ATTN: JACK SPEER PHONE NO : 435-674-4010
385 NORTH 3050 EAST, SUITE B SE DECISION MADE: 08-NOV-01
ST. GEORGE, UT 84790 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONOACE SA-8000 DIAGNOSTIC ULTRASOUND SYSTEM
MEDISON AMERICA, INC. 510(k) NO: K013627(TRADITIONAL)
ATTN: A. ROBERT DEPALMA PHONE NO : 714-889-3000
11075 KNOTT AVE. SE DECISION MADE: 16-NOV-01
CYPRESS, CA 90630-5135 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: POWER DRIVE
MEDITEAM AB 510(k) NO: K012944(TRADITIONAL)
ATTN: THOMAS STJERNKVIST PHONE NO : 46 31 3369103
GOTEBORGSVAGEN 74, SE DECISION MADE: 20-NOV-01
SAVEDALEN, SWEDEN S-433 63 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDSTAR 150
MEDNET SERVICES, INC. 510(k) NO: K013081(TRADITIONAL)
ATTN: DAVID L MATHEWS PHONE NO : 612-788-6228
2855 ANTHONY LN. SOUTH, #B10 SE DECISION MADE: 20-NOV-01
ST. ANTHONY, MN 55418 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDSTAR 100 INTERFERENTIAL STIMLATOR
MEDNET SERVICES, INC. 510(k) NO: K013082(TRADITIONAL)
ATTN: DAVID L MATHEWS PHONE NO : 612-788-6228
2855 ANTHONY LN. SOUTH, #B10 SE DECISION MADE: 16-NOV-01
ST. ANTHONY, MN 55418 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STENT SUPPORT GUIDE CATHETER
MEDTRONIC, INC. 510(k) NO: K010579(TRADITIONAL)
ATTN: FRED L BOUCHER PHONE NO : 978-777-0042
37A CHERRY HILL DRIVE SE DECISION MADE: 21-NOV-01
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GIOTTO IMAGE
MEDX, INC. 510(k) NO: K012953(TRADITIONAL)
ATTN: FLOYD R ROWAN PHONE NO : 847-463-2020
3456 N. RIDGE AVE., #100 SE DECISION MADE: 30-NOV-01
ARLINGTON HEIGHTS, IL 60004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LYMPHA PRESS PLUS DEVICE
MEGO AFEK 510(k) NO: K013331(TRADITIONAL)
ATTN: AHAVA STEIN PHONE NO : 972 976 70002
BEIT HAPA'AMON (BOX 124) SE DECISION MADE: 30-NOV-01
20 HATA'AS ST. 510(k) SUMMARY AVAILABLE FROM FDA
KFAR SABA, ISRAEL 44425
DEVICE: MICRO STAMPING LIGATING CLIP
MICRO STAMPING CORP. 510(k) NO: K013264(TRADITIONAL)
ATTN: JOHN GAGLIARDI PHONE NO : 513-573-0085
7736 WOODSIDE COURT SE DECISION MADE: 29-NOV-01
MAINEVILLE, OH 45039 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERIOLASE ND:YAG DENTAL LASER SYSTEM
MILLENNIUM DENTAL TECHNOLOGIES, IN510(k) NO: K010771(TRADITIONAL)
ATTN: DAVID M HARRIS PHONE NO : 510-583-7574
4256 HEYER AVENUE SE DECISION MADE: 27-NOV-01
CASTRO VALLEY, CA 94546 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE STORAGE CAP
MOLDED PRODUCTS 510(k) NO: K010366(ABBREVIATED)
ATTN: ELISE JOHNSTON PHONE NO :
P.O. BOX 15 SE DECISION MADE: 28-NOV-01
HARLAN, IA 51537 510(k) STATEMENT
DEVICE: DRT4 LASER DOPPLER PERFUSION AND TEMPERATURE MONITOR
MOOR INSTRUMENTS LTD. 510(k) NO: K011070(TRADITIONAL)
ATTN: DAVID BOGGETT PHONE NO : 440 129 735715
MILLWEY SE DECISION MADE: 07-NOV-01
AXMINSTER, DEVON, UNITED KINGDOM E510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HRH-127-ALLEGRA HEAD ARRAY COIL
MRI DEVICES CORP. 510(k) NO: K013508(SPECIAL)
ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402
1515 PARAMOUNT DR. SUITE A SE DECISION MADE: 20-NOV-01
WAUKESHA, WI 53186 510(k) STATEMENT
DEVICE: HNC-63-INT NEUROVASCULAR ARRAY COIL
MRI DEVICES CORP. 510(k) NO: K013602(SPECIAL)
ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402
1515 PARAMOUNT DR. SUITE A SE DECISION MADE: 20-NOV-01
WAUKESHA, WI 53186 510(k) STATEMENT
DEVICE: MODEL NT-360 RANGE OF MOTION
MYOTRONICS-NOROMED, INC. 510(k) NO: K013357(SPECIAL)
ATTN: FRAY ADIB PHONE NO : 800-426-0316
15425 53RD AVE. SOUTH SE DECISION MADE: 08-NOV-01
TUKWILA, WA 98188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL MES-9000/EMG SYSTEM
MYOTRONICS-NOROMED, INC. 510(k) NO: K013399(SPECIAL)
ATTN: FRAY ADIB PHONE NO : 206-243-4214
15425 53RD AVE. SOUTH SE DECISION MADE: 13-NOV-01
TUKWILA, WA 98188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: N2000 BASE STATION, N2001 NURSE STATION
NEPTEC DESIGN GROUP, LTD. 510(k) NO: K012801(TRADITIONAL)
ATTN: CHARLES H KYPER PHONE NO : 919-960-0049
103 NOLEN LANE SE DECISION MADE: 14-NOV-01
CHAPEL HILL, NC 27516 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO HANDMASTER
NESS-NEUROMUSCULAR ELECTRICAL STIM510(k) NO: K012823(TRADITIONAL)
ATTN: JONATHAN S HAHAN PHONE NO : 202-637-5794
555 13TH STREET, N.W. SE DECISION MADE: 14-NOV-01
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3CC NMT SAFETY SYRINGE
NEW MEDICAL TECHNOLOGY LTD. 510(k) NO: K010819(TRADITIONAL)
ATTN: MIKE MALANDRAKIS PHONE NO : 317-773-9560
1500 WEST OAK STREET SE DECISION MADE: 08-NOV-01
PO BOX 317 510(k) SUMMARY AVAILABLE FROM FDA
ZIONSVILLE, IN 46077
DEVICE: INFUSION IV SET
NIRVI INTL. USA 510(k) NO: K001879(TRADITIONAL)
ATTN: DARSHANA HATHI PHONE NO : 412-854-5531
467 DIABLO DR. SE DECISION MADE: 20-NOV-01
PITTSBURG, PA 15241 510(k) STATEMENT
DEVICE: NORDIX INC RECHARGEABLE BATTERY PART NUMBER 2116
NORDIX, INC. 510(k) NO: K013133(TRADITIONAL)
ATTN: MARIAN LISAK PHONE NO : 602-544-1690
6831 NORTH 21ST AVE. SE DECISION MADE: 13-NOV-01
PHOENIX, AZ 85015 510(k) STATEMENT
DEVICE: TCM ENDO III
NOUVAG AG 510(k) NO: K013185(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE SE DECISION MADE: 28-NOV-01
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BODY FAT ANALYZER, MODEL HBF-306
OMRON HEALTHCARE, INC. 510(k) NO: K011652(TRADITIONAL)
ATTN: OSAMU SHIRASAKI PHONE NO : 847-680-6200
300 LAKEVIEW PKWY. SE DECISION MADE: 07-NOV-01
VERNON HILLS, IL 60061 510(k) STATEMENT
DEVICE: MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE
ORIDION MEDICAL 1987 LTD. 510(k) NO: K011536(SPECIAL)
ATTN: SANFORD BROWN PHONE NO : 972 2 5899115
7 HAMARPE ST. P.O. BOX 45025 SE DECISION MADE: 14-NOV-01
HAR HOTZVIM INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
JERUSALEM, ISRAEL 91450
DEVICE: MODIFICATION TO: MAC-LINE O2/CO2 ORAL NASAL CANNULA SAMPLE LINE
ORIDION MEDICAL 1987 LTD. 510(k) NO: K013845(SPECIAL)
ATTN: SANFORD BROWN PHONE NO : 972 258 99115
7 HAMARPE ST. P.O. BOX 45025 SE DECISION MADE: 29-NOV-01
HAR HOTZVIM INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
JERUSALEM, ISRAEL 91450
DEVICE: HEALOS BONE GRAFT MATERIAL
ORQUEST, INC. 510(k) NO: K012751(TRADITIONAL)
ATTN: KRISTINE F LAHMAN PHONE NO : 650-237-4852
365 RAVENDALE DRIVE SE DECISION MADE: 14-NOV-01
MOUNTAIN VIEW, CA 94043-5712 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER & DIGITAL DOLPHIN
OSI MEDICAL, INC. 510(k) NO: K012626(TRADITIONAL)
ATTN: JON WERNER PHONE NO : 813-818-7488
13801 MCCORMICK DRIVE SE DECISION MADE: 02-NOV-01
TAMPA, FL 33626 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OM
OSMETECH 510(k) NO: K011043(TRADITIONAL)
ATTN: JOHN PLANT PHONE NO : 441 270 216444
ELECTRA HOUSE ELECTRA WAY SE DECISION MADE: 30-NOV-01
CREWE, UNITED KINGDOM CW1 6WZ 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTOJECT 2
OWEN MUMFORD USA, INC. 510(k) NO: K013362(TRADITIONAL)
ATTN: ROBERT SHAW PHONE NO : 770-425-5138
1755-A WEST OAK COMMONS CT. SE DECISION MADE: 13-NOV-01
MARIETTA, GA 30062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTISTIM
PAJUNK GMBH 510(k) NO: K011308(TRADITIONAL)
ATTN: LYNETTE HOWARD PHONE NO : 908-788-4580
203 MAIN STREET, PMB 166 SE DECISION MADE: 29-NOV-01
FLEMINGTON,, NJ 08822 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TROCAR SLEEVE AND ACCESSORIES, MODELS 1287-XX-XX
PAJUNK GMBH 510(k) NO: K012771(TRADITIONAL)
ATTN: MARTIN HANGER PHONE NO : 497 704 92910
AM HOLZPLATZ 5-7 SE DECISION MADE: 14-NOV-01
GEISINGEN, GERMANY D-78187 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: LIVESURE METHADONE SCREEN TESTS
PAN PROBE BIOTECH, INC. 510(k) NO: K013796(TRADITIONAL)
ATTN: ALICE H YU PHONE NO : 858-689-9936
8515 ARJONS DR., SUITE A SE DECISION MADE: 26-NOV-01
SAN DIEGO, CA 92126 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: TONOPORT V
PAR MEDIZINTECHNIK GMBH 510(k) NO: K012647(ABBREVIATED)
ATTN: LOTHAR ENGEL PHONE NO : 493 023 50700
EINEMSTRASSE 9 SE DECISION MADE: 09-NOV-01
BERLIN, GERMANY D-10787 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KP + LFM
PDS HEALTHCARE PRODUCTS, INC. 510(k) NO: K013489(TRADITIONAL)
ATTN: JIM LEWIS PHONE NO : 303-666-6340
908 MAIN ST. SE DECISION MADE: 29-NOV-01
LOUISVILLE, CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PF 5050 PRESSURE UNIT, MODEL PF 5050
PERIMED AB 510(k) NO: K011899(TRADITIONAL)
ATTN: BJORN BAKKEN PHONE NO : 011 468 58011990
DATAVAGEN 9-A SE DECISION MADE: 06-NOV-01
JARFALLA, SWEDEN S-175 26 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHILIPS COMPONENT COMPACT MONITOR,MODEL M1275B, PHILIPS COMPENEN
PHILIPS MEDICAL SYSTEMS, INC. 510(k) NO: K013199(SPECIAL)
ATTN: DAVE OSBORN PHONE NO : 978-659-3178
3000 MINUTEMAN RD. SE DECISION MADE: 28-NOV-01
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO:PHILIPS M3000A/M3046A COMPACT PORTABLE PATIENT M
PHILIPS MEDICAL SYSTEMS, INC. 510(k) NO: K013427(SPECIAL)
ATTN: DAVE OSBORN PHONE NO : 978-659-3178
3000 MINUTEMAN RD. SE DECISION MADE: 29-NOV-01
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO M2376A DEVICELINK SYSTEM
PHILIPS MEDICAL SYSTEMS, INC. 510(k) NO: K013470(SPECIAL)
ATTN: MIKE HUDON PHONE NO : 978-659-3173
3000 MINUTEMAN RD. SE DECISION MADE: 14-NOV-01
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CAL
PHOENIX DIAGNOSTICS, INC. 510(k) NO: K012987(TRADITIONAL)
ATTN: RAM NUNNA PHONE NO : 508-655-8310
8 TECH CIRCLE SE DECISION MADE: 07-NOV-01
NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIPPY, MODEL I88WA
PILLAR TECHNOLOGY, INC. 510(k) NO: K012846(TRADITIONAL)
ATTN: CHRIS TINSLEY PHONE NO : 620-325-2629
1101 ILLINOIS SE DECISION MADE: 20-NOV-01
P.O. BOX 187 510(k) STATEMENT
NEODESHA, KS 66757
DEVICE: HD/HDT, PV/PVT (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLE
POLY VUE TECHNOLGIES, INC. 510(k) NO: K013220(TRADITIONAL)
ATTN: MARTIN DALSING PHONE NO : 970-243-5490
623 GLACIER DR. SE DECISION MADE: 20-NOV-01
GRAND JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOSCANNER 2000
POLYMER TECHNOLOGY SYSTEMS, INC. 510(k) NO: K013068(TRADITIONAL)
ATTN: MARGO ENRIGHT PHONE NO : 317-870-5610
7736 ZIONSVILLE RD. SE DECISION MADE: 20-NOV-01
INDIANAPOLIS, IN 46268 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOSCANNER BEYOND GLUCOSE ANALYZER AND TEST STRIPS
POLYMER TECHNOLOGY SYSTEMS, INC. 510(k) NO: K013203(TRADITIONAL)
ATTN: MARGO ENRIGHT PHONE NO : 317-870-5610
7736 ZIONSVILLE RD. SE DECISION MADE: 16-NOV-01
INDIANAPOLIS, IN 46268 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOSS 2000-3 VACUUM ERECTION DEVICE
POS-T-VAC, INC. 510(k) NO: K012670(TRADITIONAL)
ATTN: DENNIS L BELL PHONE NO : 800-279-7434
1701 NORTH 14TH AVE. SE DECISION MADE: 09-NOV-01
P.O. BOX 1436 510(k) STATEMENT
DODGE CITY, KS 67801
DEVICE: BOSS-2000-2 VACUUM ERECTION DEVICE
POS-T-VAC, INC. 510(k) NO: K012672(TRADITIONAL)
ATTN: DENNIS L BELL PHONE NO : 316-227-7434
1701 NORTH 14TH AVE. SE DECISION MADE: 09-NOV-01
P.O. BOX 1436 510(k) STATEMENT
DODGE CITY, KS 67801
DEVICE: PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT
PRIME DENTAL MANUFACTURING, INC. 510(k) NO: K012761(TRADITIONAL)
ATTN: ROLANDO MARASIGAN PHONE NO : 773-539-5927
3735 WEST BELMONT AVE. SE DECISION MADE: 01-NOV-01
CHICAGO, IL 60618 510(k) STATEMENT
DEVICE: PRIME-DENT CHEMICAL CURE PIT & FISSURE SEALANT
PRIME DENTAL MANUFACTURING, INC. 510(k) NO: K012794(TRADITIONAL)
ATTN: ROLANDO MARASIGAN PHONE NO : 773-539-5927
3735 WEST BELMONT AVE. SE DECISION MADE: 05-NOV-01
CHICAGO, IL 60618 510(k) STATEMENT
DEVICE: GLYCOSAL II HBA 1C TEST
PROVALIS DIAGNOSTICS LTD. 510(k) NO: K011933(TRADITIONAL)
ATTN: THOMAS M TSAKERIS PHONE NO : 301-330-2076
16809 BRIARDALE ROAD SE DECISION MADE: 02-NOV-01
ROCKVILLE, MD 20855 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PSYCHEMEDICS RIA COCAINE ASSAY
PSYCHEMEDICS CORP. 510(k) NO: K010868(TRADITIONAL)
ATTN: THOMAS CAIRNS PHONE NO : 310-216-7776
5832 UPLANDER WAY SE DECISION MADE: 06-NOV-01
CULVER CITY, CA 90230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYNAPULSE 500G (DP500G) BLLOD PRESSURE MONITORING SYSTEM
PULSE METRIC, INC. 510(k) NO: K012498(TRADITIONAL)
ATTN: ROBERT DUFFY PHONE NO : 858-480-1171
11777 SORRENTO VALLEY ROAD SE DECISION MADE: 01-NOV-01
SAN DIEGO, CA 92121 510(k) STATEMENT
DEVICE: RECORDING AND STIMULATING ELECTRODE
RADIONICS, A DIVISION OF TYCO HEAL510(k) NO: K012850(TRADITIONAL)
ATTN: KEVIN J O'CONNELL PHONE NO : 781-272-1233
22 TERRY AVE. SE DECISION MADE: 19-NOV-01
BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BACTI-SWAB DRY
REMEL CO. 510(k) NO: K013711(TRADITIONAL)
ATTN: ROBERT E BOOTH PHONE NO : 913-888-0939
12076 SANTA FE DR. SE DECISION MADE: 26-NOV-01
LENEXA, KS 66215 510(k) STATEMENT
DEVICE: INFLUENZA A/B RAPID TEST, CAT NO 2158 663
ROCHE DIAGNOSTICS CORP. 510(k) NO: K011684(TRADITIONAL)
ATTN: LUANN OCHS PHONE NO : 800-428-5074
9115 HAGUE RD. SE DECISION MADE: 30-NOV-01
P.O. BOX 50457 510(k) SUMMARY AVAILABLE FROM FDA
INDIANAPOLIS, IN 46250-0457
DEVICE: TINA-QUANT COMPLEMENT C4 TEST SYSTEM
ROCHE DIAGNOSTICS CORP. 510(k) NO: K012359(TRADITIONAL)
ATTN: HELEN T TORNEY PHONE NO : 800-428-5074
9115 HAGUE ROAD SE DECISION MADE: 29-NOV-01
INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TINA-QUANT COMPLEMENT C3C TEST SYSTEM
ROCHE DIAGNOSTICS CORP. 510(k) NO: K012361(TRADITIONAL)
ATTN: HELEN T TORNEY PHONE NO : 800-428-5074
9115 HAGUE ROAD SE DECISION MADE: 29-NOV-01
INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONTRAK TESTCARD 9
ROCHE DIAGNOSTICS CORP. 510(k) NO: K012396(ABBREVIATED)
ATTN: JENNIFER TRIBBETT PHONE NO : 317-845-2000
9115 HAGUE ROAD SE DECISION MADE: 05-NOV-01
INDIANAPOLIS, IN 46256 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TINA-QUANT APOLIPOPROTEIN B VER.2
ROCHE DIAGNOSTICS CORP. 510(k) NO: K013206(TRADITIONAL)
ATTN: KAY A TAYLOR PHONE NO : 317-521-3544
9115 HAGUE ROAD SE DECISION MADE: 16-NOV-01
INDIANAPOLIS, IN 46256 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TINA-QUANT APOLIPOPROTEIN B VER.2
ROCHE DIAGNOSTICS CORP. 510(k) NO: K013207(TRADITIONAL)
ATTN: KAY A TAYLOR PHONE NO : 317-521-3544
9115 HAGUE ROAD SE DECISION MADE: 13-NOV-01
INDIANAPOLIS, IN 46256 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TINA-QUANT APOLIPOPROTEIN VER.2
ROCHE DIAGNOSTICS CORP. 510(k) NO: K013249(TRADITIONAL)
ATTN: HELEN T TORNEY PHONE NO : 317-521-7634
9115 HAGUE ROAD SE DECISION MADE: 16-NOV-01
INDIANAPOLIS, IN 46256 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TINA-QUANT APOLIPOPROTEIN A-1 VER.2
ROCHE DIAGNOSTICS CORP. 510(k) NO: K013278(TRADITIONAL)
ATTN: HELEN TORNEY PHONE NO : 317-521-7643
9115 HAGUE ROAD SE DECISION MADE: 15-NOV-01
INDIANAPOLIS, IN 46256 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMNI C ANALYZER
ROCHE DIAGNOSTICS CORP. 510(k) NO: K013373(SPECIAL)
ATTN: JENNIFER TRIBETT PHONE NO : 800-428-5074
9115 HAGUE RD. SE DECISION MADE: 02-NOV-01
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RUSCH BRONCHUS BLOCKER KIT
RUSCH INTL. 510(k) NO: K010596(TRADITIONAL)
ATTN: KARENANN J BROZOWSKI PHONE NO : 603-532-7706
50 PLANTATION DRIVE SE DECISION MADE: 21-NOV-01
JAFFERY, NH 03452 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RUSCH PERCUTANEOUS NEPHROSTOMY CATHETER SETS
RUSCH INTL. 510(k) NO: K011121(TRADITIONAL)
ATTN: JULIE A BEAUMONT PHONE NO : 603-532-0204
50 PLANTATION DRIVE SE DECISION MADE: 16-NOV-01
JAFFERY, NH 03452 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BALLPEN SPINAL NEEDLE W/WO INTRODUCER
RUSCH INTL. 510(k) NO: K011122(TRADITIONAL)
ATTN: JULIE A BEAUMONT PHONE NO : 603-532-0204
50 PLANTATION DRIVE SE DECISION MADE: 16-NOV-01
JAFFERY, NH 03452 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RUSCH POLYFLEX STENT KIT
RUSCH INTL. 510(k) NO: K013266(TRADITIONAL)
ATTN: KARENANN J BROZOWSKI PHONE NO : 603-532-0203
50 PLANTATION DRIVE SE DECISION MADE: 27-NOV-01
JAFFERY, NH 03452 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIAL
S & C POLYMER GMBH 510(k) NO: K012767(TRADITIONAL)
ATTN: CHRISTIAN BOTTCHER PHONE NO : 49 412 18619
ROBERT-BOSCH-STRABE 5 SE DECISION MADE: 01-NOV-01
ELMSHORN, GERMANY D-25335 510(k) STATEMENT
DEVICE: ISOBAR SPINAL SYSTEM
SCIENT'X 510(k) NO: K013440(SPECIAL)
ATTN: JOANNA DROEGE PHONE NO : 512-832-9500
9800 METRIC BLVD. SE DECISION MADE: 16-NOV-01
AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISOBAR SPINAL SYSTEM
SCIENT'X 510(k) NO: K013444(SPECIAL)
ATTN: JOANNA DROEGE PHONE NO : 512-832-9500
9800 METRIC BLVD. SE DECISION MADE: 16-NOV-01
AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCITON IMAGE HAIR REMOVAL LASER
SCITON, INC. 510(k) NO: K012552(TRADITIONAL)
ATTN: PETER N ALLEN PHONE NO : 650-493-9155
845 COMMERCIAL STREET SE DECISION MADE: 05-NOV-01
PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM
SEDECAL USA, , INC. 510(k) NO: K012546(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
P.O. BOX 7007 SE DECISION MADE: 02-NOV-01
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEMPERMED DERMA PLUS, SIZES 5.5,6,6.5,7,7.5,8,8.5,9
SEMPERIT TECHNISCHE PRODUKTE GESEL510(k) NO: K012819(ABBREVIATED)
ATTN: JAY MANSOUR PHONE NO : 678-908-8180
1308 MORNINGSTAR PARK DR SE DECISION MADE: 16-NOV-01
APHARETTA, GA 30022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SERIM BLOOD LEAK TEST STRIP-2
SERIM RESEARCH CORP. 510(k) NO: K012115(TRADITIONAL)
ATTN: PATRICA RUPCHOCK PHONE NO : 219-264-3440
P.O. BOX 4002 SE DECISION MADE: 30-NOV-01
ELKHART, IN 46514-0002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOTEX NITRILE EXAMINATION GLOVES POWDER-FREE
SHANGHAI MOTEX HEALTHCARE CO., LTD510(k) NO: K013261(TRADITIONAL)
ATTN: TONY T K CHENG PHONE NO : 862 159 799888
NO. 6318, FANG HUANG RD., SE DECISION MADE: 29-NOV-01
HUAXIN 510(k) SUMMARY AVAILABLE FROM FDA
QINGPU, SHANGHAI, CHINA THIRD PARTY REVIEW
DEVICE: SNAZZY2
SHOPRIDER INTL., INC. 510(k) NO: K011473(TRADITIONAL)
ATTN: CHRIS TINSLEY PHONE NO : 162 032 52629
169 KEN TZU, SHANG KEN VILLAGE SE DECISION MADE: 16-NOV-01
HSIN FENG 510(k) STATEMENT
HSIANG, HSINCHU COUNTY, CHINA (TAIWAN)
DEVICE: SOMATOM P30 CT SYSTEMS
SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K013522(TRADITIONAL)
ATTN: PRAVEEN NADKARNI PHONE NO : 732-321-4950
186 WOOD AVENUE SOUTH SE DECISION MADE: 07-NOV-01
ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096
SIGMA DIAGNOSTICS, INC. 510(k) NO: K013544(TRADITIONAL)
ATTN: WILLIAM R GILBERT II PHONE NO : 314-286-6693
545 SOUTH EWING AVE. SE DECISION MADE: 15-NOV-01
ST. LOUIS, MO 63103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221
SIGMA DIAGNOSTICS, INC. 510(k) NO: K013545(TRADITIONAL)
ATTN: WILLIAM R GILBERT II PHONE NO : 314-286-6693
545 SOUTH EWING AVE. SE DECISION MADE: 15-NOV-01
ST. LOUIS, MO 63103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SILMED NASAL SEPTAL BUTTON
SILMED INCORPORATED 510(k) NO: K013696(TRADITIONAL)
ATTN: RAMA GUNDLAPALLI PHONE NO : 219-453-3877
3987 LAKEVIEW TRAIL SE DECISION MADE: 28-NOV-01
LEESBURG,, IN 46538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEREC INLAB AND CEREC SCAN
SIRONA DENTAL SYSTEMS GMBH 510(k) NO: K012517(TRADITIONAL)
ATTN: SHEILA HEMEON-HEYER PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 01-NOV-01
NORTH ATTLEBORO, MA 02760-4153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINIME NASAL MASK, MODEL P/N 50220
SLEEPNET CORP. 510(k) NO: K013306(SPECIAL)
ATTN: PAUL R CHIESA PHONE NO : 603-624-1911
1050 PERIMETER RD., SE DECISION MADE: 02-NOV-01
LOCKHEED AIR CENTER 510(k) STATEMENT
MANCHESTER, NH 03103
DEVICE: SMART GLOVE STERILE NITRILE EXAM GLOVE
SMART GLOVE CORP. SDN BHD 510(k) NO: K012853(TRADITIONAL)
ATTN: NG YEW SOON PHONE NO : 603 329 16100
LOT 6487 BATU 5 3/4 SE DECISION MADE: 16-NOV-01
JALAN KAPAR 510(k) STATEMENT
KLANG SELANGOR, MALAYSIA 42100
DEVICE: STERILE LATEX EXAMINATION GLOVES (POWDERED) WITH PROTEIN CLAIM L
SMART GLOVE CORP. SDN BHD 510(k) NO: K012856(TRADITIONAL)
ATTN: FOO KHON PU PHONE NO : 603 329 17526
LOT 6487 BATU 5 3/4 SE DECISION MADE: 16-NOV-01
JALAN KAPAR 510(k) STATEMENT
KLANG SELANGOR, MALAYSIA 42100
DEVICE: SMITH & NEPHEW PHOENIX 5.0 ALLOGRAFT ANCHOR KIT
SMITH & NEPHEW, INC. 510(k) NO: K011985(TRADITIONAL)
ATTN: TIM CRABTREE PHONE NO : 978-749-1068
160 DASCOMB RD. SE DECISION MADE: 02-NOV-01
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273
SMITH & NEPHEW, INC. 510(k) NO: K012724(TRADITIONAL)
ATTN: JANICE HASELTON PHONE NO : 978-749-1494
160 DASCOMB RD. SE DECISION MADE: 08-NOV-01
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TORIC EYE-Q (XYLOFILCON A) SOFT (HYDROPHILIC) TORIC MULTIFOCAL C
SOFLEX CONTACT LENS INDUSTRIES LTD510(k) NO: K013467(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412
13 RED FOX LANE SE DECISION MADE: 20-NOV-01
LITTLETON, CO 80127 510(k) STATEMENT
DEVICE: EYE-Q (XYLOFILCON A) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS
SOFLEX CONTACT LENS INDUSTRIES LTD510(k) NO: K013469(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412
13 RED FOX LANE SE DECISION MADE: 20-NOV-01
LITTLETON, CO 80127 510(k) STATEMENT
DEVICE: CORRESTORE PATCH, MODELS 1.5P2, 2P3, 3P4; CORRESTORE SIZER, MODE
SOMANETICS CORP. 510(k) NO: K011487(TRADITIONAL)
ATTN: RONALD A WIDMAN PHONE NO : 248-689-3050
1653 EAST MAPLE RD. SE DECISION MADE: 21-NOV-01
TROY, MI 48083-4208 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCANTAC MEMBRANE OR SCANTAC STRIP
SONOTECH, INC. 510(k) NO: K013170(TRADITIONAL)
ATTN: MARGARET J LARSON PHONE NO : 360-671-9024
774 MARINE DR. SE DECISION MADE: 13-NOV-01
BELLINGHAM, WA 98225 510(k) STATEMENT
DEVICE: SORING GMBH SONOCA 180/190
SORING GMBH MEDIZINTECHNIK 510(k) NO: K012753(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 214-262-4209
1100 LAKEVIEW BLVD. SE DECISION MADE: 13-NOV-01
DENTON, TX 76208 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFTLOC SAFETY INFUSION SET
SPECIALIZED HEALTH PRODUCTS, INC. 510(k) NO: K013394(TRADITIONAL)
ATTN: MARK NELSON PHONE NO : 801-298-3360
585 WEST 500 SOUTH SE DECISION MADE: 08-NOV-01
BOUNTIFUL, UT 84010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C3 ANTERIOR CERVICAL PLATE SYSTEM
SPINE VISION, INC 510(k) NO: K012881(TRADITIONAL)
ATTN: DAVID W MULLIS, JR PHONE NO : 770-207-9174
BOX 39 367 PLEASANT VALLEY RD SE DECISION MADE: 26-NOV-01
GOOD HOPE, GA 30641 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERILE POWDER-FREE LATEX SURGICAL GLOVES
SSN GLOVES (M) SDN BHD 510(k) NO: K012880(TRADITIONAL)
ATTN: CLINTON A TECK LEONG PHONE NO : 603 778 12829
NO. 1, JALAN 203, OFF JALAN SE DECISION MADE: 16-NOV-01
TANDANG 510(k) STATEMENT
PETALING, JALA SELANGOR, MALAYSIA 46050
DEVICE: STERILE POWDERED LATEX SURGICAL GLOVES
SSN GLOVES (M) SDN BHD 510(k) NO: K012896(TRADITIONAL)
ATTN: CLINTON A TECK LEONG PHONE NO : 603 778 12829
NO. 1, JALAN 203, OFF JALAN SE DECISION MADE: 16-NOV-01
TANDANG 510(k) STATEMENT
PETALING, JALA SELANGOR, MALAYSIA 46050
DEVICE: STANDARD IMAGING IVB 1000 WELL CHAMBER
STANDARD IMAGING, INC. 510(k) NO: K013548(SPECIAL)
ATTN: RAYMOND RIDDLE PHONE NO : 608-831-0025
7601 MURPHY DRIVE SE DECISION MADE: 09-NOV-01
MIDDLETON, WI 53562-2766 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED POWERED ARTHROSCOPIC ACCESSORIES
STERILMED, INC. 510(k) NO: K012536(TRADITIONAL)
ATTN: PATRICK FLEISCHHACKER PHONE NO : 888-856-4870
11400 73RD AVE. NORTH SE DECISION MADE: 02-NOV-01
MAPLE GROVE, MN 55369 510(k) STATEMENT
DEVICE: REPROCESSED HARMONIC
STERILMED, INC. 510(k) NO: K012571(TRADITIONAL)
ATTN: PATRICK FLEISCHHACKER PHONE NO : 763-488-3400
11400 73RD AVE. NORTH SE DECISION MADE: 07-NOV-01
MAPLE GROVE, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED ENDOSCOPIC TROCAR
STERILMED, INC. 510(k) NO: K012578(TRADITIONAL)
ATTN: PATRICK FLEISCHHACKER PHONE NO : 763-488-3400
11400 73RD AVE N., SUITE 100 SE DECISION MADE: 07-NOV-01
MAPLE GROVE, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED PHACO TIPS
STERILMED, INC. 510(k) NO: K012579(TRADITIONAL)
ATTN: PATRICK FLEISCHHACKER PHONE NO : 763-488-3400
11400 73RD AVE N., SUITE 100 SE DECISION MADE: 08-NOV-01
MAPLE GROVE, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED LAPAROSCOPIC ELECTRIC INSTUMENTS
STERILMED, INC. 510(k) NO: K012598(TRADITIONAL)
ATTN: PATRICK F FLEISCHHACKER PHONE NO : 763-488-3400
11400 73RD AVE. NORTH SE DECISION MADE: 07-NOV-01
MAPLE GROVE, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED RF ARTHROSCOPY PROBES
STERILMED, INC. 510(k) NO: K012679(TRADITIONAL)
ATTN: PATRICK FLEISCHHACKER PHONE NO : 888-856-4870
11400 73RD AVE. NORTH SE DECISION MADE: 08-NOV-01
MAPLE GROVE, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED LASER PROBE
STERILMED, INC. 510(k) NO: K012682(TRADITIONAL)
ATTN: PATRICK FLEISCHHACKER PHONE NO : 888-856-4870
11400 73RD AVE. NORTH SE DECISION MADE: 08-NOV-01
MAPLE GROVE, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED LIGHT PIPES
STERILMED, INC. 510(k) NO: K012683(TRADITIONAL)
ATTN: PATRICK FLEISCHHACKER PHONE NO : 888-856-4870
11400 73RD AVE. NORTH SE DECISION MADE: 08-NOV-01
MAPLE GROVE, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVERSTICK
STICK TECH LTD. 510(k) NO: K011788(TRADITIONAL)
ATTN: WILLIAM M TROETEL PHONE NO : 914-664-1640
80 PARKWAY WEST SE DECISION MADE: 05-NOV-01
MOUNT VERNON, NY 10552 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVERSTICKNET
STICK TECH LTD. 510(k) NO: K011799(TRADITIONAL)
ATTN: WILLIAM M TROETEL PHONE NO : 914-664-1640
80 PARKWAY WEST SE DECISION MADE: 05-NOV-01
MOUNT VERNON, NY 10552 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SICKLE-CHEX
STRECK LABORATORIES, INC. 510(k) NO: K013316(TRADITIONAL)
ATTN: PAUL KITTELSON PHONE NO : 402-537-5312
7002 SOUTH 109TH ST. SE DECISION MADE: 06-NOV-01
LA VISTA, NE 68128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEPTUNE WASTE MANAGEMENT STSTEM
STRYKER INSTRUMENTS 510(k) NO: K012991(TRADITIONAL)
ATTN: SUZANNE VELAZQUEZ PHONE NO : 616-323-7700
4100 EAST MILHAM AVE. SE DECISION MADE: 29-NOV-01
KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCREW VENT IMPLANT; TAPERED SCREW VENT IMPLANT
SULZER DENTAL, INC. 510(k) NO: K013227()
ATTN: FOSTER BOOP PHONE NO : 760-929-4300
1900 ASTON AVE. SE DECISION MADE: 19-NOV-01
CARLSBAD, CA 92008-7308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONVERGE ACETABULAR SYSTEM
SULZER ORTHOPEDICS, INC. 510(k) NO: K012739(TRADITIONAL)
ATTN: MITCHELL A DHORITY PHONE NO : 512-432-9202
9900 SPECTRUM DR. SE DECISION MADE: 14-NOV-01
AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MO
SURGIN SURGICAL INSTRUMENTATION, I510(k) NO: K011195(TRADITIONAL)
ATTN: DON HAAR PHONE NO : 714-832-6300
14762 BENTLEY CIRCLE SE DECISION MADE: 06-NOV-01
TUSTIN, CA 92680 510(k) STATEMENT
DEVICE: CAPIOX RX HARDSHELL RESERVOIR
TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K013526(SPECIAL)
ATTN: GARRY A COURTNEY PHONE NO : 800-283-7866
125 BLUE BALL ROAD SE DECISION MADE: 15-NOV-01
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAROTID GUIDING SHEATH
TERUMO MEDICAL CORP. 510(k) NO: K012812(TRADITIONAL)
ATTN: YUK-TING LEWIS PHONE NO : 410-392-7213
950 ELKTON BLVD. SE DECISION MADE: 14-NOV-01
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RENAL GUIDING SHEATH
TERUMO MEDICAL CORP. 510(k) NO: K012854(TRADITIONAL)
ATTN: YUK-TING LEWIS PHONE NO : 410-392-7213
125 BLUE BALL ROAD SE DECISION MADE: 21-NOV-01
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLIRANS E-SERIES DIALYZER
TERUMO MEDICAL CORP. 510(k) NO: K013550(SPECIAL)
ATTN: SANDI HARTKA PHONE NO : 410-392-7243
125 BLUE BALL ROAD SE DECISION MADE: 20-NOV-01
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BITEM ANGEL RELINE KIT, BITEM LABORATORY KIT, MODELS 120110, 120
THERMOELASTIC TECHNOLOGIES, INC. 510(k) NO: K012882(TRADITIONAL)
ATTN: ART WARD PHONE NO : 813-645-2855
962 ALLEGRO LANE SE DECISION MADE: 14-NOV-01
APOLLO BEACH, FL 33572 510(k) STATEMENT
DEVICE: HPI SENSI GRIP STERILE POWDERED LATEX SURGICAL GLOVE,WITH LABELE
TILLOTSON HEALTHCARE CORP. 510(k) NO: K013324(TRADITIONAL)
ATTN: F.W. PERRELLA PHONE NO : 603-472-6600
360 ROUTE 101 W SE DECISION MADE: 29-NOV-01
BEDFORD, NH 03110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL RADIOGRAPHY SYSTEM, MODEL DFP-8000D
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K013608(TRADITIONAL)
ATTN: DIANA THORSON PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 15-NOV-01
P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92781-2068 THIRD PARTY REVIEW
DEVICE: SSA-770A, APLIO ULTRASOUND SYSTEM
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K013633(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 13-NOV-01
P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92781-2068 THIRD PARTY REVIEW
DEVICE: SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K012921(TRADITIONAL)
ATTN: CYNTHIA C KNAPP PHONE NO : 800-216-9036
29299 CLEMENS RD., SUITE 1-K SE DECISION MADE: 02-NOV-01
WESTLAKE, OH 44145 510(k) STATEMENT
DEVICE: SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K013075(TRADITIONAL)
ATTN: CYNTHIA C KNAPP PHONE NO : 800-216-9036
29299 CLEMENS RD. SUITE 1-K SE DECISION MADE: 26-NOV-01
WESTLAKE, OH 44145 510(k) STATEMENT
DEVICE: HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP)MIC SUSCEPTIBILITY PLAT
TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K013195(TRADITIONAL)
ATTN: CYNTHIA C KNAPP PHONE NO : 800-216-9036
29299 CLEMENS RD., SUITE 1-K SE DECISION MADE: 07-NOV-01
WESTLAKE, OH 44145 510(k) STATEMENT
DEVICE: HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K013368(TRADITIONAL)
ATTN: CYNTHIA C KNAPP PHONE NO : 800-216-9036
29299 CLEMENS RD., SUITE 1-K SE DECISION MADE: 20-NOV-01
WESTLAKE, OH 44145 510(k) STATEMENT
DEVICE: HELICAL COMPRESSION ANCHOR SYSTEM, NON-CANNULATED
TRIAGE MEDICAL INC 510(k) NO: K012817(TRADITIONAL)
ATTN: GREG HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 20-NOV-01
IRVINE, CA 92606 510(k) STATEMENT
DEVICE: HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED SINGLE HELIX
TRIAGE MEDICAL INC 510(k) NO: K012818(TRADITIONAL)
ATTN: GREG H HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 20-NOV-01
IRVINE, CA 92606 510(k) STATEMENT
DEVICE: UNI-GOLD STREP A TEST KIT
TRINITY BIOTECH, PLC 510(k) NO: K011709(TRADITIONAL)
ATTN: FIONA CAMPBELL PHONE NO : 011 353 12769800
IDA BUSINESS PARK SE DECISION MADE: 08-NOV-01
BRAY, IRELAND 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORALLITE COMPREHENSIVE EXAM TRAY
TRYLON CORP. 510(k) NO: K012070(TRADITIONAL)
ATTN: MARTIN L LONKY PHONE NO : 310-327-8820
970 WEST 190TH ST., SUITE 850 SE DECISION MADE: 27-NOV-01
TORRANCE, CA 90502-1037 510(k) STATEMENT
DEVICE: CLEARBLUE EASY EARLY RESULT PREGNANCY TEST
UNIPATH LTD. 510(k) NO: K013372(SPECIAL)
ATTN: STEVEN H ARMSTRONG PHONE NO : 212-418-8515
390 PARK AVENUE SE DECISION MADE: 09-NOV-01
NEW YORK, NY 10022-4698 510(k) STATEMENT
DEVICE: VT-1
V.T.S.,INC. 510(k) NO: K012619(TRADITIONAL)
ATTN: DENNIS L BELL PHONE NO : 866-344-6044
701 S. MAIN SE DECISION MADE: 09-NOV-01
NEWKIRK, OK 74647 510(k) STATEMENT
DEVICE: SE-200
V.T.S.,INC. 510(k) NO: K012620(TRADITIONAL)
ATTN: DENNIS L BELL PHONE NO : 866-344-6044
701 S. MAIN SE DECISION MADE: 09-NOV-01
NEWKIRK, OK 74647 510(k) STATEMENT
DEVICE: VANGUARD REPROCESSED PHACOEMULSIFICATION
VANGUARD MEDICAL CONCEPTS, INC. 510(k) NO: K012698(TRADITIONAL)
ATTN: MIKE SAMMON PHONE NO : 863-683-8680
5307 GREAT OAK DR. SE DECISION MADE: 09-NOV-01
LAKELAND, FL 33815 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VANGUARD REPROCESSED ENDOSCOPIC INSTRUMENTS
VANGUARD MEDICAL CONCEPTS, INC. 510(k) NO: K012700(TRADITIONAL)
ATTN: MIKE SAMMON PHONE NO : 863-683-8680
5307 GREAT OAK DR. SE DECISION MADE: 07-NOV-01
LAKELAND, FL 33815 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTROLLED EXPANSIO
VASCULAR ARCHITECTS, INC. 510(k) NO: K012544(TRADITIONAL)
ATTN: JEAN M CAILLOUETTE PHONE NO : 408-392-7437
1830 BERING DR. SE DECISION MADE: 15-NOV-01
SAN JOSE, CA 95112-4226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SE-300 VACUUM THERAPY SYSTEM
VTS, INC. 510(k) NO: K012639(TRADITIONAL)
ATTN: DENNIS L BELL PHONE NO : 866-344-6044
701 S. MAIN STREET SE DECISION MADE: 09-NOV-01
NEWKIRK, OK 74647 510(k) STATEMENT
DEVICE: SE-100 VACUUM ERECTION DEVICE
VTS, INC. 510(k) NO: K012662(TRADITIONAL)
ATTN: DENNIS L BELL PHONE NO : 866-344-6044
701 S. MAIN STREET SE DECISION MADE: 09-NOV-01
NEWKIRK, OK 74647 510(k) STATEMENT
DEVICE: CARDIOVASCULAR ARRAY
W.L. GORE & ASSOCIATES,INC 510(k) NO: K013810(TRADITIONAL)
ATTN: TRACEY D WOLF PHONE NO : 302-292-4720
1901 BARKSDALE ROAD SE DECISION MADE: 27-NOV-01
NEWARK, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: W.O.M. LASER U100
W.O.M. WORLD OF MEDICINE, GMBH 510(k) NO: K011175(TRADITIONAL)
ATTN: MICHAEL MCGRAIL PHONE NO : 617-868-3995
91 TROWBRIDGE STREET SE DECISION MADE: 01-NOV-01
# 21 510(k) SUMMARY AVAILABLE FROM FDA
CAMBRIDGE, MA 02138
DEVICE: LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW
WALTER LORENZ SURGICAL, INC. 510(k) NO: K013557(SPECIAL)
ATTN: TRACY J BICKEL PHONE NO : 219-267-6639
P.O. BOX 587 SE DECISION MADE: 16-NOV-01
WARSAW,, IN 46581-0578 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOPORTA G, MODEL 2052
WIELAND EDELMETALLE GMBH & CO. 510(k) NO: K012826(TRADITIONAL)
ATTN: GERHARD POLZER PHONE NO : 497 231 3705219
SCHWENNINGER STRABE 13 SE DECISION MADE: 01-NOV-01
PFORZHEIM, GERMANY D-75179 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORTA AURIUM, MODEL 2067
WIELAND EDELMETALLE GMBH & CO. 510(k) NO: K012827(TRADITIONAL)
ATTN: GERHARD POLZER PHONE NO : 497 231 3705219
SCHWENNINGER STRABE 13 SE DECISION MADE: 01-NOV-01
PFORZHEIM, GERMANY D-75179 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORTA SMK 82, MODEL 2032
WIELAND EDELMETALLE GMBH & CO. 510(k) NO: K012828(TRADITIONAL)
ATTN: GERHARD POLZER PHONE NO : 497 231 3705219
SCHWENNINGER STRABE 13 SE DECISION MADE: 01-NOV-01
D-75179 PFORZHEIM, GERMANY 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIO PORTADUR, ORDER-NO.:2017
WIELAND EDELMETALLE GMBH & CO. 510(k) NO: K012831(TRADITIONAL)
ATTN: GERHARD POLZER PHONE NO : 497 231 3705219
SCHWENNINGER STRABE 13 SE DECISION MADE: 01-NOV-01
PFORZHEIM, GERMANY D-75179 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORTA GEO TI MODEL #2004
WIELAND EDELMETALLE GMBH & CO. 510(k) NO: K012834(TRADITIONAL)
ATTN: GEHARD POLZER PHONE NO : 497 231 3705219
SCHWENNINGER STRABE 13 SE DECISION MADE: 01-NOV-01
D-75179 PFORZHEIM, GERMANY 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORTA MAXIMUM, MODEL# 2066
WIELAND EDELMETALLE GMBH & CO. 510(k) NO: K012835(TRADITIONAL)
ATTN: GERHARD POLZER PHONE NO : 497 231 3705219
SCHWENNINGER STRABE 13 SE DECISION MADE: 01-NOV-01
D-75179 PFORZHEIM, GERMANY 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUO PAL 6, ORDER-NO.: 2154
WIELAND EDELMETALLE GMBH & CO. 510(k) NO: K012841(TRADITIONAL)
ATTN: GERHARD POLZER PHONE NO : 49 723 13705219
SCHWENNINGER STRABE 13 SE DECISION MADE: 20-NOV-01
PFORZHEIM, GERMANY D-75179 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORTADUR P 2, MODEL #2031
WIELAND EDELMETALLE GMBH & CO. 510(k) NO: K012843(TRADITIONAL)
ATTN: GEHARD POLZER PHONE NO : 497 231 3705219
SCHWENNINGER STRABE 13 SE DECISION MADE: 02-NOV-01
D-75179 PFORZHEIM, GERMANY 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001
WIENER LABORATORIES S.A.I.C. 510(k) NO: K012326(TRADITIONAL)
ATTN: VIVIANA CETOLA PHONE NO : 543 414 329191
2944 RIOBAMBA SE DECISION MADE: 08-NOV-01
ROSARIO, ARGENTINA 2000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML
WIENER LABORATORIES S.A.I.C. 510(k) NO: K013095(TRADITIONAL)
ATTN: VIVIANA CETOLA PHONE NO : 543 414 851982
2944 RIOBAMBA SE DECISION MADE: 16-NOV-01
ROSARIO, ARGENTINA 2000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003
WIENER LABORATORIES S.A.I.C. 510(k) NO: K013097(TRADITIONAL)
ATTN: VIVIANA CETOLA PHONE NO : 543 414 851982
2944 RIOBAMBA SE DECISION MADE: 13-NOV-01
ROSARIO, ARGENTINA 2000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WIENER LAB. AMILASA 405 CINETICA AA, WIENER LAB.AMILASA 405 CINE
WIENER LABORATORIES S.A.I.C. 510(k) NO: K013101(TRADITIONAL)
ATTN: VIVIANA CETOLA PHONE NO : 543 414 329191
2944 RIOBAMBA SE DECISION MADE: 16-NOV-01
ROSARIO, ARGENTINA 2000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 S
WIENER LABORATORIES S.A.I.C. 510(k) NO: K013102(TRADITIONAL)
ATTN: VIVIANA CETOLA PHONE NO : 543 414 851982
2944 RIOBAMBA SE DECISION MADE: 13-NOV-01
ROSARIO, ARGENTINA 2000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WIENER LAB. GOT (AST) UV AA. WEINER LAB. GOT (AST) UV UNITEST, M
WIENER LABORATORIES S.A.I.C. 510(k) NO: K013145(TRADITIONAL)
ATTN: VIVIANA CETOLA PHONE NO : 543 414 329191
2944 RIOBAMBA SE DECISION MADE: 27-NOV-01
ROSARIO, ARGENTINA 2000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEREINE EXTRA STRENGTH DAILY CLEANER
WILSA, INC. 510(k) NO: K011561(TRADITIONAL)
ATTN: SALLY COOK PHONE NO : 303-936-1137
2172 SOUTH JASON ST. SE DECISION MADE: 20-NOV-01
DENVER, CO 80223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVANCE UNICONDYLAR KNEE SYSTEM
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K012591(ABBREVIATED)
ATTN: EHAB M ESMAIL PHONE NO : 901-867-4732
5677 AIRLINE RD. SE DECISION MADE: 02-NOV-01
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEVICE MODIFICATION OF ENTERAL FEEDING SETS FOR GRAVITY AND PUMP
ZEVEX, INC. 510(k) NO: K012147(SPECIAL)
ATTN: SUSAN P SCHMIDT PHONE NO : 801-264-1001
4314 ZEVEX PARK LN. SE DECISION MADE: 02-NOV-01
SALT LAKE CITY, UT 84123 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 313
TOTAL WITH SUMMARIES 249
TOTAL WITH STATEMENTS 64
Updated 4/28/2004
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