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Medical Devices
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December 2001 510(k) Clearances
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE)
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD 01-DEC-2001 THROUGH 31-DEC-2001
DEVICE: 3D LINE STEROTACTIC HARDWARE ACCESSORIES
3D LINE USA, INC. 510(k) NO: K011255(TRADITIONAL)
ATTN: KAREN H RIGAMONTI PHONE NO : 410-580-1730
2807 OLD COURT ROAD SE DECISION MADE: 20-DEC-01
BALTIMORE, MD 21208 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ETHANOL
ABBOTT LABORATORIES 510(k) NO: K013538(TRADITIONAL)
ATTN: ALICIA SIMPSON PHONE NO : 972-518-7864
1920 HURD DRIVE, MS 8-21 SE DECISION MADE: 14-DEC-01
IRVING, TX 75038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005
ACKARD LABORATORIES 510(k) NO: K013972(SPECIAL)
ATTN: RICHARD HETTENBACH PHONE NO : 908-276-6290
70 JACKSON DR. SE DECISION MADE: 17-DEC-01
P.O. BOX 1085 510(k) SUMMARY AVAILABLE FROM FDA
CRANFORD, NJ 07016
DEVICE: ACON MOP ONE STEP OPIATE TEST STRIP, ACON MOP STEP OPIATE TEST D
ACON LABORATORIES, INC. 510(k) NO: K013380(TRADITIONAL)
ATTN: EDWARD TUNG PHONE NO : 858-535-2030
4108 SORRENTO VALLEY BLVD. SE DECISION MADE: 18-DEC-01
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLARUS CAP SCREW
ACUMED, INC. 510(k) NO: K013616(TRADITIONAL)
ATTN: SHARI JEFFERS PHONE NO : 503-627-9957
10950 S.W. 5TH ST., SUITE 170 SE DECISION MADE: 19-DEC-01
BEAVERTON, OR 97005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DURAPRENE STERILE SYNTHETIC POWDER-FREE SURGICAL GLOVES WITH TES
ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K013302(TRADITIONAL)
ATTN: ERICA SETHI PHONE NO : 847-785-3337
1500 WAUKEGAN RD. BLDG. WM SE DECISION MADE: 17-DEC-01
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED SOFT TISSUE ABLATORS
ALLIANCE MEDICAL CORP. 510(k) NO: K012631(TRADITIONAL)
ATTN: DON SELVEY PHONE NO : 480-763-5300
10232 SOUTH 51ST ST. SE DECISION MADE: 06-DEC-01
PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO:APEX MEDICAL IF-4100
APEX MEDICAL CORP. 510(k) NO: K013813(SPECIAL)
ATTN: ALAN CHANGE PHONE NO : 886 226 954170
10TH FL., NO. 31, LANE 169, SE DECISION MADE: 14-DEC-01
KANG NING ST. 510(k) STATEMENT
HSI CHIH CHEN, TAIPEI HSIEN, CHINA (TAIWAN)
DEVICE: REMEDY MODEL 2Z12
APOLLO CORP. 510(k) NO: K012029(TRADITIONAL)
ATTN: ADRIAN SWEEN PHONE NO : 715-247-5625
450 MAIN ST. SE DECISION MADE: 31-DEC-01
SOMERSET, WI 54025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APPLIED ACCESS SEAL
APPLIED MEDICAL RESOURCES CORP. 510(k) NO: K012968(TRADITIONAL)
ATTN: ANIL BHALANI PHONE NO : 949-713-8327
22872 AVENIDA EMPRESSA SE DECISION MADE: 03-DEC-01
RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FILTERFLO H
ARC MEDICAL, INC. 510(k) NO: K011212(TRADITIONAL)
ATTN: HAL NORRIS PHONE NO : 800-950-2720
322 PATTERSON AVE. SE DECISION MADE: 20-DEC-01
SCOTTDALE, GA 30079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLUE LATEX EXAMINATION GLOVES, POWDER FREE
ARISTA LATINDO INDUSTRIAL, LTD. P.510(k) NO: K013320(TRADITIONAL)
ATTN: LINGA SUMARTA PHONE NO : 622 166 20201195
128 JALAN KYAI HAJI MUHAMMAD SE DECISION MADE: 19-DEC-01
MANSYUR 510(k) STATEMENT
JAKARTA BARAT, INDONESIA 11210
DEVICE: ENDOFLIP
ATLANTECH MEDICAL DEVICES LTD. 510(k) NO: K013334(TRADITIONAL)
ATTN: NICK WOODS PHONE NO : 44 142 3888806
38 FREEMANS WAY SE DECISION MADE: 13-DEC-01
HARROGATE, NORTH YORKSHIRE, UNITED510(k) STATEMENT
DEVICE: AUTOGENESIS AUTOMATOR, MODEL M1000
AUTOGENESIS, INC. 510(k) NO: K013818(SPECIAL)
ATTN: JAMES EDWARDS PHONE NO : 410-665-2017
8700 OLD HARFORD RD. SE DECISION MADE: 05-DEC-01
BALTIMORE, MD 21234 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVID-NIT PLASTIC HUB LUTZ EPIDURAL NEEDLE,MODEL RP2035L, AVID-NI
AVID N.I.T., INC. 510(k) NO: K013231(TRADITIONAL)
ATTN: SCOTT HENDERSON PHONE NO : 813-818-8705
390 SCARLET BLVD. SE DECISION MADE: 03-DEC-01
OLDSMAR, FL 34677 510(k) STATEMENT
DEVICE: HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C
BAXTER HEALTHCARE CORP. 510(k) NO: K012988(TRADITIONAL)
ATTN: DAVID E CURTIN PHONE NO : 847-473-6079
1620 WAUKEGAN RD. SE DECISION MADE: 05-DEC-01
MPGR-A2E 510(k) SUMMARY AVAILABLE FROM FDA
MCGAW PARK, IL 60085
DEVICE: BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEM
BAYER CORP. 510(k) NO: K012337(TRADITIONAL)
ATTN: KENNETH T EDDS PHONE NO : 914-524-2446
511 BENEDICT AVE. SE DECISION MADE: 06-DEC-01
TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
BAYER CORP. 510(k) NO: K013568(TRADITIONAL)
ATTN: KENNETH T EDDS PHONE NO : 914-524-2446
511 BENEDICT AVE. SE DECISION MADE: 21-DEC-01
TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGG ASSAY
BAYER DIAGNOSTICS CORP. 510(k) NO: K012183(TRADITIONAL)
ATTN: BARBARA PREISEL-SIMMONS PHONE NO : 508-359-7711
63 NORTH STREET SE DECISION MADE: 27-DEC-01
MEDFIELD, MA 02052 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVIA CENTAUR HOMOCYSTEINE ASSAY
BAYER DIAGNOSTICS CORP. 510(k) NO: K013406(TRADITIONAL)
ATTN: KENNETH T EDDS PHONE NO : 914-524-2446
511 BENEDICT AVE SE DECISION MADE: 18-DEC-01
TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACS 180 HOMOCYSTEINE ASSAY
BAYER DIAGNOSTICS CORP. 510(k) NO: K013606(TRADITIONAL)
ATTN: KENNETH T EDDS PHONE NO : 914-524-2446
511 BENEDICT AVE SE DECISION MADE: 21-DEC-01
TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNCHRON SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOMYCIN
BECKMAN COULTER, INC. 510(k) NO: K013076(TRADITIONAL)
ATTN: MARY BETH TANG PHONE NO : 714-961-3777
200 SOUTH KRAEMER BLVD.,W-104 SE DECISION MADE: 12-DEC-01
BREA, CA 92822-8000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMUNO-TROL LOW CELLS
BECKMAN COULTER, INC. 510(k) NO: K013842(TRADITIONAL)
ATTN: LOURDES COBA PHONE NO : 305-380-4079
11800 SW 147TH AVENUE SE DECISION MADE: 13-DEC-01
MIAMI, FL 33196-2500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND
BECKMAN COULTER, INC. 510(k) NO: K014034(SPECIAL)
ATTN: ANNETTE HELLIE PHONE NO : 714-993-8767
200 SOUTH KRAEMER BLVD. SE DECISION MADE: 18-DEC-01
BREA, CA 92822 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGU
BECTON DICKINSON INFUSION THERAPY 510(k) NO: K013800(TRADITIONAL)
ATTN: LESLIE WOOD PHONE NO : 801-565-2504
9450 SOUTH STATE ST. SE DECISION MADE: 21-DEC-01
SANDY, UT 84070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE
BIOLITEC, INC. 510(k) NO: K013193(TRADITIONAL)
ATTN: CAROL J MORELLO PHONE NO : 413-525-0600
515 SHAKER ROAD SE DECISION MADE: 21-DEC-01
EAST LONGMEADOW, MA 01028 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESORBABLE NO PROFILE SCREW AND WASHER
BIOMET MANUFACTURING, INC. 510(k) NO: K012469(TRADITIONAL)
ATTN: SARA B SHULTZ PHONE NO : 219-267-6639
P.O. BOX 587 SE DECISION MADE: 03-DEC-01
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SELF-COUNTERSINKING BONE SCREW
BIOMET ORTHOPEDICS, , INC. 510(k) NO: K013534(TRADITIONAL)
ATTN: SARA B SHULTZ PHONE NO : 219-267-6639
P.O. BOX 587 SE DECISION MADE: 17-DEC-01
WARSAW, IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: BIOMET HUMERAL CABLE PLATES
BIOMET ORTHOPEDICS, , INC. 510(k) NO: K013657(SPECIAL)
ATTN: TRACY J BICKEL PHONE NO : 219-267-6639
P.O. BOX 587 SE DECISION MADE: 03-DEC-01
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LORENZ LACTOSORB PANELS AND FASTENERS
BIOMET, INC. 510(k) NO: K011139(TRADITIONAL)
ATTN: TRACY J BICKEL PHONE NO : 219-372-1761
AIRPORT INDUSTRIAL PARK SE DECISION MADE: 20-DEC-01
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: REUNITE FUSION SCREW
BIOMET, INC. 510(k) NO: K011451(TRADITIONAL)
ATTN: SARA BAILEY SHULTZ PHONE NO : 219-372-1568
P.O. BOX 587 SE DECISION MADE: 10-DEC-01
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: INJECTABLE MIMIX
BIOMET, INC. 510(k) NO: K012569(SPECIAL)
ATTN: SARA B SHULTZ PHONE NO : 219-267-6639
56 EAST BELL DRIVE SE DECISION MADE: 21-DEC-01
PO BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46582
DEVICE: SOFT TISSUE SCREW AND WASHER
BIOMET, INC. 510(k) NO: K012572(TRADITIONAL)
ATTN: SARA B SHULTZ PHONE NO : 219-267-6639
56 EAST BELL DRIVE SE DECISION MADE: 03-DEC-01
PO BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0578
DEVICE: GENERATION 4 BONE CEMENT
BIOMET, INC. 510(k) NO: K993836(TRADITIONAL)
ATTN: MARY VERSTYNEN PHONE NO : 219-267-6639
AIRPORT INDUSTRIAL PARK SE DECISION MADE: 19-DEC-01
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM
BIOPLATE, INC. 510(k) NO: K013050(TRADITIONAL)
ATTN: CAROL E JONES PHONE NO : 323-549-9500
6911 MELROSE AVE. SE DECISION MADE: 10-DEC-01
LOS ANGELES, CA 90038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM
BIOPLATE, INC. 510(k) NO: K013055(TRADITIONAL)
ATTN: CAROL E JONES PHONE NO : 323-549-9500
6911 MELROSE AVE. SE DECISION MADE: 07-DEC-01
LOS ANGELES, CA 90038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOTEQUE VAGINAL PESSARIES
BIOTEQUE AMERICA, INC. 510(k) NO: K013289(TRADITIONAL)
ATTN: DENIS DORSEY PHONE NO : 215-750-8071
340 EAST MAPLE AVE., #204-C SE DECISION MADE: 27-DEC-01
LANGHORNE, PA 19047 510(k) STATEMENT
DEVICE: ASMOTOM AUTOMATED TREPHINE SYSTEM
BKG OPTHALMICS USA, INC. 510(k) NO: K013151(TRADITIONAL)
ATTN: ART WARD PHONE NO : 813-645-2855
962 ALLEGRO LANE SE DECISION MADE: 14-DEC-01
APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTITAK SUTURE SNAP SYSTEM
BONUTTI RESEARCH, INC. 510(k) NO: K013177(TRADITIONAL)
ATTN: PATRICK BALSMANN PHONE NO : 217-342-3412
2600 SOUTH RANEY SE DECISION MADE: 19-DEC-01
P.O. BOX 1367 510(k) SUMMARY AVAILABLE FROM FDA
EFFINGHAM, IL 62401
DEVICE: CONVOY ADVANCED DELIVERY SHEATH KIT
BOSTON SCIENTIFIC 510(k) NO: K013866(SPECIAL)
ATTN: ANDREA L RUTH PHONE NO : 408-895-3625
2710 ORCHARD PARKWAY SE DECISION MADE: 14-DEC-01
SAN JOSE, CA 95134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRA -THIN SDS BALLOON DILATATION CATHETER
BOSTON SCIENTIFIC CORP. 510(k) NO: K011889(TRADITIONAL)
ATTN: JENNIFER BOLTON PHONE NO : 508-652-5972
ONE BOSTON SCIENTIFIC PLACE SE DECISION MADE: 21-DEC-01
NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 16
BOSTON SCIENTIFIC, TARGET 510(k) NO: K013789(SPECIAL)
ATTN: GEORGE J PRENDERGAST PHONE NO : 510-440-7604
47900 BAYSIDE PARKWAY SE DECISION MADE: 06-DEC-01
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PAIN CARE 3200
BREG, INC. 510(k) NO: K013928(SPECIAL)
ATTN: KATHLEEN BARBER PHONE NO : 760-599-3000
2611 COMMERCE WAY SE DECISION MADE: 03-DEC-01
VISTA, CA 92083 510(k) STATEMENT
DEVICE: CORLINK AAD (3.5 TO 6.0 M M OUTER DIAMETER VESSELS),MODEL 200-06
BYPASS LTD. 510(k) NO: K011589(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5910
555 THIRTEENTH STREET NW SE DECISION MADE: 26-DEC-01
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAIRD TECHNOLOGY HOLTER 2000
CAIRD TECHNOLOGY 510(k) NO: K012686(TRADITIONAL)
ATTN: JAMES H BROWN PHONE NO : 803-736-1289
205 CAMDEN CHASE SE DECISION MADE: 13-DEC-01
COLUMBIA, SC 29223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPIRIT 300
CAIRE, INC. 510(k) NO: K013251(TRADITIONAL)
ATTN: ROGER BRIESE PHONE NO : 952-882-5071
3505 COUNTY RD. 42 WEST SE DECISION MADE: 18-DEC-01
BURNSVILLE, MN 55306-3803 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: INVERNESS MEDICAL EARLY PREGNANCY TEST
CAMBRIDGE DIAGNOSTICS IRELAND, LTD510(k) NO: K013907(SPECIAL)
ATTN: AVRIL MURRAY PHONE NO : 011 353 91757534
MERVUE BUSINESS PARK SE DECISION MADE: 18-DEC-01
GALWAY, IRELAND 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROJET QUARK, MODEL U100 OR U40
CANE SRL 510(k) NO: K013807(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
P.O. BOX 7007 SE DECISION MADE: 12-DEC-01
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
CANOPUS MEDICAL SUPPLY CO., LTD. 510(k) NO: K013753(TRADITIONAL)
ATTN: ELIZABETH DENG PHONE NO : 909-465-9188
13808 MAGNOLIA AVE. SE DECISION MADE: 10-DEC-01
CHINO, CA 91710 510(k) STATEMENT
DEVICE: "DATACAPTOR"
CAPSULE TECHNOLOGIE 510(k) NO: K013019(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 18-DEC-01
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MALLEABLE SURGICAL LIGHTSTIC 180, MODEL 180 (1CM-9CM)
CARDIOFOCUS, INC. 510(k) NO: K013901(SPECIAL)
ATTN: JOSEPH CURTIS PHONE NO : 508-285-1700
10 COMMERCE WAY SE DECISION MADE: 20-DEC-01
NORTON, MA 02766 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLO-CARE PLUS MULTIPURPOSE SOLUTION
CIBA VISION CORP. 510(k) NO: K012731(TRADITIONAL)
ATTN: STEVEN DOWDLEY PHONE NO : 687-415-3897
11460 JOHNS CREEK PKWY. SE DECISION MADE: 26-DEC-01
DULUTH, GA 30097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
CIBA VISION CORP. 510(k) NO: K013512(TRADITIONAL)
ATTN: STEVEN DOWDLEY PHONE NO : 687-415-3897
11460 JOHNS CREEK PKWY. SE DECISION MADE: 20-DEC-01
DULUTH, GA 30097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633
CIRCON VIDEO 510(k) NO: K011849(TRADITIONAL)
ATTN: WAYNE B STERNER PHONE NO : 805-685-5100
6500 HOLLISTER AVE. SE DECISION MADE: 10-DEC-01
SANTA BARBARA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER
CIVCO MEDICAL INSTRUMENTS CO., INC510(k) NO: K013721(TRADITIONAL)
ATTN: THERESA LEINEN PHONE NO : 319-656-4447
102 FIRST ST. SOUTH SE DECISION MADE: 28-DEC-01
KALONA, IA 52247 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPINE SCOPE, MODEL 2180
CLARUS MEDICAL, LLC. 510(k) NO: K011454(TRADITIONAL)
ATTN: TOM BARTHEL PHONE NO : 763-525-8401
1000 BOONE AVE. NORTH SE DECISION MADE: 13-DEC-01
MINNEAPOLIS, MN 55427 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CODMAN SLIM-LOC SYSTEM
CODMAN & SHURTLEFF, INC. 510(k) NO: K013877(SPECIAL)
ATTN: KATHRYN WUNDER PHONE NO : 508-880-8351
325 PARAMOUNT DR. SE DECISION MADE: 19-DEC-01
RAYNHAM, MA 02767-0350 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNERGY FLOW
COLTENE/WHALEDENT, INC. 510(k) NO: K013400(TRADITIONAL)
ATTN: H.J. VOGELSTEIN PHONE NO : 201-512-8000
750 CORPORATE DR. SE DECISION MADE: 10-DEC-01
MAHWAH, NJ 07430-2009 510(k) STATEMENT
DEVICE: SOCRATES ROBOTIC TELEMONITORING SYSTEM
COMPUTER MOTION, INC. 510(k) NO: K013804(SPECIAL)
ATTN: DAVID U THOMAS PHONE NO : 805-968-9600
130 CREMONA DRIVE, SUITE B SE DECISION MADE: 10-DEC-01
GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FOCAL SIM
COMPUTERIZED MEDICAL SYSTEMS, INC.510(k) NO: K013112(TRADITIONAL)
ATTN: MICHAEL A PARSONS PHONE NO : 314-993-0003
1145 CORPORATE LAKE DR. SE DECISION MADE: 05-DEC-01
ST. LOUIS, MO 63132-1716 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COSMETICA (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSES
CONTACT COLOR SRL 510(k) NO: K011893(TRADITIONAL)
ATTN: MARIA E DONAWA PHONE NO : 390 657 82665
VIA FONTE DI FAUNO, 22 SE DECISION MADE: 06-DEC-01
ROME, ITALY 00153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHAPEABLE DOPPLER FLOW PROBE
COOK VASCULAR, INC. 510(k) NO: K002958(TRADITIONAL)
ATTN: THOMAS J KARDOS PHONE NO : 724-845-8621
RT. 66, RIVER RD. SE DECISION MADE: 18-DEC-01
P.O. BOX 529 510(k) SUMMARY AVAILABLE FROM FDA
LEECHBURG, PA 15656-0529
DEVICE: MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET
COOK, INC. 510(k) NO: K013916(TRADITIONAL)
ATTN: HEIDI MASTEN PHONE NO : 812-339-2235
925 SOUTH CURRY PIKE SE DECISION MADE: 20-DEC-01
P.O. BOX 489 510(k) SUMMARY AVAILABLE FROM FDA
BLOOMINGTON, IN 47402
DEVICE: CSIST DICOM GATEWAY/IMAGE MANAGER
CSIST 510(k) NO: K012327(TRADITIONAL)
ATTN: CARL ALLETO PHONE NO : 214-262-4209
1100 LAKEVIEW BLVD. SE DECISION MADE: 20-DEC-01
DENTION, TX 76208 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYBERMED, INC., V-WORKS
CYBERMED, INC. 510(k) NO: K013878(TRADITIONAL)
ATTN: GARY J ALLSEBROOK PHONE NO : 510-276-2648
16303 PANORAMIC WAY SE DECISION MADE: 07-DEC-01
SAN LEANDRO, CA 94578-1116 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MICROSCAN DRIED GRAM NEGATIVE OVERNIGHT MIC/COMBO PANELS
DADE MICROSCAN, INC. 510(k) NO: K013423(TRADITIONAL)
ATTN: CYNTHIA VAN DUKER PHONE NO : 916-374-3105
1584 ENTERPRISE BLVD. SE DECISION MADE: 12-DEC-01
WEST SACRAMENTO, CA 95691 510(k) STATEMENT
DEVICE: DATEX-OHMEDA S/5 NETWORK AND CENTRAL '01
DATEX-OHMEDA 510(k) NO: K013246(TRADITIONAL)
ATTN: JOEL KENT PHONE NO : 781-449-8685
86 PILGRIM ROAD SE DECISION MADE: 11-DEC-01
NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Z-NET
DEMITE LIMITED 510(k) NO: K001003(TRADITIONAL)
ATTN: WILLIAM H.E. VON OEHSEN PHONE NO : 202-347-0066
1001 PENNSYLVANIA AVE. SE DECISION MADE: 10-DEC-01
NW 6TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20004
DEVICE: CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT
DENKA SEIKEN'S 510(k) NO: K011958(TRADITIONAL)
ATTN: SEIYA SATO PHONE NO : 033 669 421
3-4-2 NIHONBASHI SE DECISION MADE: 04-DEC-01
KAYABACHO, CHUO-KU 510(k) SUMMARY AVAILABLE FROM FDA
TOKYO, JAPAN 103-0025
DEVICE: SUMMIT CEMENTED HIP PROSTHESIS
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K013352(TRADITIONAL)
ATTN: MARCIA J ARENTZ PHONE NO : 219-371-4944
700 ORTHOPAEDIC DR. SE DECISION MADE: 17-DEC-01
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: ACE BIO WIN TIBIAL NAILING SYSTEM
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K013430(TRADITIONAL)
ATTN: MARCIA J ARENTZ PHONE NO : 219-371-4944
700 ORTHOPAEDIC DR. SE DECISION MADE: 17-DEC-01
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LONG TROCHANTERIC NAIL SYSTEM
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K013563(TRADITIONAL)
ATTN: MARCIA J ARENTZ PHONE NO : 219-371-4944
700 ORTHOPAEDIC DR. SE DECISION MADE: 27-DEC-01
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DAYLITE XENON LIGHT SOURCES
DESIGNS FOR VISION, INC. 510(k) NO: K013880(TRADITIONAL)
ATTN: AMY GRUMET-AVALLONE PHONE NO : 631-585-3300
760 KOEHLER AVE. SE DECISION MADE: 07-DEC-01
RONKONKOMA, NY 11779 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DC-UIBC-CO2-CAL, MODEL SE-153
DIAGNOSTIC CHEMICALS LTD. 510(k) NO: K013178(TRADITIONAL)
ATTN: NANCY OLSCAMP PHONE NO : 902 566 1396
16 MCCARVILLE STREET SE DECISION MADE: 18-DEC-01
CHARLOTTETOWN, CANADA C1E 2A6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM
DIAMEDIX CORP. 510(k) NO: K013628(TRADITIONAL)
ATTN: LYNNE STIRLING PHONE NO : 305-324-2354
2140 NORTH MIAMI AVE. SE DECISION MADE: 21-DEC-01
MIAMI, FL 33127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STANDARD A, STANDARD B, STANDARD C, CAL, SLOPE
DIAMOND DIAGNOSTICS, INC. 510(k) NO: K013850(TRADITIONAL)
ATTN: LINDA M STUNDTNER PHONE NO : 508-429-0450
331 FISKE STREET SE DECISION MADE: 21-DEC-01
HOLLISTON, MA 01746 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO FIXION INTERLOCKING INTRAMEDULLARY NAILING SYSTE
DISC-O-TECH MEDICAL TECHNOLOGIES, 510(k) NO: K013449(TRADITIONAL)
ATTN: ELAD MAGAL PHONE NO : 972 9 9511511
3 HASADNAOT SE DECISION MADE: 19-DEC-01
HERZELIA, ISRAEL 46728 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRG ORTHOHEX SS BONE SCREW
DOCTOR'S RESEARCH GROUP, INC. 510(k) NO: K013786(TRADITIONAL)
ATTN: RICHARD DESLAURIERS PHONE NO : 860-283-1479
50 ALTAIR AVENUE SE DECISION MADE: 17-DEC-01
PLYMOUTH, CT 06782 510(k) STATEMENT
DEVICE: DXS DIGITAL X-RAY SYSTEM
DOUGLAS C. YOON, DDS 510(k) NO: K013271(TRADITIONAL)
ATTN: DOUGLAS C YOON PHONE NO : 310-702-3185
3940 LAUREL CANYON BLVD. #147 SE DECISION MADE: 13-DEC-01
STUDIO CITY, CA 91604 510(k) STATEMENT
DEVICE: OXYLOG 1000, MODEL 2M86840
DRAGER MEDIZINTECHNIK GMBH 510(k) NO: K010793(TRADITIONAL)
ATTN: JAMES J BRENNAN PHONE NO : 215-721-5400
3135 QUARRY ROAD SE DECISION MADE: 20-DEC-01
TELFORD, PA 18969 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NO STEP ON SITE DEUG TEST CUP
DRUG FREE ENTERPRISES 510(k) NO: K012390(TRADITIONAL)
ATTN: PERRY RUCKER PHONE NO : 310-415-7093
1627 S GRANVILLE AVE. SUITE 3 SE DECISION MADE: 18-DEC-01
WEST LOS ANGELES, CA 90025 510(k) STATEMENT
DEVICE: KODAK DIRECTVIEW TABLETOP CASSETTE
EASTMAN KODAK COMPANY 510(k) NO: K013686(SPECIAL)
ATTN: JUDITH A WALLACE PHONE NO : 716-724-6111
1669 LAKE AVE. SE DECISION MADE: 07-DEC-01
ROCHESTER, NY 14652 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO EBI XFIX DFS SYSTEM
EBI, L.P. 510(k) NO: K013739(SPECIAL)
ATTN: FREDERIC TESTA PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 13-DEC-01
PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO THE GRIP
ELCARE INNOVATIONS, INC. 510(k) NO: K010526(TRADITIONAL)
ATTN: ELROY T CANTRELL PHONE NO : 817-483-2310
7101 STEPHENSON-LEVEY RD SE DECISION MADE: 13-DEC-01
BURLESON, TX 76028 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO LEKSELL SURGIPLAN WITH ATLASPACE
ELEKTA INSTRUMENT AB 510(k) NO: K013861(SPECIAL)
ATTN: CAROL PATTERSON PHONE NO : 949-462-0900
21911 ERIE LANE SE DECISION MADE: 06-DEC-01
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLASMA SPRAYED SHOULDER
ENCORE ORTHOPEDICS, INC. 510(k) NO: K003324(TRADITIONAL)
ATTN: JOANNA DROEGE PHONE NO : 512-834-6255
9800 METRIC BLVD. SE DECISION MADE: 06-DEC-01
AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROMARK II TISSUE MARKER,MODEL C1535
ETHICON ENDO-SURGERY, INC. 510(k) NO: K013413(TRADITIONAL)
ATTN: GEORGIA C ABERNATHY PHONE NO : 513-337-3179
4545 CREEK RD. SE DECISION MADE: 03-DEC-01
CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INDIGO OPTIMA LASER SYSTEM
ETHICON ENDO-SURGERY, INC. 510(k) NO: K013493(TRADITIONAL)
ATTN: LINDA HILL PHONE NO : 513-337-7623
4545 CREEK ROAD SE DECISION MADE: 13-DEC-01
CINCINNATI, OH 45242 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT
EVENFLO COMPANY, INC. 510(k) NO: K013226(TRADITIONAL)
ATTN: MATTHEW G MCCARTY PHONE NO : 770-704-2000
1000 EVENFLO DRIVE SE DECISION MADE: 20-DEC-01
P.O. BOX 709 510(k) STATEMENT
CANTON, GA 30114
DEVICE: MODIFICATION TO: ACUMATCH L-SERIES BIPOLAR ENDOPROSTHESIS
EXACTECH, INC. 510(k) NO: K013211(SPECIAL)
ATTN: ROBERT PAXSON PHONE NO : 352-377-1140
2320 N.W. 66TH CT. SE DECISION MADE: 05-DEC-01
GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXCEL A.V FISUTAL NEEDLE SET
EXELINT INTL. CO. 510(k) NO: K013037(TRADITIONAL)
ATTN: ARMAND HAMID PHONE NO : 310-649-0707
5840 WEST CENTINELA AVE. SE DECISION MADE: 07-DEC-01
LOS ANGELES, CA 90045 510(k) STATEMENT
DEVICE: BI-3M NEEDLE-FREE INJECTOR SYSTEM
FELTON INTERNATIONAL, INC. 510(k) NO: K013256(TRADITIONAL)
ATTN: ALAN FELTON PHONE NO : 913-599-1590
8210 MARSHALL DRIVE SE DECISION MADE: 07-DEC-01
LENEXA, KS 66214 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ALPHA DX SYSTEM
FIRST MEDICAL, INC. 510(k) NO: K014024(SPECIAL)
ATTN: GREG HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 18-DEC-01
IRVINE, CA 92606 510(k) STATEMENT
DEVICE: OSPREY SPHERICAL AND TORIC MULTIFOCAL SOFT CONTACT LENSES
FLORIDA OPTICAL ENGINEERING, INC. 510(k) NO: K013445(TRADITIONAL)
ATTN: RICHARD A GRIFFIN PHONE NO : 386-472-2710
13709 PROGRESS BLVD., BOX 14 SE DECISION MADE: 26-DEC-01
ALACHUA, FL 32615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FOTONA DUALIS, FOTONA DUALIS PLUS
FOTONA D.D. 510(k) NO: K011939(TRADITIONAL)
ATTN: MOJCA VALJAVEC PHONE NO : 386 151 11215
STEGNE 7, SE DECISION MADE: 27-DEC-01
LJUBLJANA, SLOVENIA 1210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUJI SPEED SUITE, FUJI SPEED SUTE PHASE II
FUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K013218(ABBREVIATED)
ATTN: JOSEPH M AZARY PHONE NO : 203-327-6485
419 WEST AVE. SE DECISION MADE: 20-DEC-01
STAMFORD, CT 06902 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUKUDA DENSHI MODEL HG-500, PULSE OXIMETER MODULE
FUKUDA DENSHI USA, INC. 510(k) NO: K013273(TRADITIONAL)
ATTN: LARRY WALKER PHONE NO : 425-881-7737
17725 N.E. 65TH ST., BLDG. C SE DECISION MADE: 20-DEC-01
REDMOND, WA 98052-4911 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENTEGRA PE PERSONAL DIGITAL ASSISTANT
GENERAL ELECTRIC MEDICAL SYSTEMS 510(k) NO: K014058(TRADITIONAL)
ATTN: D. DUERSTELER PHONE NO : 262-317-9463
3000 NORTH GRANDVIEW BLVD. SE DECISION MADE: 21-DEC-01
WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES
GIMMI GMBH 510(k) NO: K012660(ABBREVIATED)
ATTN: DAGMAR MASER PHONE NO : 312 042 89591
AMSTEL 320-I SE DECISION MADE: 20-DEC-01
AMSTERDAM, NETHERLANDS 1017AP 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLUSITE, MODEL GLU002
GLUSTITCH, INC. 510(k) NO: K013446(TRADITIONAL)
ATTN: DON BLACKLOCK PHONE NO : 800 667 2130
#307 7188 PROGRESS WAY SE DECISION MADE: 20-DEC-01
DELTA, B.C., CANADA V4G 1M6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPANION MODEL 221, 321, 421
GOLDEN TECHNOLOGIES, INC. 510(k) NO: K012258(TRADITIONAL)
ATTN: FRED KIWAK PHONE NO : 570-451-7477
401 BRIDGE ST. SE DECISION MADE: 03-DEC-01
OLD FORGE, PA 18518 510(k) STATEMENT
DEVICE: HI-TOQUE WHISPER LS AND MS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC
GUIDANT CORP. 510(k) NO: K013092(TRADITIONAL)
ATTN: JENNIFER P RIGGS PHONE NO : 909-914-4581
26531 YNEZ RD. SE DECISION MADE: 13-DEC-01
TEMECULA, CA 92591-4628 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO VIKING OPTIMA GUIDING CATHETER
GUIDANT CORP. 510(k) NO: K013638(SPECIAL)
ATTN: NANCY E RALSTON PHONE NO : 909-914-6654
26531 YNEZ RD. SE DECISION MADE: 04-DEC-01
TEMECULA, CA 92591-4628 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOSPEED
H.S. HOSPITAL SERVICES S.P.A. 510(k) NO: K013069(TRADITIONAL)
ATTN: LUCIO IMPROTA PHONE NO : 561-477-1671
10147 UMBERLAND PLACE SE DECISION MADE: 12-DEC-01
BOCA RATON, FL 33428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JAMSHIDI BIOPSY NEEDLE
H.S. HOSPITAL SERVICES S.P.A. 510(k) NO: K013070(TRADITIONAL)
ATTN: LUCIO IMPROTA PHONE NO : 561-477-1671
10147 UMBERLAND PLACE SE DECISION MADE: 12-DEC-01
BOCA RATON, FL 33428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SECURCUT ASPIRATION BIOPSY NEEDLE
H.S. HOSPITAL SERVICES S.P.A. 510(k) NO: K013071(TRADITIONAL)
ATTN: LUCIO IMPROTA PHONE NO : 561-477-1671
10147 UMBERLAND PLACE SE DECISION MADE: 12-DEC-01
BOCA RATON, FL 33428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTRAMEDULLARY FIXATION SYSTEM FOR THE HAND
HAND INNOVATIONS, INC. 510(k) NO: K013424(TRADITIONAL)
ATTN: AL WEISENBORN PHONE NO : 305-829-3437
8905 SW 87TH AVENUE SE DECISION MADE: 20-DEC-01
MIAMI, FL 33176-2227 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343
HELENA LABORATORIES 510(k) NO: K013466(TRADITIONAL)
ATTN: PATRICIA FRANKS PHONE NO : 409-842-3714
P.O. BOX 752 SE DECISION MADE: 21-DEC-01
1530 LINDBERGH DRIVE 510(k) STATEMENT
BEAUMONT, TX 77794
DEVICE: ACUGLIDE BRAND ACUPUNCTURE NEEDLES
HELIO MEDICAL SUPPLIES, INC. 510(k) NO: K012583(TRADITIONAL)
ATTN: YI FEN CHANG PHONE NO : 408-433-3355
606 CHARCOT AVE. SE DECISION MADE: 11-DEC-01
SAN JOSE, CA 95131 510(k) STATEMENT
DEVICE: STRESS GUARD, MODEL HERDEV1
HERBO MEDEX INTERNATIONAL, INC. 510(k) NO: K004008(TRADITIONAL)
ATTN: RICHARD KEEN PHONE NO : 203-329-2700
1151 HOPE STREET SE DECISION MADE: 13-DEC-01
STAMFORD, CT 06907 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROGYN PLUS STIMULATION DEVICE
HOLLISTER, INC. 510(k) NO: K013141(TRADITIONAL)
ATTN: JOSEPH S TOKARZ PHONE NO : 847-680-2849
2000 HOLLISTER DR. SE DECISION MADE: 19-DEC-01
LIBERTYVILLE, IL 60048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM
HOWMEDICA OSTEONICS 510(k) NO: K013772(SPECIAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-825-4900
59 ROUTE 17 SE DECISION MADE: 03-DEC-01
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIDENT POROUS TITANIUM ACETABULAR COMPONENT WITH PERI-APATITE C
HOWMEDICA OSTEONICS CORP. 510(k) NO: K013475(TRADITIONAL)
ATTN: MARGARET F CROWE PHONE NO : 201-934-4359
59 ROUTE 17 SE DECISION MADE: 20-DEC-01
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIDENT HEMISPHERICAL ACETABULAR SHELLS
HOWMEDICA OSTEONICS CORP. 510(k) NO: K013676(SPECIAL)
ATTN: JENNIFER A DAUDELIN PHONE NO : 201-934-4354
59 ROUTE 17 SE DECISION MADE: 05-DEC-01
ALLENDALE, NJ 07070-2584 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO XIA SPINAL SYSTEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K013688(SPECIAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-825-4900
59 ROUTE 17 SE DECISION MADE: 05-DEC-01
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XIA SPINAL SYSTEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K013823(SPECIAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-760-8187
59 ROUTE 17 SE DECISION MADE: 19-DEC-01
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGICAP
HUMANA USA, INC. 510(k) NO: K012199(TRADITIONAL)
ATTN: H.N. DUNNING PHONE NO : 301-229-2138
8309 BRYANT DRIVE SE DECISION MADE: 19-DEC-01
BETHESDA, MD 20817 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: H.M.T. ACUPUNCTURE NEEDLE
HUMMINGBIRD MEDICAL TECHNOLOGY, L.510(k) NO: K012501(TRADITIONAL)
ATTN: GEOFFREY HSU PHONE NO : 214-284-5433
1427 GREENBRIAR DR. SE DECISION MADE: 11-DEC-01
ALLEN, TX 75013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ICS MEDICAL MODEL VG-30 VIDEO GOGGLES
ICS MEDICAL 510(k) NO: K013060(TRADITIONAL)
ATTN: ROBERT M SIMENSON PHONE NO : 800-289-2150
125 COMMERCE DR. SE DECISION MADE: 10-DEC-01
SCHAUMBURG, IL 60173-5329 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM
IMAGYN MEDICAL TECHNOLOGIES, INC. 510(k) NO: K010166(TRADITIONAL)
ATTN: JULIE POWELL PHONE NO : 616-629-2787
8850 M-89 SE DECISION MADE: 03-DEC-01
RICHLAND, MI 49083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSSEOTITE DENTAL IMPLANTS
IMPLANT INNOVATIONS, INC. 510(k) NO: K013570(SPECIAL)
ATTN: JACQUELYN A HUGHES PHONE NO : 561-776-6819
4555 RIVERSIDE DR. SE DECISION MADE: 17-DEC-01
PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOME-AWAY SYSTEM
IN-X CORP. 510(k) NO: K004047(TRADITIONAL)
ATTN: CHARLIE HENRY PHONE NO : 303-574-3115
6753 EAST 47TH AVENUE SE DECISION MADE: 18-DEC-01
UNIT D 510(k) SUMMARY AVAILABLE FROM FDA
DENVER, CO 80216
DEVICE: LATEX EXAMINATION GLOVES POWDERFREE POLYMER COATED WITH PROTEIN
INNOVATIVE GLOVES CO; LTD 510(k) NO: K013333(TRADITIONAL)
ATTN: RAJEEV K SOOD PHONE NO : 661 897 9821
11 CHOTEVITTAYAKUL 3 RD. SE DECISION MADE: 07-DEC-01
HATYAI, SONGKHLA, THAILAND 510(k) STATEMENT
DEVICE: INVACARE ELEVATING SEAT OPTION ESS6
INVACARE CORP. 510(k) NO: K013516(TRADITIONAL)
ATTN: RAE A FARROW PHONE NO : 440-329-6356
ONE INVACARE WAY SE DECISION MADE: 13-DEC-01
P.O. BOX 4028 510(k) SUMMARY AVAILABLE FROM FDA
ELYRIA, OH 44036-2125
DEVICE: MEDIGROUP KEY TUBE
JANIN GROUP, INC. 510(k) NO: K013017(TRADITIONAL)
ATTN: JOHN A NAVIS PHONE NO : 630-428-4143
505 WESTON RIDGE DR. SE DECISION MADE: 06-DEC-01
NAPERVILLE, IL 60563-3932 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AST (SGOT)
JAS DIAGNOSTIC, INC. 510(k) NO: K013698(TRADITIONAL)
ATTN: DAVID JOHNSTON PHONE NO : 305-418-2320
7220 NW 58TH ST. SE DECISION MADE: 21-DEC-01
MIAMI, FL 33166 510(k) STATEMENT
DEVICE: JOSTRA FLOWPROBE FP-32E
JOSTRA AG 510(k) NO: K013939(TRADITIONAL)
ATTN: KATHLEEN JOHNSON PHONE NO : 610-932-7738
478 MEDIA ROAD SE DECISION MADE: 14-DEC-01
OXFORD, PA 19363 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-
K-SYSTEMS, KIVEX BIOTEC LTD. 510(k) NO: K013401(TRADITIONAL)
ATTN: JACOB MOLLENBACH PHONE NO : 454 599 5600
KLINTEHOJ VAENGE 21 SE DECISION MADE: 14-DEC-01
BIRKEROD, DENMARK DA-3460 510(k) STATEMENT
DEVICE: KIMSTIM AURICULAR ELECTRODE
KIM INSTITUTE FOR REHABILITATION M510(k) NO: K011691(TRADITIONAL)
ATTN: DONALD F GRABARZ PHONE NO : 801-233-0075
7651 S. 700 WEST SE DECISION MADE: 27-DEC-01
SUITE 105 510(k) STATEMENT
SALT LAKE CITY, UT 84047
DEVICE: ROYAL IMPERIAL POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CO
KOON SENG SDN.BHD 510(k) NO: K013537(TRADITIONAL)
ATTN: LIM WENG HENG PHONE NO : 606 986 8446
PTD 3274 BATU 4 1/2 SE DECISION MADE: 07-DEC-01
JALAN BAKRI 510(k) STATEMENT
MUAR JOHOR, MALAYSIA 84200
DEVICE: LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS "POCKETP
LARES RESEARCH, INC. 510(k) NO: K011960(TRADITIONAL)
ATTN: THOMAS H LOUISELL PHONE NO : 530-345-1767
295 LOCKHEED AVE. SE DECISION MADE: 21-DEC-01
CHICO, CA 95973 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRE-LOADED ULTRAFIX RC
LINVATEC CORP. 510(k) NO: K013553(TRADITIONAL)
ATTN: LAURA D SENEFF PHONE NO : 727-399-5234
11311 CONCEPT BLVD. SE DECISION MADE: 19-DEC-01
LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIGHTSHEER UV-B PHOTOTHERAPY EQUIPMENT
LUMENIS 510(k) NO: K011197(TRADITIONAL)
ATTN: C. ROBERT PAYNE JR. PHONE NO : 925-249-8034
1249 QUARRY LANE SE DECISION MADE: 14-DEC-01
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
PLEASANTON, CA 94566-3403
DEVICE: MACROPORE TS ANTI-ADHESION FILM
MACROPORE, INC. 510(k) NO: K012025(TRADITIONAL)
ATTN: KENNETH K KLEINHENZ PHONE NO : 858-458-0900
6740 TOP GUN ST. SE DECISION MADE: 03-DEC-01
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KNIGHTSTAR 330 VENTILATOR
MALLINCKRODT, INC. 510(k) NO: K003075(TRADITIONAL)
ATTN: ANTHONY MULLIN PHONE NO : 314-645-3049
675 MCDONNELL BLVD. SE DECISION MADE: 11-DEC-01
BLDG. 10-2-N 510(k) SUMMARY AVAILABLE FROM FDA
ST. LOUIS, MO 63134
DEVICE: MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE
MASIMO CORP. 510(k) NO: K013792(SPECIAL)
ATTN: JAMES J CRONIN PHONE NO : 949-250-9688
2852 KELVIN AVE. SE DECISION MADE: 11-DEC-01
IRVINE, CA 92614-5826 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MASTER & FRANK SURGICAL GOWNS (STERILE)
MASTER & FRANK ENT. CO., LTD. 510(k) NO: K012186(TRADITIONAL)
ATTN: JENNIFER REICH PHONE NO : 928-773-9488
3892 SOUTH AMERICA WEST TRAIL SE DECISION MADE: 07-DEC-01
FLAGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MILLCOMP
MATH RESOLUTIONS, LLC. 510(k) NO: K011845(TRADITIONAL)
ATTN: WENDEL DEAN RENNER PHONE NO : 410-997-9578
5975 GALES LANE SE DECISION MADE: 04-DEC-01
COLUMBIA, MD 21045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE
MED GEN, INC. 510(k) NO: K013244(TRADITIONAL)
ATTN: THEDORE BARASH PHONE NO : 561-750-1100
7284 W. PALMETTO PK. RD. SE DECISION MADE: 07-DEC-01
BOCA RATON, FL 33433-3406 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSTACLOT FOR OTC USE, TRAUMASSTAT FOR PRESCRIPTION USE
MEDAFOR, INC. 510(k) NO: K013225(TRADITIONAL)
ATTN: PHILIP B JARVI PHONE NO : 763-571-6300
5201 EAST RIVER ROAD, # 312 SE DECISION MADE: 26-DEC-01
MINNEAPOLIS, MN 55421-1035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAS LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL 1 AND 2,
MEDICAL ANALYSIS SYSTEMS, INC. 510(k) NO: K013734(SPECIAL)
ATTN: PENNY M LAYMAN PHONE NO : 805-987-7891
5300 ADOLFO RD. SE DECISION MADE: 07-DEC-01
CAMARILLO, CA 93012 510(k) STATEMENT
DEVICE: MODIFICATION TO MAS CARDIOLMMUNE TL; DADE CARDIAC TL
MEDICAL ANALYSIS SYSTEMS, INC. 510(k) NO: K013995(TRADITIONAL)
ATTN: PENNY M LAYMAN PHONE NO : 805-987-7891
5300 ADOLFO RD. SE DECISION MADE: 21-DEC-01
CAMARILLO, CA 93012 510(k) STATEMENT
DEVICE: KIMAX REMOTE VIEWING STATION
MEDICAL METRICS, INC. 510(k) NO: K013098(TRADITIONAL)
ATTN: ANN TUNSTALL PHONE NO : 301-652-6739
4600 NORTH PARK AVE. SE DECISION MADE: 07-DEC-01
SUITE 100 510(k) STATEMENT
CHEVY CHASE, MD 20815-4518
DEVICE: MSI BIPOLAR SHEATH
MEDICAL SCIENTIFIC, INC. 510(k) NO: K011202(TRADITIONAL)
ATTN: PAUL NARDELLA PHONE NO : 508-880-7313
125 JOHN HANCOCK RD. SE DECISION MADE: 31-DEC-01
TAUNTON, MA 02780 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDLINE EXCEL RECLINCER WHEELCHAIR
MEDLINE INDUSTRIES, INC. 510(k) NO: K013761(TRADITIONAL)
ATTN: ANDREA HAFERKAMP PHONE NO : 847-837-2759
ONE MEDLINE PL. SE DECISION MADE: 06-DEC-01
MUNDELEIN, IL 60060-4486 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDRAD QWIK-FIT SYRINGE
MEDRAD, INC. 510(k) NO: K013815(SPECIAL)
ATTN: FRANK W PELC III PHONE NO : 412-767-2400
ONE MEDRAD DR. SE DECISION MADE: 13-DEC-01
INDIANOLA, PA 15051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR.
MEDTRONIC CARDIAC SURGICAL PRODUCT510(k) NO: K013013(TRADITIONAL)
ATTN: ROGER W BRINK PHONE NO : 616-643-7337
620 WATSON SW SE DECISION MADE: 04-DEC-01
GRAND RAPIDS, MI 49504-6393 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GRIP LOCK ANCHOR, MODEL 411374
MEDTRONIC NEUROLOGICAL 510(k) NO: K013063(TRADITIONAL)
ATTN: MONAYA LEE PHONE NO : 763-514-5068
800 53RD AVE., N.E. SE DECISION MADE: 11-DEC-01
P.O. BOX 1250 510(k) SUMMARY AVAILABLE FROM FDA
MINNEAPOLIS, MN 55421
DEVICE: MEDTRONIC INVISX BURR HOLE LOCK, MODEL 60520
MEDTRONIC NEUROSURGERY 510(k) NO: K013000(TRADITIONAL)
ATTN: JANET MCAULEY PHONE NO : 805-968-1546
125 CREMONA DR., SE DECISION MADE: 05-DEC-01
UNIVERSITY BUSINESS CENTER 510(k) SUMMARY AVAILABLE FROM FDA
GOLETA, CA 93117
DEVICE: LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATOR
MEDTRONIC PHYSIO-CONTROL CORP. 510(k) NO: K011144(TRADITIONAL)
ATTN: SHERRI L POCOCK PHONE NO : 425-867-4332
11811 WILLOWS RD NE BX 97006 SE DECISION MADE: 03-DEC-01
REDMOND, WA 98073-9706 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPINAL MESH SYSTEM
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K011406(TRADITIONAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PL. SE DECISION MADE: 27-DEC-01
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEMENT RESTRICTOR
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K013663(SPECIAL)
ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PL. SE DECISION MADE: 05-DEC-01
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTE
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K013829(SPECIAL)
ATTN: RICK W TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 19-DEC-01
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO TSRH SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K014076(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PL. SE DECISION MADE: 27-DEC-01
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MENTOR CONTOUR PROFILE TISSUE EXPANDER
MENTOR CORP. 510(k) NO: K011500(TRADITIONAL)
ATTN: DONNA CRAWFORD PHONE NO : 805-879-6304
201 MENTOR DRIVE SE DECISION MADE: 03-DEC-01
SANTA BARBARA, CA 93111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 5
MERITS HEALTH PRODUCTS CO., LTD. 510(k) NO: K013788(SPECIAL)
ATTN: WINSTON ANDERSON PHONE NO : 800-963-7487
P.O. BOX 150356 SE DECISION MADE: 11-DEC-01
CAPE CORAL, FL 33915 510(k) STATEMENT
DEVICE: AUROFLUID PLUS
METALOR TECHNOLOGIES USA 510(k) NO: K013505(TRADITIONAL)
ATTN: BRUCE BARTON PHONE NO : 800-554-5504
255 JOHN L. DIETSCH BLVD. SE DECISION MADE: 19-DEC-01
NORTH ATTLEBOROUGH, MA 02761 510(k) STATEMENT
DEVICE: CTXA HIP; CTXA; QCT PRO CTXA HIP
MINDWAYS SOFTWARE, INC. 510(k) NO: K002113(TRADITIONAL)
ATTN: CHRISTOPHER CANN PHONE NO : 415-247-9930
282 SECOND ST., 4TH FL. SE DECISION MADE: 04-DEC-01
SAN FRANCISCO, CA 94105-3130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIGHT SABER INTRODUCER NEEDLE
MINRAD, INC. 510(k) NO: K013040(TRADITIONAL)
ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5600
555 THIRDTEENTH ST., NW SE DECISION MADE: 07-DEC-01
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FOTONA DUALIS ND:YAG LASER SYSTEM, FOTONA TWINLIGHT ND:YAG LASER
MOJCA VALIJAVEC 510(k) NO: K013047(TRADITIONAL)
ATTN: MOJCA VALJAVEC PHONE NO :
FONTONA D.D SE DECISION MADE: 06-DEC-01
STEGNE 7 510(k) SUMMARY AVAILABLE FROM FDA
LJUBLIJANA, SLOVENIA 1210
DEVICE: NASTECH MAMMARY ASPIRATION SPECIMAN CYTOLOGY TEST MASCT
NASTECH PHARMACEUTICAL COMPANY, IN510(k) NO: K012088(TRADITIONAL)
ATTN: PETER C APRILE PHONE NO : 631-273-0101
45 ADAMS AVE. SE DECISION MADE: 18-DEC-01
HAUPPAUGE, NY 11788-3605 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SELECTIVA GUIDEWIRE
NEO METRICS, INC. 510(k) NO: K013024(TRADITIONAL)
ATTN: GENE CHAMPEAU PHONE NO : 763-559-4440
15301 HIGHWAY 55 WEST SE DECISION MADE: 04-DEC-01
MINNEAPOLIS, MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMO
NICHOLS INSTITUTE DIAGNOSTICS 510(k) NO: K013992(TRADITIONAL)
ATTN: ROBERT SCHMIDT PHONE NO : 949-240-5417
33051 CALLE AVIADOR SE DECISION MADE: 13-DEC-01
SAN JUAN CAPISTRANO, CA 92675 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM
NICOLET VASCULAR, INC. 510(k) NO: K013419(TRADITIONAL)
ATTN: DAVID W WAGNER PHONE NO : 303-431-9400
6355 JOYCE DR. SE DECISION MADE: 20-DEC-01
GOLDEN, CO 80403 510(k) STATEMENT
DEVICE: NIPRO SAFELET CATH
NIPRO MEDICAL CORP. 510(k) NO: K013287(TRADITIONAL)
ATTN: KAELYN B HADLEY PHONE NO : 859-224-8256
1384 COPPERFIELD COURT SE DECISION MADE: 03-DEC-01
LEXINGTON, KY 40514 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIPRO HYPODERMIC NEEDLE
NIPRO MEDICAL CORP. 510(k) NO: K013293(TRADITIONAL)
ATTN: KAELYN B HADLEY PHONE NO : 859-224-8256
1384 COPPERFIELD COURT SE DECISION MADE: 14-DEC-01
LEXINGTON, KY 40514 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOMOS MOTORIZED CRANE II
NOMOS CORP. 510(k) NO: K013036(TRADITIONAL)
ATTN: FRANCIS X DOBSCHA PHONE NO : 724-934-8242
2591 WEXFORD BAYNE RD., #400 SE DECISION MADE: 07-DEC-01
SEWICKLEY, PA 15143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NORMATEC PCD
NORMATEC, INC. 510(k) NO: K013436(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIREENTH STREET SE DECISION MADE: 21-DEC-01
WASHINGTON, DC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOMEDICS UV COLORS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LEN
OCULAR SCIENCES PUERTO RICO, INC. 510(k) NO: K013377(TRADITIONAL)
ATTN: RICHARD LIPPMAN PHONE NO : 301-770-9590
12300 TWINBROOK PARKWAY SE DECISION MADE: 20-DEC-01
SUITE 625 510(k) SUMMARY AVAILABLE FROM FDA
ROCKVILLE, MD 20852
DEVICE: POLESTAR N-10
ODIN MEDICAL TECHNOLOGIES LTD. 510(k) NO: K010850(TRADITIONAL)
ATTN: ADI ICKOWICZ PHONE NO : 972 495 91010
P.O. BOX 248 SE DECISION MADE: 17-DEC-01
YOKNEAM ELIT, ISRAEL 20692 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONDREX P.A.L. SYSTEM
OHMEDA MEDICAL 510(k) NO: K010388(TRADITIONAL)
ATTN: ALBERTO F PROFUMO PHONE NO : 410-888-5204
8880 GORMAN RD. SE DECISION MADE: 11-DEC-01
LAUREL, MD 20723 510(k) STATEMENT
DEVICE: HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE
OLYMPUS AMERICA, INC. 510(k) NO: K013066(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688
2 CORPORATE CENTER DR. SE DECISION MADE: 11-DEC-01
MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XENF-TP RHINO-LARYNGOFIBERSCOPE, ITS ACESSORIES AND ANCILLARY EQ
OLYMPUS OPTICAL CO., LTD. 510(k) NO: K013591(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688
TWO CORPORATE CENTER DRIVE SE DECISION MADE: 26-DEC-01
MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANISEIKONIA INSPECTOR
OPTICAL DIAGNOSTICS, INC. 510(k) NO: K013110(TRADITIONAL)
ATTN: JOYCE DE WIT PHONE NO : 425-391-9259
490 MT. FURY CIRCLE SW SE DECISION MADE: 19-DEC-01
ISSAQUAH, WA 98027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS
ORTHO-CLINICAL DIAGNOSTICS 510(k) NO: K013900(TRADITIONAL)
ATTN: MARLENE A SHULMAN PHONE NO : 716-453-4041
100 INDIGO CREEK DRIVE SE DECISION MADE: 21-DEC-01
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVALON CUP SYSTEM
ORTHOPEDIC SOURCE INC. 510(k) NO: K011887(TRADITIONAL)
ATTN: STEVEN L MANDELL PHONE NO : 800-500-0381
PO BOX 307 SE DECISION MADE: 27-DEC-01
LOOMIS, CA 95650 510(k) STATEMENT
DEVICE: ORTHOSONIX ENERGEX
ORTHOSONIX, INC. 510(k) NO: K013094(TRADITIONAL)
ATTN: RUSSELL PAGANO PHONE NO : 202-546-1266
615 7TH STREET NE SE DECISION MADE: 14-DEC-01
1ST FLOOR 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20002
DEVICE: MJS POSTERIOR STABILIZED KNEE SYSTEM
OSTEOIMPLANT TECHNOLOGY, INC. 510(k) NO: K012762(TRADITIONAL)
ATTN: SAM SON PHONE NO : 410-785-0700
11201 PEPPER RD. SE DECISION MADE: 11-DEC-01
HUNT VALLEY, MD 21031-1201 510(k) STATEMENT
DEVICE: UBIT-IR300 INFRARED SPECTROMETRY SYSTEM
OTSUKA PHARMACEUTICAL CO., LTD. 510(k) NO: K013371(TRADITIONAL)
ATTN: CYNTHIA A SINCLAIR PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 21-DEC-01
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OXOID PYLORI TEST KIT, MODEL DR0130M
OXOID, LTD. 510(k) NO: K012588(TRADITIONAL)
ATTN: ANDY HOLLINGSWORTH PHONE NO : 441 125 6841144
WADE ROAD SE DECISION MADE: 10-DEC-01
BASINGSTOKE,HANTS, UNITED KINGDOM 510(k) STATEMENT
DEVICE: PALOMAR SLP 1000
PALOMAR MEDICAL PRODUCTS, INC. 510(k) NO: K013028(TRADITIONAL)
ATTN: MARCY MOORE PHONE NO : 919-363-2432
131 KELEKENT LANE SE DECISION MADE: 06-DEC-01
CARY, NC 27511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE
PERCLOSE, INC. 510(k) NO: K013683(SPECIAL)
ATTN: PATTY HEVEY PHONE NO : 650-474-3202
400 SAGINAW SE DECISION MADE: 06-DEC-01
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AT HOME DRUG TEST, MODEL 9084
PHAMATECH INC. 510(k) NO: K013407(SPECIAL)
ATTN: CARL MONGIOVI PHONE NO : 858-635-5840
9530 PADGETT ST., #101-106 SE DECISION MADE: 06-DEC-01
SAN DIEGO, CA 92126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AT HOME DRUG TEST, MODEL 9079
PHAMATECH INC. 510(k) NO: K013408(SPECIAL)
ATTN: CARL MONGIOVI PHONE NO : 858-635-5840
9530 PADGETT ST., #101 SE DECISION MADE: 06-DEC-01
SAN DIEGO, CA 92126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AT HOME DRUG TEST, MODEL 9074
PHAMATECH INC. 510(k) NO: K013409(SPECIAL)
ATTN: CARL MONGIOVI PHONE NO : 858-635-5840
9530 PADGETT ST., #101 SE DECISION MADE: 06-DEC-01
SAN DIEGO, CA 92126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AT HOME DRUG TEST, MODEL 9064
PHAMATECH INC. 510(k) NO: K013410(SPECIAL)
ATTN: CARL MONGIOVI PHONE NO : 858-635-5840
9530 PADGETT ST., #101 SE DECISION MADE: 06-DEC-01
SAN DIEGO, CA 92126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AT HOME DRUG TEST, MODEL 9069
PHAMATECH INC. 510(k) NO: K013412(SPECIAL)
ATTN: CARL MONGIOVI PHONE NO : 858-635-5840
9530 PADGETT ST., #101 SE DECISION MADE: 06-DEC-01
SAN DIEGO, CA 92126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERA I/T
PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K013344(TRADITIONAL)
ATTN: PETER ALTMAN PHONE NO : 203-926-7031
472 WHEELERS FARMS ROAD SE DECISION MADE: 11-DEC-01
MILFORD, CT 06460 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO AGILENT COMPONENT MONITORING SYSTEM (CMS), V24/V
PHILIPS MEDIZINSYSTEME BOBLINGEN G510(k) NO: K013624(SPECIAL)
ATTN: DENISE HALEY PHONE NO : 978-687-1501
3000 MINUTEMAN ROAD SE DECISION MADE: 03-DEC-01
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES
PHOENIX DIAGNOSTICS, INC. 510(k) NO: K013451(TRADITIONAL)
ATTN: RAM NUNNA PHONE NO : 508-655-8310
8 TECH CIRCLE SE DECISION MADE: 18-DEC-01
NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RT-PLUS KNEE ADDITIONAL COMPONENTS
PLUS ORTHOPEDICS 510(k) NO: K013340(SPECIAL)
ATTN: HARTMUT LOCH PHONE NO : 888-741-7587
6055 LUSK BLVD. SE DECISION MADE: 20-DEC-01
SAN DIEGO, CA 92121-2700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOSCANNER PLUS
POLYMER TECHNOLOGY SYSTEMS, INC. 510(k) NO: K014099(SPECIAL)
ATTN: MARGO ENRIGHT PHONE NO : 317-870-5610
7736 ZIONSVILLE RD. SE DECISION MADE: 21-DEC-01
INDIANAPOLIS, IN 46268 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDPOR COATED TEAR DRAIN
POREX SURGICAL, INC. 510(k) NO: K012108(TRADITIONAL)
ATTN: HOWARD MERCER PHONE NO : 678-479-1610
15 DART RD. SE DECISION MADE: 19-DEC-01
NEWNAN, GA 30265 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL
POREX SURGICAL, INC. 510(k) NO: K012350(TRADITIONAL)
ATTN: HOWARD MERCER PHONE NO : 678-479-1610
15 DART RD. SE DECISION MADE: 05-DEC-01
NEWNAN, GA 30265 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP
PORGES S.A. 510(k) NO: K013172(ABBREVIATED)
ATTN: BERNARD ISMAEL PHONE NO : 331 460 13232
CENTRE D'AFFAIRES SE DECISION MADE: 20-DEC-01
LA BOURSIDIERE 510(k) SUMMARY AVAILABLE FROM FDA
LE PLESSIS ROBINSON CEDEX, FRANCE
DEVICE: REFERENCE CHECK, CATALOG NUMBER-RCN-10
PRECISION BIOLOGIC 510(k) NO: K013708(TRADITIONAL)
ATTN: STEPHEN L DUFF PHONE NO : 902 468 6422
900 WINDMILL RD., SUITE 100 SE DECISION MADE: 10-DEC-01
DARTMOUTH, N.S., CANADA B3B 1P7 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PULPDENT CAVITY PREPARATION IV
PULPDENT CORP. 510(k) NO: K013411(TRADITIONAL)
ATTN: KENNETH J BERK PHONE NO : 617-926-6666
80 OAKLAND ST. SE DECISION MADE: 12-DEC-01
P.O. BOX 780 510(k) SUMMARY AVAILABLE FROM FDA
WATERTOWN, MA 02471-0780
DEVICE: DYNAPULSE 5000A MINI ABP BLOOD PRESSURE MONITORING SYSTEM
PULSE METRIC, INC. 510(k) NO: K013358(SPECIAL)
ATTN: ROBERT DUFFY PHONE NO : 858-480-1171
11777 SORRENTO VALLEY ROAD SE DECISION MADE: 13-DEC-01
SAN DIEGO, CA 92121 510(k) STATEMENT
DEVICE: RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MOD
RADI MEDICAL SYSTEMS AB 510(k) NO: K013943(SPECIAL)
ATTN: MATS GRANLUND PHONE NO : 461 816 1000
PALMBLADSGATAN 10 SE DECISION MADE: 18-DEC-01
UPPSALA, SWEDEN S-754 50 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENETRA
RADIOMED CORPORATION 510(k) NO: K013660(SPECIAL)
ATTN: GORDON ROBERTS PHONE NO : 978-649-0300
ONE INDUSTRIAL WAY SE DECISION MADE: 05-DEC-01
TYNGSBORO, MA 01879-1400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XPLAN 2.2 WITH THE BODY SYSTEM
RADIONICS, A DIVISION OF TYCO HEAL510(k) NO: K013661(SPECIAL)
ATTN: KEVIN J O'CONNELL PHONE NO : 781-272-1233
22 TERRY AVE. SE DECISION MADE: 03-DEC-01
BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RANDOX PHENYTOIN
RANDOX LABORATORIES, LTD. 510(k) NO: K011393(TRADITIONAL)
ATTN: P. ARMSTRONG PHONE NO : 44 289 4422413
55 DIAMOND RD. SE DECISION MADE: 04-DEC-01
CRUMLIN, CO. ANTRIM, IRELAND BT29 510(k) STATEMENT
DEVICE: REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600
REMINGTON PRODUCTS COMPANY, L.L.C.510(k) NO: K013328(TRADITIONAL)
ATTN: PAMELA J FURMAN PHONE NO : 202-789-1212
1400 SIXTEENTH ST. N.W. SE DECISION MADE: 03-DEC-01
SUITE 400 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20036
DEVICE: RENMED CONTAMI-SHIELD BREATHING CIRCUIT SLEEVE, MODEL 9999/01
RENNELS MEDICAL CORP. 510(k) NO: K013200(TRADITIONAL)
ATTN: DAVID LEE PHONE NO : 828-437-1085
PO BOX 3626 SE DECISION MADE: 14-DEC-01
MORGANTON, NC 28680-3626 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MISTER NEB NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS123
RESPIRONICS HEALTHSCAN, INC. 510(k) NO: K013027(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001
55 NORTHERN BLVD., SE DECISION MADE: 06-DEC-01
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021 THIRD PARTY REVIEW
DEVICE: BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM
RESPIRONICS, INC. 510(k) NO: K012323(SPECIAL)
ATTN: DAVID J VANELLA PHONE NO : 724-733-5866
1001 MURRY RIDGE LANE SE DECISION MADE: 20-DEC-01
MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAMP MYOGLOBIN ASSAY
RESPONSE BIOMEDICAL CORP. 510(k) NO: K012040(TRADITIONAL)
ATTN: WILLIAM J RADVAK PHONE NO : 604 681 4101
8855 NORTHBROOK COURT SE DECISION MADE: 18-DEC-01
BURNABY, BRITISH COLUMBIA, CANADA 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIOCOLLECT PORTABLE ELECTROCARDIOGRAPH
REYNOLDS MEDICAL LTD. 510(k) NO: K013367(TRADITIONAL)
ATTN: GEORGE MYERS PHONE NO : 201-727-1703
377 RT. 17 S. SE DECISION MADE: 13-DEC-01
HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: METAPAK MULTI-PURPOSE INSTRUMENT TRAY
RILEY MEDICAL, INC. 510(k) NO: K993535(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 07-DEC-01
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCU-CHEK ACTIVE TEST SYSTEM
ROCHE DIAGNOSTICS CORP. 510(k) NO: K012324(TRADITIONAL)
ATTN: MIKE FLIS PHONE NO : 800-428-5074
9115 HAGUE ROAD SE DECISION MADE: 05-DEC-01
P.O. BOX 50457 510(k) SUMMARY AVAILABLE FROM FDA
INDIANAPOLIS, IN 46250-0457
DEVICE: ABUSCREEN ONLINE OPIATES 300 / 2000
ROCHE DIAGNOSTICS CORP. 510(k) NO: K013482(TRADITIONAL)
ATTN: KERWIN KAUFMAN PHONE NO : 317-521-7637
9115 HAGUE RD. SE DECISION MADE: 21-DEC-01
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAS STREPALERT
SA SCIENTIFIC, INC. 510(k) NO: K013379(TRADITIONAL)
ATTN: RICARDO R MARTINEZ PHONE NO : 210-699-8800
4919 GOLDEN QUAIL SE DECISION MADE: 12-DEC-01
SAN ANTONIO, TX 78240 510(k) STATEMENT
DEVICE: ULTRASAFE DENTAL INJECTION SYSTEM
SAFETY SYRINGES, INC. 510(k) NO: K013801(SPECIAL)
ATTN: THOMAS L HALL PHONE NO : 760-918-9908
1939 PALOMAR OAKS WAY, SUITE A SE DECISION MADE: 13-DEC-01
CARLSBAD, CA 92009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-010
SALIMETRICS LLC. 510(k) NO: K011323(TRADITIONAL)
ATTN: EVE SCHWARTZ PHONE NO : 814-234-7748
101 INNOVATION BLVD. SE DECISION MADE: 17-DEC-01
SUITE 302 510(k) SUMMARY AVAILABLE FROM FDA
STATE COLLEGE, PA 16803
DEVICE: SANYO CO2 INCUBATORS, MODELS NOS. MCO-17AC, MCO-17AIC, MCO-20AIC
SANYO NORTH AMERICA CORP. 510(k) NO: K013703(TRADITIONAL)
ATTN: SACHI KATAOKA PHONE NO : 630-875-3536
900 N. ARLINGTON HEIGHTS RD SE DECISION MADE: 14-DEC-01
SUITE 310 510(k) SUMMARY AVAILABLE FROM FDA
TASCA, IL 60143-2844
DEVICE: SAUFLON MULTI LENS CARE SYSTEM
SAUFLON PHARMACEUTICALS, LTD. 510(k) NO: K010559(TRADITIONAL)
ATTN: LIGIA DELACRUZ PHONE NO : 440 208 3224200
49-53 YORK ST. SE DECISION MADE: 20-DEC-01
TWICKENHAM, MIDDLESEX, UNITED KING510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS
SAUFLON PHARMACEUTICALS, LTD. 510(k) NO: K013649(TRADITIONAL)
ATTN: LIGIA DELACRUZ PHONE NO : 442 083 224200
49-53 YORK ST. SE DECISION MADE: 26-DEC-01
TWICKENHAM, MIDDLESEX, UNITED KING510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NON-STERILE POWDER FREE GREEN LATEX EXAMINATION GLOVES WITH ALOE
SGMP CO., LTD. 510(k) NO: K013288(TRADITIONAL)
ATTN: JANNA TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 03-DEC-01
SPARKS, NV 89434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CTS-415
SHANTOU INSTITUTE OF ULTRASONIC IN510(k) NO: K013327(TRADITIONAL)
ATTN: BOB LEIKER PHONE NO : 925-556-1619
1106 CHILTERN DRIVE SE DECISION MADE: 14-DEC-01
WALNUT CREEK, CA 94596 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E
SIEMENS ELEMA AB 510(k) NO: K010925(ABBREVIATED)
ATTN: DIANE WURZBURGER PHONE NO : 732-321-4765
MEDICAL SOLUTIONS SE DECISION MADE: 18-DEC-01
186 WOOD AVENUE SOUTH 510(k) SUMMARY AVAILABLE FROM FDA
ISELIN, NJ 08830-2770
DEVICE: MAGNETOM TRIO SYSTEM
SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K013586(TRADITIONAL)
ATTN: JAMIE YIEH PHONE NO : 732-321-4625
186 WOOD AVENUE SOUTH SE DECISION MADE: 28-DEC-01
ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971
SIGMA DIAGNOSTICS, INC. 510(k) NO: K013549(TRADITIONAL)
ATTN: WILLIAM R GILBERT II PHONE NO : 314-286-6693
545 SOUTH EWING AVE. SE DECISION MADE: 26-DEC-01
ST. LOUIS, MO 63103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM
SIMS LEVEL 1, INC. 510(k) NO: K011907(TRADITIONAL)
ATTN: GABRIEL J MURACA, JR. PHONE NO : 781-878-8011
160 WEYMOUTH ST. SE DECISION MADE: 18-DEC-01
ROCKLAND, MA 02370 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GELCLAIR CONCENTRATED ORAL GEL
SINCLAIR PHARMACEUTICALS, LTD. 510(k) NO: K013056(TRADITIONAL)
ATTN: PRISCILLA COX PHONE NO : 44 166 3750410
1 ALDER BROOK SE DECISION MADE: 21-DEC-01
CHINLEY, HIGH PEAK, UNITED KINGDOM510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHOPHOS DS/DC CEPH, ORTHOPHOS 5/PLUS/CD
SIRONA DENTAL SYSTEMS GMBH 510(k) NO: K013650(SPECIAL)
ATTN: SHEILA M HEMEON-HEYER PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 06-DEC-01
NORTH ATTLEBORO, MA 02760-4153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM
SIRONA DENTAL SYSTEMS GMBH 510(k) NO: K013659(SPECIAL)
ATTN: SHEILA HEMEON-HEYER PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 06-DEC-01
NORTH ATTLEBORO, MA 02760-4153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERILE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CLAIM LES
SMART GLOVE CORP. SDN BHD 510(k) NO: K013727(TRADITIONAL)
ATTN: NG YEW SOON PHONE NO : 603 329 16100
LOT 6487 BATU 5 3/4 SE DECISION MADE: 07-DEC-01
JALAN KAPAR 510(k) STATEMENT
KLANG SELANGOR, MALAYSIA 42100
DEVICE: 3D HUMERAL HEADS
SMITH & NEPHEW, INC. 510(k) NO: K012378(TRADITIONAL)
ATTN: DAVID HENLEY PHONE NO : 901-399-6487
1450 E. BROOKS ROAD SE DECISION MADE: 13-DEC-01
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPON
SMITH & NEPHEW, INC. 510(k) NO: K013658(SPECIAL)
ATTN: DAVID HENLEY PHONE NO : 901-399-6487
1450 E. BROOKS ROAD SE DECISION MADE: 05-DEC-01
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIRCONIA CERAMIC FEMORAL HEAD - 12/14 TAPER
SMITH & NEPHEW, INC. 510(k) NO: K013989(SPECIAL)
ATTN: JANET JOHNSON GREEN PHONE NO : 901-399-5153
1450 E. BROOKS ROAD SE DECISION MADE: 19-DEC-01
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLO-SPEC
SOL WEISS MD INC 510(k) NO: K013817(TRADITIONAL)
ATTN: SOL WEISS PHONE NO : 818-346-1515
7012 RESEDA BOULEVARD SE DECISION MADE: 21-DEC-01
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
RESEDA, CA 91335
DEVICE: HAND-CARRIED ULTRASOUND SYSTEM
SONOSITE,INC. 510(k) NO: K014116(TRADITIONAL)
ATTN: MICHAEL HOFFMAN PHONE NO : 425-951-1297
21919 30TH DRIVE SE. SE DECISION MADE: 20-DEC-01
BOTHELL, WA 98021-3904 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SOPRO 67D OPERATING ROOM CAMERA
SOPRO 510(k) NO: K013090(TRADITIONAL)
ATTN: PIERRE MONTILLOT PHONE NO : 334 912 70727
PLACE ST. CHRISTOPHE SE DECISION MADE: 13-DEC-01
LES ACCATES-LA VALENTINE 510(k) STATEMENT
MARSEILLE, FRANCE F-13011
DEVICE: TRIMAX
STANDARD TEXTILE CO., INC. 510(k) NO: K012268(TRADITIONAL)
ATTN: BRADLEY J BUSHMAN PHONE NO : 513-761-9255
ONE KNOLLCREST DR. SE DECISION MADE: 03-DEC-01
P.O. BOX 371805 510(k) SUMMARY AVAILABLE FROM FDA
CINCINNATI, OH 45237-1600
DEVICE: STELLARTECH COAGULATION SYSTEM
STELLARTECH RESEARCH CORP. 510(k) NO: K013139(TRADITIONAL)
ATTN: JAMES R SANTOS PHONE NO : 408-331-3000
1346 BORDEAUX DR. SE DECISION MADE: 18-DEC-01
SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISITE RADIOLOGY
STENTOR, INC. 510(k) NO: K013630(TRADITIONAL)
ATTN: GARY J ALLSEBROOK PHONE NO : 510-276-2648
16303 PANORAMIC WAY SE DECISION MADE: 05-DEC-01
SAN LEANDRO, CA 94578 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM
STERIS CORP. 510(k) NO: K013242(ABBREVIATED)
ATTN: ROBERT H MCCALL PHONE NO : 334-213-3150
2720 GUNTER PARK DRIVE EAST SE DECISION MADE: 13-DEC-01
MONTGOMERY, AL 36109 510(k) STATEMENT
DEVICE: SIMPLICITY CLASSIC WING QD INFUSION SET
STERLING MEDIVATIONS, INC. 510(k) NO: K013502(ABBREVIATED)
ATTN: JOEL DOUGLAS PHONE NO : 650-949-0470
25285 LA LOMA DR. SE DECISION MADE: 03-DEC-01
LOS ALTOS HILLS, CA 94022-4583 510(k) STATEMENT
DEVICE: SIMPLICITY INFUSION RESERVOIR FOR USE TO INFUSE MEDICINE, INCLUD
STERLING MEDIVATIONS, INC. 510(k) NO: K013767(TRADITIONAL)
ATTN: JOEL DOUGLAS PHONE NO : 650-814-4083
25285 LA LOMA DR. SE DECISION MADE: 12-DEC-01
LOS ALTOS HILLS, CA 94022-4583 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER PAINPUMP
STRYKER CORP. 510(k) NO: K014091(SPECIAL)
ATTN: NICOLE PETTY PHONE NO : 616-323-7700
4100 E. MILHAM AVENUE SE DECISION MADE: 31-DEC-01
KALAMAZOO, MI 49001 510(k) STATEMENT
DEVICE: MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY
STRYKER LEIBINGER 510(k) NO: K012380(TRADITIONAL)
ATTN: ROBIN L ROWE PHONE NO : 616-323-7700
4100 EAST MILHAM AVE SE DECISION MADE: 03-DEC-01
KALAMAZOO, MI 49001 510(k) STATEMENT
DEVICE: MOST OPTIONS SYSTEM
SULZER ORTHOPEDICS, INC. 510(k) NO: K013031(TRADITIONAL)
ATTN: FRANCES E HARRISON PHONE NO : 512-432-9306
9900 SPECTRUM DR. SE DECISION MADE: 07-DEC-01
AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS
SULZER ORTHOPEDICS, INC. 510(k) NO: K013935(SPECIAL)
ATTN: MITCHELL A DHORITY PHONE NO : 512-432-9202
9900 SPECTRUM DRIVE SE DECISION MADE: 13-DEC-01
AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIGN IM NAIL
SURGICAL IMPLANT GENERATION NETWOR510(k) NO: K013132(TRADITIONAL)
ATTN: DOUG DONNELLY PHONE NO : 509-371-1107
2950 GEORGE WASHINGTON WAY SE DECISION MADE: 20-DEC-01
RICHLAND, WA 99352-1615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRIZM KERATOME BLADE (NIDEK MODEL), MODEL MK8514NI
SURGIN INC 510(k) NO: K013337(TRADITIONAL)
ATTN: DON HAAR PHONE NO : 714-832-6300
14762 BENTLEY CIRCLE SE DECISION MADE: 13-DEC-01
TUSTIN, CA 92780 510(k) STATEMENT
DEVICE: AURIS AEP
SYNAPSYS, INC. 510(k) NO: K012415(TRADITIONAL)
ATTN: JULIEN CHAUSSY PHONE NO : 718-525-3376
150-10 132 AVENUE SE DECISION MADE: 18-DEC-01
JAMAICA, NY 11434 510(k) STATEMENT
DEVICE: NORIAN SRS BONE VOID FILLER
SYNTHES (USA) 510(k) NO: K011897(TRADITIONAL)
ATTN: ANGELA J SILVESTRI PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 20-DEC-01
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES 2.4 MM CANNULATED SCREW
SYNTHES (USA) 510(k) NO: K012945(TRADITIONAL)
ATTN: MATTHEW M HULL PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 03-DEC-01
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES 3.9 MM PELVIC SCREWS
SYNTHES (USA) 510(k) NO: K013044(TRADITIONAL)
ATTN: MATTHEW M HULL PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 03-DEC-01
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES LCP DISTAL TIBIA PLATES
SYNTHES (USA) 510(k) NO: K013248(TRADITIONAL)
ATTN: MATTHEW M HULL PHONE NO : 610-647-9700
P.O. BOX 1766 SE DECISION MADE: 19-DEC-01
1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301-1222
DEVICE: MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) S
SYNTHES (USA) 510(k) NO: K013527(SPECIAL)
ATTN: BONNIE J SMITH PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 21-DEC-01
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TCI-31 LIFELONG OVULATION TESTER
TCI NEW YORK 510(k) NO: K013323(TRADITIONAL)
ATTN: ERIKA B AMMIRATI PHONE NO : 650-949-2768
575 SHIRLYNN COURT SE DECISION MADE: 05-DEC-01
LOS ALTOS, CA 94022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEKMEDIC POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS
TEKMEDIC (M) SDN BHD 510(k) NO: K013317(TRADITIONAL)
ATTN: KOK-KEE HON PHONE NO : 703-941-7656
P.O. BOX 11112 SE DECISION MADE: 17-DEC-01
ALEXANDRIA, VA 22312-9998 510(k) STATEMENT
DEVICE: CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESER
TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K010443(TRADITIONAL)
ATTN: GARRY A COURTNEY PHONE NO : 800-283-7866
125 BLUE BALL ROAD SE DECISION MADE: 11-DEC-01
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TETRAD MODEL TC-EC7-ACP, -L5-, -L7-, -V4-ACP TRANSDUCERS
TETRAD CORP. 510(k) NO: K013849(TRADITIONAL)
ATTN: CHARLES F HOTTINGER PHONE NO : 408-741-1006
357 INVERNESS DR. SOUTH, SE DECISION MADE: 03-DEC-01
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
ENGLEWOOD, CO 80112 THIRD PARTY REVIEW
DEVICE: MODIFICATION TO BLOOD GLUCOSE MONITORING SYSTEM
THERASENSE, INC. 510(k) NO: K012014(TRADITIONAL)
ATTN: EVE A CONNER PHONE NO : 510-749-5400
1360 SOUTH LOOP ROAD SE DECISION MADE: 05-DEC-01
ALAMEDA, CA 94502-7000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIA-PACK CTNI 2ND-GEN ASSAY
TOSOH MEDICS, INC. 510(k) NO: K012820(TRADITIONAL)
ATTN: LOIS NAKAYAMA PHONE NO : 650-615-4970
347 OYSTER POINT BLVD., SE DECISION MADE: 14-DEC-01
SUITE 201 510(k) STATEMENT
SOUTH SAN FRANCISCO, CA 94080
DEVICE: SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPT
TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K013580(TRADITIONAL)
ATTN: CYNTHIA C KNAPP PHONE NO : 800-216-9036
29299 CLEMENS RD., SUITE 1-K SE DECISION MADE: 12-DEC-01
WESTLAKE, OH 44145 510(k) STATEMENT
DEVICE: SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPT
TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K013925(TRADITIONAL)
ATTN: CYNTHIA C KNAPP PHONE NO : 800-216-9036
29299 CLEMENS RD., SUITE 1-K SE DECISION MADE: 21-DEC-01
WESTLAKE, OH 44145 510(k) STATEMENT
DEVICE: HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, VERSION 2
TRIAD MEDICAL, INC. 510(k) NO: K013903(SPECIAL)
ATTN: RITA GIEBEL PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 17-DEC-01
IRVINE, CA 92606 510(k) STATEMENT
DEVICE: WET LIGHT PERSONAL MOISTURIZER
TRIGG LABORATORIES, INC. 510(k) NO: K013086(TRADITIONAL)
ATTN: W. PATRICK NOONAN PHONE NO : 818-887-5600
WARNER CENTER PLAZA SE DECISION MADE: 13-DEC-01
21800 OXNARD STREET, SUITE 840 510(k) STATEMENT
WOODLAND HILLS, CA 91367
DEVICE: DIGIPAN / DPI
TROPHY RADIOLOGIE 510(k) NO: K012514(TRADITIONAL)
ATTN: MARIE-PIERRE LABAT-CAMY PHONE NO : 331 648 08500
4 RUE F. PELLOUTIER CROISSY SE DECISION MADE: 21-DEC-01
BEAUBOURG 510(k) STATEMENT
MARNE LA VALLEE CEDEX 2, FRANCE 77437
DEVICE: MONOJECT PREFILL HEPARIN LOCK FLUSH SYRINGE
TYCO HEALTHCARE 510(k) NO: K013556(TRADITIONAL)
ATTN: DAVID A OLSON PHONE NO : 508-261-8000
15 HAMPSHIRE STREET SE DECISION MADE: 31-DEC-01
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENT LASERVISION
UNION MEDICAL USA 510(k) NO: K012071(TRADITIONAL)
ATTN: ANNIE VELEZ PHONE NO : 305-629-9339
3750 NW 114TH AVENUE SE DECISION MADE: 03-DEC-01
UNIT #5 510(k) STATEMENT
MIAMI, FL 33178
DEVICE: AUTO SUTURE SURGICAL STAPLES
UNITED STATES SURGICAL, A DIVISION510(k) NO: K013860(SPECIAL)
ATTN: CHESTER MCCOY PHONE NO : 203-845-1390
150 GLOVER AVE. SE DECISION MADE: 19-DEC-01
NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGICAL DYNAMICS MENISCAL STAPLE
UNITED STATES SURGICAL, A DIVISION510(k) NO: K013890(SPECIAL)
ATTN: JENNIFER SCHUCK PHONE NO : 203-845-4512
150 GLOVER AVE. SE DECISION MADE: 11-DEC-01
NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NURVO 9000 ENDOCAVITARY COILS
USA INSTRUMENTS, INC. 510(k) NO: K011683(TRADITIONAL)
ATTN: RONY THOMAS PHONE NO : 330-562-1000
1515 DANNER DRIVE SE DECISION MADE: 10-DEC-01
AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRYSTAL 5000 PHASES ARRAY TMJ COIL
USA INSTRUMENTS, INC. 510(k) NO: K013528(TRADITIONAL)
ATTN: RONY THOMAS PHONE NO : 330-562-1000
1515 DANNER DRIVE SE DECISION MADE: 13-DEC-01
AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHOULDER COIL
USA INSTRUMENTS, INC. 510(k) NO: K013541(TRADITIONAL)
ATTN: RONY THOMAS PHONE NO : 330-562-1000
1515 DANNER DRIVE SE DECISION MADE: 14-DEC-01
AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VANGUARD REPROCESSED FEMORAL COMPRESSION DEVICE
VANGUARD MEDICAL CONCEPTS, INC. 510(k) NO: K011832(TRADITIONAL)
ATTN: MIKE SAMMON PHONE NO : 863-683-8680
5307 GREAT OAK DR. SE DECISION MADE: 21-DEC-01
LAKELAND, FL 33815 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GELBISH VASCULAR DILATOR
VASCUMETRIX, LLC 510(k) NO: K012256(TRADITIONAL)
ATTN: MIKE HAMMONS PHONE NO : 480-807-6300
2824 N. POWER RD. SE DECISION MADE: 20-DEC-01
SUITE 113-278 510(k) SUMMARY AVAILABLE FROM FDA
MEAS, AZ 85215-1674
DEVICE: VENTLAB HYPERINFLATION BAG SYSTEM
VENTLAB CORP. 510(k) NO: K013308(TRADITIONAL)
ATTN: MARGE WALLS-WALKER PHONE NO : 336-492-2636
2934 HWY. 601 NORTH SE DECISION MADE: 20-DEC-01
MOCKSVILLE, NC 27028 510(k) STATEMENT
DEVICE: VERTIS PNT CONTROL UNIT, VERTIS PNT SAFEGUIDE KIDS, MODELS CU100
VERTIS NEUROSCIENCE, INC. 510(k) NO: K011702(TRADITIONAL)
ATTN: LORI GLASTETTER PHONE NO : 206-902-1902
2101 FOURTH AVE STE 200 SE DECISION MADE: 21-DEC-01
SEATTLE, WA 98121-2329 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIATRONIC V3D CALCIUM SCORING
VIATRONIX, INC. 510(k) NO: K013146(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001
55 NORTHERN BLVD. SE DECISION MADE: 07-DEC-01
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: VICTORCH MEDITEK'S HCG TEST CARD
VICTORCH MEDITEK, INC. 510(k) NO: K013678(TRADITIONAL)
ATTN: PIERCE LIU PHONE NO : 858-530-9191
7313 CARROLL RD., SUITE A-B SE DECISION MADE: 27-DEC-01
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: VICTORCH HCG TEST STRIP
VICTORCH MEDITEK, INC. 510(k) NO: K013702(TRADITIONAL)
ATTN: PIERCE LIU PHONE NO : 858-530-9191
7313 CARROLL RD., SUITE A-B SE DECISION MADE: 27-DEC-01
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: RF GENERATORS, DISPOSABLE CARTRIDGE KIT, DISPOSABLE CARTRIDGE, R
VIDAMED, INC. 510(k) NO: K012587(TRADITIONAL)
ATTN: YI CHEN PHONE NO : 510-492-4934
46107 LANDING PKWY. SE DECISION MADE: 11-DEC-01
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GORE INTRODUCER SHEATH
W. L. GORE & ASSOCIATES, INC. 510(k) NO: K013282(TRADITIONAL)
ATTN: R. LARRY PRATT PHONE NO : 928-779-2771
3450 WEST KLINE LANE SE DECISION MADE: 14-DEC-01
P.O. BOX 500 510(k) SUMMARY AVAILABLE FROM FDA
FLAGSTAFF, AZ 86002-0500
DEVICE: GORE DRAPEABLE ST/LT REGENERATIVE MEMBRANE
W.L. GORE & ASSOCIATES,INC 510(k) NO: K013346(TRADITIONAL)
ATTN: JACQUELINE KALBACH PHONE NO : 928-864-3731
3450 KILTIE LANE SE DECISION MADE: 19-DEC-01
P.O. BOX 500 510(k) SUMMARY AVAILABLE FROM FDA
FLAGSTAFF, AZ 86002-0500
DEVICE: AUROPAL, ORDER-NO.: 2101
WIELAND EDELMETALLE GMBH & CO. 510(k) NO: K012839(TRADITIONAL)
ATTN: GERHARD P0LZER PHONE NO : 49 723 13705219
SCHWENNINGER STRABE 13 SE DECISION MADE: 31-DEC-01
D-75179 PFORZHEIM, GERMANY 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WIENER LAB. GLICEMIA ENZIMATICA AA MODELS 1 X 250 ML CAT. #14001
WIENER LABORATORIES S.A.I.C. 510(k) NO: K011953(TRADITIONAL)
ATTN: VIVIANA CETOLA PHONE NO : 543 414 329191
2944 RIOBAMBA SE DECISION MADE: 21-DEC-01
ROSARIO, ARGENTINA 2000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002
WIENER LABORATORIES S.A.I.C. 510(k) NO: K013652(TRADITIONAL)
ATTN: VIVIANA CETOLA PHONE NO : 543 414 329191
2944 RIOBAMBA SE DECISION MADE: 21-DEC-01
ROSARIO, ARGENTINA 2000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GUARDIAN LIMB SALVAGE SYSTEM
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K013035(TRADITIONAL)
ATTN: EHAB M ESMAIL PHONE NO : 901-867-4457
5677 AIRLINE RD. SE DECISION MADE: 07-DEC-01
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE BLUE LATEX EXAMINATION GLOVE, NON-STERILE (PROTEIN C
WRP SPECIALTY PRODUCTS SDN. BHD. 510(k) NO: K013942(TRADITIONAL)
ATTN: MOHD H HUSSEIN PHONE NO : 603 870 69788
LOT11 JALAN2 PERUSAHAAN BANDAR SE DECISION MADE: 31-DEC-01
KAWASAN BARU SALAK TINGGI 510(k) SUMMARY AVAILABLE FROM FDA
SEPANG, SELANGOR, MALAYSIA 43900
DEVICE: ZEUS SCIENTIFIC, INC. ATHENA MULTI-LYTE ANA TEST SYSTEM
ZEUS SCIENTIFIC, INC. 510(k) NO: K011244(TRADITIONAL)
ATTN: MARK J KOPNITSKY PHONE NO : 908-526-3744
P.O. BOX 38 SE DECISION MADE: 10-DEC-01
RARITAN, NJ 08869 510(k) STATEMENT
DEVICE: PROLONG HIGHLY CROSSLINKED POLYETHTYLENE CRUCIATE RETAINING (CR)
ZIMMER, INC. 510(k) NO: K013991(SPECIAL)
ATTN: STEPHEN H MCKELVEY PHONE NO : 219-372-4944
P.O. BOX 708 SE DECISION MADE: 27-DEC-01
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 286
TOTAL WITH SUMMARIES 232
TOTAL WITH STATEMENTS 54
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