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510(k)s Final Decisions Rendered for February 2003 |
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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-FEB-2003 THROUGH 28-FEB-2003
DEVICE: W & H LISA STEAM STERILIZER
A-DEC, INC. 510(k) NO: K022816(ABBREVIATED)
ATTN: TOM LOUISELL PHONE NO : 503-538-9471
2601 CRESTVIEW DRIVE SE DECISION MADE: 07-FEB-03
NEWBERG, OR 97132-9257 510(k) STATEMENT
DEVICE: BOVIE IDS-300 HIGH FREQUENCY ELECTROSURGICAL GENERATOR
AARON MEDICAL INDUSTRIES 510(k) NO: K022856(TRADITIONAL)
ATTN: RICHARD A KOZLOFF PHONE NO : 727-384-2323
7100 30TH AVE. NORTH SE DECISION MADE: 10-FEB-03
ST. PETERSBURG, FL 33710-2902 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRIMELUNG
ACCUIMAGE DIAGNOSTICS CORP. 510(k) NO: K024149(TRADITIONAL)
ATTN: OSCAR G CARBO PHONE NO : 650-875-0192
400 GRANDVIEW DRIVE SE DECISION MADE: 21-FEB-03
SOUTH SAN FRANSISCO, CA 94080 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACON STREP A TWIST TEST DEVICE
ACON LABORATORIES CO. 510(k) NO: K023766(TRADITIONAL)
ATTN: EDWARD TUNG PHONE NO : 858-535-2030
4108 SORRENTO VALLEY BLVD. SE DECISION MADE: 10-FEB-03
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD, ACON ONE S
ACON LABORATORIES, INC. 510(k) NO: K023946(TRADITIONAL)
ATTN: EDWARD TUNG PHONE NO : 858-535-2030
4108 SORRENTO VALLEY BLVD. SE DECISION MADE: 05-FEB-03
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGNETIC RESONANCE DIAGNOSTIC DEVICE
ADVANCED IMAGING RESEARCH, INC. 510(k) NO: K023929(TRADITIONAL)
ATTN: RAVI SRINIVASAN PHONE NO : 216-426-1461
4700 LAKESIDE AVENUE SE DECISION MADE: 21-FEB-03
SUITE 400 510(k) SUMMARY AVAILABLE FROM FDA
CLEVELAND, OH 44114-3834
DEVICE: MAGIC INFUSION CATHETER
ADVANCED INTERVENTIONAL TECHNOLOGI510(k) NO: K023351(TRADITIONAL)
ATTN: TRACY PALMER BERNS PHONE NO : 978-371-0066
100 MAIN STREET SE DECISION MADE: 20-FEB-03
SUITE 120 510(k) SUMMARY AVAILABLE FROM FDA
CONCORD, MA 01742
DEVICE: COMPLETE BRAND MULTI-PURPOSE SOLUTION
ADVANCED MEDICAL OPTICS, INC. 510(k) NO: K024166(ABBREVIATED)
ATTN: PAUL J NOWACKI PHONE NO : 714-247-8601
1700 E. ST. ANDREW PLACE SE DECISION MADE: 12-FEB-03
P.O. BOX 25162 510(k) SUMMARY AVAILABLE FROM FDA
SANTA ANA, CA 92799-5162
DEVICE: THE VEST AIRWAY CLEARANCE SYSTEM, MODEL 104
ADVANCED RESPIRATORY 510(k) NO: K024309(TRADITIONAL)
ATTN: ERIC J LARSON PHONE NO : 651-234-1211
1020 WEST COUNTY ROAD F SE DECISION MADE: 21-FEB-03
ST. PAUL, MN 55126 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: 0.55% ORTH-PHTHALALDEHYDE SOLUTION
ADVANCED STERILIZATION PRODUCTS 510(k) NO: K030004(TRADITIONAL)
ATTN: NEELU MEDHEKAR PHONE NO : 949-789-3838
33 TECHNOLOGY DRIVE SE DECISION MADE: 27-FEB-03
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VENAFLOW REUSABLE CALF AIRCELL, MODEL 3018, VENAFLOW DISPOSABLE
AIRCAST, INC. 510(k) NO: K023800(TRADITIONAL)
ATTN: STEPHEN L KENNEY PHONE NO : 908-273-6349
92 RIVER RD. SE DECISION MADE: 10-FEB-03
SUMMIT, NJ 07902 510(k) STATEMENT
DEVICE: TRILAMINATE DRAPES/TIBURON
ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K023419(TRADITIONAL)
ATTN: SHARON NICHOLS PHONE NO : 847-785-3311
1500 WAUKEGAN RD. BLDG. WM SE DECISION MADE: 11-FEB-03
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED EXTERNAL FIXATION DEVICE
ALLIANCE MEDICAL CORP. 510(k) NO: K023714(TRADITIONAL)
ATTN: DON SELVEY PHONE NO : 480-763-5300
10232 SOUTH 51ST ST. SE DECISION MADE: 03-FEB-03
PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED COMPRESSION SLEEVE
ALLIANCE MEDICAL, INC. 510(k) NO: K021654(TRADITIONAL)
ATTN: LORRI CHAVEZ PHONE NO : 480-763-5300
10232 SOUTH 51 STREET SE DECISION MADE: 05-FEB-03
PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOARC SP SLING KIT
AMERICAN MEDICAL SYSTEMS, INC. 510(k) NO: K030123(SPECIAL)
ATTN: MARK MCINTYRE PHONE NO : 952-930-6120
10700 BREN RD., WEST SE DECISION MADE: 06-FEB-03
MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURESTEP PROPOXYPHENE (PPX) DRUG SCREEN TEST, INSTACHECK PROPOXY
APPLIED BIOTECH, INC. 510(k) NO: K024332(TRADITIONAL)
ATTN: DOUG HARDING PHONE NO : 858-587-6771
10237 FLANDERS CT. SE DECISION MADE: 28-FEB-03
SAN DIEGO, CA 92121 510(k) STATEMENT
DEVICE: APPLIED BIOTECH INSTACUP MULTI-DRUG TEST CUP FOR DRUGS OG ABUSE
APPLIED BIOTECH, INC. 510(k) NO: K030084(SPECIAL)
ATTN: DOUG HARDING PHONE NO : 858-587-6771
10237 FLANDERS CT. SE DECISION MADE: 06-FEB-03
SAN DIEGO, CA 92121 510(k) STATEMENT
DEVICE: PREPARE CARTRIDGE
APPRO HEALTHCARE, INC. 510(k) NO: K023890(TRADITIONAL)
ATTN: JOHN R SEMLER PHONE NO : 716-855-1068
847 MAIN STREET SE DECISION MADE: 07-FEB-03
BUFFALO, NY 14203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALIBI BIOLOGICAL INDICATOR, MODEL WS
ARDEN LABORATORIES, INCORPORATED 510(k) NO: K024079(ABBREVIATED)
ATTN: ANGELEA STRANTZ PHONE NO : 651-762-9225
468B STILLWATER ROAD SE DECISION MADE: 27-FEB-03
WILLERNIE, MN 55090-0687 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES, PURPLE COLOR
ARISTA LATINDO INDUSTRIAL, LTD. P.510(k) NO: K023072(TRADITIONAL)
ATTN: LINGA SUMARTA PHONE NO : 62 21 66620201
128 JALAN KYAI HAJI MUHAMMAD SE DECISION MADE: 13-FEB-03
MANSYUR 510(k) STATEMENT
JAKARTA BARAT, INDONESIA 11210
DEVICE: FIRST RESPONSE PREGNANCY TEST
ARMKEL, LLC. 510(k) NO: K030258(TRADITIONAL)
ATTN: STEPHEN C KOLAKOWSKY PHONE NO : 609-279-7748
469 NORTH HARRISON ST SE DECISION MADE: 25-FEB-03
PRINCETON, NJ 08543 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHROCARE ENT COBLATOR SURGERY SYSTEM
ARTHROCARE CORP. 510(k) NO: K030108(SPECIAL)
ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-736-0224
680 VAQUEROS AVE. SE DECISION MADE: 03-FEB-03
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIASCOPE II
ASTRON CLINICA LIMITED 510(k) NO: K023729(TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 410-451-0639
PO BOX 4341 SE DECISION MADE: 03-FEB-03
CROFTON, MD 21114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NYLON SUTURE
AUROLAB 510(k) NO: K024090(TRADITIONAL)
ATTN: MICHAEL G PRICE PHONE NO : 608-270-3880
6441 ENTERPRISE LANE SE DECISION MADE: 28-FEB-03
SUITE 214 510(k) SUMMARY AVAILABLE FROM FDA
MADISON, WI 53719
DEVICE: SILK SUTURES
AUROLAB 510(k) NO: K024091(TRADITIONAL)
ATTN: MICHAEL G PRICE PHONE NO : 608-270-3880
6441 ENTERPRISE LANE SE DECISION MADE: 28-FEB-03
SUITE 214 510(k) SUMMARY AVAILABLE FROM FDA
MADISON, WI 53719
DEVICE: MEDTRONIC MINIMED SOF-SITE INFUSION SET, MODELS MMT-358S6, MMT-3
AVAIL MEDICAL PRODUCTS, INC. 510(k) NO: K030137(TRADITIONAL)
ATTN: COURTLAND IMEL PHONE NO : 972-929-4800
8300 ESTERS ROAD SE DECISION MADE: 19-FEB-03
SUITE 930 510(k) SUMMARY AVAILABLE FROM FDA
IRVING, TX 75063
DEVICE: SYNTRA + DIALYZER, MODEL 200
BAXTER HEALTHCARE CORP. 510(k) NO: K023664(TRADITIONAL)
ATTN: DAVID E CURTIN PHONE NO : 847-473-6079
1620 WAUKEGAN RD, MPGR-A2E SE DECISION MADE: 21-FEB-03
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST
BAYER CORP. 510(k) NO: K023944(ABBREVIATED)
ATTN: THOMAS F FLYNN PHONE NO : 508-359-3825
63 NORTH ST. SE DECISION MADE: 11-FEB-03
MEDFIELD, MA 02052-1688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD INTEGRA SYRINGE
BD 510(k) NO: K023752(TRADITIONAL)
ATTN: PASQUALE AMATO PHONE NO : 201-847-4513
ONE BECTON DRIVE MC226 SE DECISION MADE: 07-FEB-03
FRANKLIN LAKES, NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN 0.25 - 16
BD DIAGNOSTIC SYSTEMS 510(k) NO: K030091(TRADITIONAL)
ATTN: KATHRYN BABKA POWERS PHONE NO : 410-316-4260
7 LOVETON CIRCLE SE DECISION MADE: 28-FEB-03
SPARKS, MD 21152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE C
BECKMAN COULTER, INC. 510(k) NO: K024210(TRADITIONAL)
ATTN: ANNETTE HELLIE PHONE NO : 714-993-8767
200 SOUTH KRAEMER BLVD. SE DECISION MADE: 24-FEB-03
BREA, CA 92822 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TETRACYCLINE - 0.5-16
BECTON, DICKINSON AND COMPANY 510(k) NO: K024153(TRADITIONAL)
ATTN: MICHELLE B BANDY PHONE NO : 410-316-4778
7 LOVETON CIR. SE DECISION MADE: 10-FEB-03
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEM-OSTETIC BONE; CEMO-10G, CEMO-20G, CEMO-30G, CEMO-40G, CEMO-6
BERKELEY ADVANCED BIOMATERIALS, IN510(k) NO: K030266(SPECIAL)
ATTN: FRANCOIS GENIN PHONE NO : 510-883-1644
1933 DAVIS ST. SUITE 307 SE DECISION MADE: 20-FEB-03
SAN LEANDRO, CA 94577 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUICHEK D-DIMER CONTROL, MODEL 356, 357
BIO-RAD 510(k) NO: K030182(TRADITIONAL)
ATTN: ELIZABETH PLATT PHONE NO : 949-598-1280
9500 JERONIMO RD. SE DECISION MADE: 24-FEB-03
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO THE MAESTRO SYSTEM
BIOHORIZONS IMPLANT SYSTEMS, INC. 510(k) NO: K030463(SPECIAL)
ATTN: WINSTON GREER PHONE NO : 205-986-1205
ONE PERIMETER PARK SOUTH SE DECISION MADE: 26-FEB-03
SUITE 230, SOUTH 510(k) SUMMARY AVAILABLE FROM FDA
BIRMINGHAM, AL 35243
DEVICE: WATERLASE FOR APICOECTOMY
BIOLASE TECHNOLOGY, INC. 510(k) NO: K022803(TRADITIONAL)
ATTN: IOANA M RIZOIU PHONE NO : 949-361-1200
981 CALLE AMANECER SE DECISION MADE: 03-FEB-03
SAN CLEMENTE, CA 92673 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-2
BIOMEDICAL LIFE SYSTEMS 510(k) NO: K021270(TRADITIONAL)
ATTN: HANS REISS PHONE NO : 760-727-5600
P.O. BOX 1360 SE DECISION MADE: 06-FEB-03
VISTA, CA 92085 510(k) STATEMENT
DEVICE: ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-3
BIOMEDICAL LIFE SYSTEMS 510(k) NO: K021271(TRADITIONAL)
ATTN: HANS REISS PHONE NO : 760-727-5600
P.O. BOX 1360 SE DECISION MADE: 06-FEB-03
VISTA, CA 92085 510(k) STATEMENT
DEVICE: ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS02-5
BIOMEDICAL LIFE SYSTEMS, INC. 510(k) NO: K021588(TRADITIONAL)
ATTN: RICHARD SAXON PHONE NO : 760-727-5600
P.O. BOX 1360 SE DECISION MADE: 13-FEB-03
VISTA, CA 92085-1360 510(k) STATEMENT
DEVICE: HA PMI FEMORAL HIP STEM
BIOMET ORTHOPEDICS, INC. 510(k) NO: K030048(SPECIAL)
ATTN: PATRICIA BERES PHONE NO : 574-267-6639
56 EAST BELL DRIVE SE DECISION MADE: 05-FEB-03
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: CALCIGEN PSI BONE GRAFT SUBSTITUTE
BIOMET, INC. 510(k) NO: K030178(TRADITIONAL)
ATTN: MARY VERSTYNEN PHONE NO : 574-267-6639
56 EAST BELL DR. SE DECISION MADE: 26-FEB-03
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL
BIOSITE INCORPORATED 510(k) NO: K030286(SPECIAL)
ATTN: JEFFREY R DAHLEN PHONE NO : 858-455-4808
11030 ROSELLE ST. SE DECISION MADE: 21-FEB-03
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TECHNOS MP, MODEL AU6
BIOSOUND ESAOTE, INC. 510(k) NO: K023255(TRADITIONAL)
ATTN: COLLEEN HITTLE DENSMORE PHONE NO : 317-849-1793
8000 CASTLEWAY DR. SE DECISION MADE: 11-FEB-03
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TESCERA GLAZING RESIN, MODEL T-1804, BISCOVER XT, MODEL G-93220P
BISCO, INC. 510(k) NO: K024046(TRADITIONAL)
ATTN: STEPHEN SMITH PHONE NO : 847-534-6146
1100 WEST IRVING PARK RD. SE DECISION MADE: 06-FEB-03
SCHAUMBURG, IL 60193 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BISCOVER LIQUID POLISH KIT, BISCOVER LIQUID POLISH AND BISCOVER
BISCO, INC. 510(k) NO: K030354(SPECIAL)
ATTN: STEPHEN D SMITH PHONE NO : 847-534-6136
1100 WEST IRVING PARK RD. SE DECISION MADE: 19-FEB-03
SCHAUMBURG, IL 60193 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM
BLACKSTONE MEDICAL, INC. 510(k) NO: K030241(SPECIAL)
ATTN: DEAN CIPORKIN PHONE NO : 413-731-8711
90 BROOKSDALE DR. SE DECISION MADE: 21-FEB-03
SPRINGFIELD, MA 01104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRECISION CAPILLARIES FOR MICROMANIPULATION
BRINKMANN INSTRUMENTS, INC. 510(k) NO: K024302(TRADITIONAL)
ATTN: CYNTHIA J.M. NOLTE PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 19-FEB-03
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMALL BARD VENTRALEX PATCH
C.R. BARD, INC. 510(k) NO: K024008(TRADITIONAL)
ATTN: BRIAN A KANERVIKO PHONE NO : 401-463-7000
100 SOCKANOSSETT CROSSROAD SE DECISION MADE: 20-FEB-03
P.O. BOX 8500 510(k) SUMMARY AVAILABLE FROM FDA
CRANSTON, RI 02920
DEVICE: SILICONE DUAL LUMEN RADPICC CATHETERS
C.R. BARD, INC. 510(k) NO: K030255(SPECIAL)
ATTN: PEGGY KEIFFER PHONE NO : 801-595-0700
5425 WEST AMELIA EARHART DR. SE DECISION MADE: 07-FEB-03
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100
CARDIOVENTION, INC. 510(k) NO: K030141(SPECIAL)
ATTN: TESSA YAMUT PHONE NO : 408-844-5130
3045 STENDER WAY SE DECISION MADE: 26-FEB-03
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPINEMED
CERT HEALTH SCIENCES, LLC 510(k) NO: K030060(TRADITIONAL)
ATTN: LYNETTE HOWARD PHONE NO : 908-788-4580
203 MAIN STREET SE DECISION MADE: 05-FEB-03
PMB 166 510(k) SUMMARY AVAILABLE FROM FDA
FLEMINGTON, NJ 08822 THIRD PARTY REVIEW
DEVICE: AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
CIBA VISION CORP. 510(k) NO: K023455(TRADITIONAL)
ATTN: STEVEN DOWDLEY PHONE NO : 687-415-3897
11460 JOHNS CREEK PKWY. SE DECISION MADE: 28-FEB-03
DULUTH, GA 30097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COAXIA FLOCONTROL CATHETER
COAXIA INC 510(k) NO: K023914(TRADITIONAL)
ATTN: GREGORY W SACHS PHONE NO : 763-315-8383
10900 73RD AVE. N. SE DECISION MADE: 21-FEB-03
MAPLE GROVE, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONTREET FOAM ADHESIVE/NON-ADHESIVE
COLOPLAST CORP. 510(k) NO: K022416(TRADITIONAL)
ATTN: ELIZABETH BOOTS PHONE NO : 507-386-4362
1940 COMMERCE DR. SE DECISION MADE: 03-FEB-03
NORTH MANKATO, MN 56003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER
COMPUTER MOTION, INC. 510(k) NO: K030240(SPECIAL)
ATTN: CATHY STUPAK PHONE NO : 805-685-3729
130 CREMONA DRIVE, SUITE B SE DECISION MADE: 21-FEB-03
GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENHANCE-S PLUS H
CONCEPTION TECHNOLOGY, INC. 510(k) NO: K030116(SPECIAL)
ATTN: GRACE HOLLAND PHONE NO : 929-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 12-FEB-03
IRVINE, CA 92606 510(k) STATEMENT
DEVICE: CONTAFLEX 38 (POLYMACON) SPHERICAL SOFT CONTACT LENS FOR DAILY W
CONTAMAC LTD. 510(k) NO: K023987(TRADITIONAL)
ATTN: MARTIN DALSING PHONE NO : 970-243-5490
623 GLACIER DRIVE SE DECISION MADE: 26-FEB-03
GRAND JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONTAFLEX 55 (METHAFILCON) SPHERICAL SOFT CONTACT LENS FOR DAILY
CONTAMAC LTD. 510(k) NO: K023989(TRADITIONAL)
ATTN: MARTIN DALSING PHONE NO : 970-243-5490
623 GLACIER DRIVE SE DECISION MADE: 26-FEB-03
GRAND JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONTAFLEX GM3 49% (ACOFILCON B) SPHERICAL SOFT CONTACT LENS FOR
CONTAMAC LTD. 510(k) NO: K024045(TRADITIONAL)
ATTN: MARTIN DALSING PHONE NO : 970-243-5490
623 GLACIER DRIVE SE DECISION MADE: 14-FEB-03
GRAND JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 6203
CONTEMPORARY PRODUCTS, INC. 510(k) NO: K022865(TRADITIONAL)
ATTN: BARRY A SCHWARTZ PHONE NO : 207-797-4647
470 RIVERSIDE ST SE DECISION MADE: 13-FEB-03
PORTLAND, ME 04103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDLITE Q-SWITHCED LASER
CONTINUUM ELECTRO-OPTICS, INC. 510(k) NO: K022709(TRADITIONAL)
ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640
200 GREGORY LANE SE DECISION MADE: 20-FEB-03
SUITE C-100 510(k) SUMMARY AVAILABLE FROM FDA
PLEASANT HILL, CA 94523
DEVICE: COOK NEPHROSTOMY DILATION BALLOON CATHETER SET
COOK UROLOGICAL, INC. 510(k) NO: K024050(TRADITIONAL)
ATTN: DEBBIE SCHMITT PHONE NO : 812-829-4891
1100 WEST MORGAN ST. SE DECISION MADE: 27-FEB-03
SPENCER, IN 47460 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CVSI PERIPHERAL BALLOON CATHETER; CVSI CATHETER INFLATION UNIT
CRYOVASCULAR SYSTEMS, INC. 510(k) NO: K023463(TRADITIONAL)
ATTN: R. MICHAEL CROMPTON PHONE NO : 650-678-7593
160 KNOWLES DRIVE SE DECISION MADE: 19-FEB-03
LOS GATOS, CA 95032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ICLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0002
CURELIGHT LTD 510(k) NO: K030338(SPECIAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, N.W. SE DECISION MADE: 12-FEB-03
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDSTAR SYSTEM, MODELS 533-300
CYBERNET MEDICAL 510(k) NO: K020534(TRADITIONAL)
ATTN: DAVID A.C. GREEN PHONE NO : 760-599-9661
727 AIRPORT BLVD. SE DECISION MADE: 11-FEB-03
ANN ARBOR, MI 48108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE BREATHE EZ ANTI-SNORING DEVICE
D&S REDHAGE 510(k) NO: K022891(TRADITIONAL)
ATTN: DANIEL J REDHAGE PHONE NO : 573-237-3714
5901 VEDDER ROAD SE DECISION MADE: 19-FEB-03
NEW HAVEN, MO 63068 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A16 BLOOD FLOW MEASUREMENT SYSTEM
D. E. HOKANSON, INC. 510(k) NO: K023707(SPECIAL)
ATTN: D. EUGENE HOKANSON PHONE NO : 425-882-1689
12840 N.E. 21ST PL. SE DECISION MADE: 12-FEB-03
BELLEVUE, WA 98005-1910 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: N LATEX IGA
DADE BEHRING, INC. 510(k) NO: K024038(TRADITIONAL)
ATTN: KATHLEEN A DRAY-LYONS PHONE NO : 781-826-4551
P.O. BOX 6101 SE DECISION MADE: 13-FEB-03
NEWARK, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DAN KERRISON RONGEURS, MODELS K1 + BILLY 1
DANNORITZER MEDICAL INSTRUMENTS 510(k) NO: K023868(TRADITIONAL)
ATTN: DAGMAR S MASER PHONE NO : 828-622-7572
271 WALDROUP ROAD SE DECISION MADE: 07-FEB-03
P.O. BOX 457 510(k) STATEMENT
HOT SPRINGS, NC 28783
DEVICE: DAVOL ARTHROVENT OUTFLOW TUBING
DAVOL, INC. 510(k) NO: K030307(TRADITIONAL)
ATTN: LUCINDA L FOX PHONE NO : 401-463-7000
SUBSIDIARY OF C.R. BARD SE DECISION MADE: 13-FEB-03
100 SOCKANOSSETT CROSSROAD 510(k) SUMMARY AVAILABLE FROM FDA
CRANSTON, RI 02920 THIRD PARTY REVIEW
DEVICE: DIAMONDCOAT ULTRASONIC INSERTS
DENTSPLY INTERNATIONAL 510(k) NO: K030111(SPECIAL)
ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511
570 WEST COLLEGE AVENUE SE DECISION MADE: 07-FEB-03
YORK, PA 17404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUMMIT OCT SPINAL SYSTEM MINIPOLYAXIAL SCREWS
DEPUY ACROMED 510(k) NO: K030103(SPECIAL)
ATTN: FRANK MASS PHONE NO : 508-828-3390
325 PARAMOUNT DR. SE DECISION MADE: 05-FEB-03
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGICAL TITANIUM MESH SYSTEM
DEPUY ACROMED 510(k) NO: K030249(SPECIAL)
ATTN: KAREN F JURCZAK PHONE NO : 508-828-3704
325 PARAMOUNT DR. SE DECISION MADE: 14-FEB-03
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO MOSS MIAMI SPINAL SYSTEM POLYAXIAL SCREWS
DEPUY ACROMED 510(k) NO: K030383(SPECIAL)
ATTN: LISA GILMAN PHONE NO : 508-880-8287
325 PARAMOUNT DR. SE DECISION MADE: 26-FEB-03
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTSET HV BONE CEMENT
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K023012(TRADITIONAL)
ATTN: JANET JOHNSON PHONE NO : 574-371-4907
700 ORTHOPAEDIC DR. SE DECISION MADE: 13-FEB-03
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: DEPUY SUMMIT BASIC PRESS-FIT HIP STEM
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K030122(SPECIAL)
ATTN: CHERYL HASTINGS PHONE NO : 574-372-7006
700 ORTHOPAEDIC DR. SE DECISION MADE: 05-FEB-03
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: CARDIUS-1 AND CARDIS-2
DIGIRAD CORP. 510(k) NO: K030085(SPECIAL)
ATTN: COREY STEWART PHONE NO : 858-578-5300
9350 TRADE PLACE SE DECISION MADE: 05-FEB-03
SAN DIEGO, CA 92126-6334 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRAVELAIR PORTABLE COMPRESSION SYSTEM
DYNAMIC AIR, INC. 510(k) NO: K022340(TRADITIONAL)
ATTN: BRENT KNIGHT PHONE NO : 800-572-0836
3495 BANKHEAD HIGHWAY SE DECISION MADE: 19-FEB-03
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
ATLANTA, GA 30331
DEVICE: ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR
ELAN DIAGNOSTICS 510(k) NO: K023407(TRADITIONAL)
ATTN: WYNN STOCKING PHONE NO : 714-672-3553
1075 W. LAMBERT RD., SUITE D SE DECISION MADE: 14-FEB-03
BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMBOL-X AORTIC FILTERS,ETRA-SMALL,SMALL,MEDIUM,LARGE,EXTRA LARGE
EMBOL-X, INC. 510(k) NO: K022071(TRADITIONAL)
ATTN: ED LEE PHONE NO : 650-390-0280
645 CLYDE AVE. SE DECISION MADE: 14-FEB-03
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDO-GLIDE GUIDEWIRE
ENDO-THERAPEUTICS, INC. 510(k) NO: K023603(TRADITIONAL)
ATTN: TODD ADKISSON PHONE NO : 727-726-2446
1183 CEDAR ST. SE DECISION MADE: 19-FEB-03
SAFETY HARBOR, FL 34695-2908 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SLEEPSCREEN/APNOESCREEN CARDIO
ERICH JAEGER GMBH 510(k) NO: K021138(TRADITIONAL)
ATTN: BRIAN LONG PHONE NO : 714-283-2228
22705 SAVI RANCH PARKWAY SE DECISION MADE: 12-FEB-03
YORBA LINDA, CA 92887-4645 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORIA SPINAL CLIP SYSTEM, TYPES BD AND BJ
EUROSURGICAL S.A. 510(k) NO: K023994(SPECIAL)
ATTN: KAREN E WARDEN PHONE NO : 304-598-0525
7000 HAMPTON CENTER SE DECISION MADE: 05-FEB-03
SUITE G1 510(k) SUMMARY AVAILABLE FROM FDA
MORGANTOWN, WV 26505
DEVICE: ORIA SPINAL CLIP SYSTEM EXTENDED OMNIAXIAL CONNECTORS (CO05 & CO
EUROSURGICAL S.A. 510(k) NO: K030252(SPECIAL)
ATTN: KAREN E WARDEN PHONE NO : 304-598-0525
7000 HAMPTON CENTER SE DECISION MADE: 21-FEB-03
SUITE G1 510(k) SUMMARY AVAILABLE FROM FDA
MORGANTOWN, WV 26505
DEVICE: ORIA SPINAL CLIP SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL0
EUROSURGICAL S.A. 510(k) NO: K030253(SPECIAL)
ATTN: KAREN E WARDEN PHONE NO : 304-598-0525
7000 HAMPTON CENTER SE DECISION MADE: 21-FEB-03
SUITE G1 510(k) SUMMARY AVAILABLE FROM FDA
MORGANTOWN, WV 26505
DEVICE: ACUMATCH P-SERIES POROUS PRESS-FIT FEMORAL COMPONENT
EXACTECH, INC. 510(k) NO: K030236(SPECIAL)
ATTN: GARY MILLER PHONE NO : 352-377-1140
2320 N.W. 66TH CT. SE DECISION MADE: 20-FEB-03
GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES
FCI OPHTHALMICS, INC. 510(k) NO: K030054(TRADITIONAL)
ATTN: HILLARD WELCH PHONE NO : 508-775-5567
344 ANNABELLE POINT ROAD SE DECISION MADE: 26-FEB-03
CENTERVILLE, MA 02632-2402 510(k) STATEMENT
DEVICE: FORTUNE SILICONE VACUUM SUCTION, MODEL #1300
FORTUNE MEDICAL INSTRUMENT CORP. 510(k) NO: K021193(TRADITIONAL)
ATTN: TAIPEI HSIEN PHONE NO : 886 226 360845
12-9, LIN 5, MAO-CHANG VILLAGE SE DECISION MADE: 12-FEB-03
SAN-CHIH HSIANG 510(k) STATEMENT
TAIPEI HSIEN, CHINA (TAIWAN)
DEVICE: FRIOS ALGIPORE
FRIADENT GMBH 510(k) NO: K023799(TRADITIONAL)
ATTN: CAROL PATTERSON PHONE NO : 949-462-0900
21911 ERIE LANE SE DECISION MADE: 05-FEB-03
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE DISCOVERY LS SYSTEM
GE MEDICAL SYSTEMS 510(k) NO: K023988(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894
P.O. 414 SE DECISION MADE: 04-FEB-03
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO DASH 3000/4000 PATIENT MONITOR
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K030431(SPECIAL)
ATTN: KAREN M LUNDE PHONE NO : 414-362-3329
8200 WEST TOWER AVE. SE DECISION MADE: 26-FEB-03
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GELFLEX DELTA SOFT CONTACT LENS MATERIAL METHAFILCON A 55% WATER
GELFLEX 510(k) NO: K024003(TRADITIONAL)
ATTN: PETER G BRYANT PHONE NO : 618 944 34944
THREE HUTTON STREET SE DECISION MADE: 05-FEB-03
OSBORNE PARK 510(k) STATEMENT
PERTH, AUSTRALIA 6017
DEVICE: GE MOBILE DISCOVERY ST PET CT IMAGING SYSTEM
GENERAL ELECTRIC CO. 510(k) NO: K030199(SPECIAL)
ATTN: DAVID DUERSTELER PHONE NO : 262-312-7029
P.O. BOX 414 SE DECISION MADE: 11-FEB-03
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
GIVEN IMAGING LTD. 510(k) NO: K022980(TRADITIONAL)
ATTN: SHOSHANA (SHOS) FRIEDMAN PHONE NO : 972 490 97784
NEW INDUSTRIAL PARK SE DECISION MADE: 27-FEB-03
P.O. BOX 258 510(k) SUMMARY AVAILABLE FROM FDA
YOQNEAM, ISRAEL 20692
DEVICE: GOLDWAY DIGITAL VIDEO COLPOSCOPE IMAGING SYSTEM, MODEL #SLC-2000
GOLDWAY US, INC. 510(k) NO: K021153(TRADITIONAL)
ATTN: Y. JUSTIN CHEN PHONE NO : 408-286-8933
12 SOUTH FIRST STREET, SE DECISION MADE: 10-FEB-03
SUITE 1205 510(k) SUMMARY AVAILABLE FROM FDA
SAN JOSE, CA 95113
DEVICE: ESSEX ASPIRATION/IRRIGATION INSTRUMENT WITH POSITIONING GUIDE, M
GUIDANT CARDIAC SURGERY 510(k) NO: K023630(TRADITIONAL)
ATTN: RON ALLEN PHONE NO : 408-845-1913
3200 LAKESIDE DR. SE DECISION MADE: 20-FEB-03
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEM
GUIDANT CARDIAC SURGERY 510(k) NO: K024071(SPECIAL)
ATTN: DEBBIE COGAN PHONE NO : 408-845-1910
3200 LAKESIDE DR. SE DECISION MADE: 14-FEB-03
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JASUN, MODELS DT-01F AND DT-11F
HANGZHOU HUA'AN MEDICAL & HEALTH I510(k) NO: K030361(TRADITIONAL)
ATTN: TING LU PHONE NO : 847-991-9239
4960 TAMARACK DR. SE DECISION MADE: 21-FEB-03
BARRINGTON, IL 60010 510(k) STATEMENT
DEVICE: SAMARITAN AED, MODEL SAM-01
HEARTSINE TECHNOLOGIES INC 510(k) NO: K023854(TRADITIONAL)
ATTN: WILLIAM J SMIRLES PHONE NO : 847-317-0926
25892 JAMON LANE SE DECISION MADE: 14-FEB-03
MISSION VIEJO, CA 92691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLATELETWORKS, MODELS PW-A, PW-C
HELENA LABORATORIES 510(k) NO: K023761(TRADITIONAL)
ATTN: PATRICIA FRANKS PHONE NO : 409-842-3714
1530 LINDBERGH DR. SE DECISION MADE: 14-FEB-03
PO BOX 752 510(k) STATEMENT
BEAUMONT, TX 77704
DEVICE: SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389
HELENA LABORATORIES 510(k) NO: K024162(TRADITIONAL)
ATTN: ERIC PETERSEN PHONE NO : 409-842-3714
1530 LINDBERGH DR. SE DECISION MADE: 19-FEB-03
BEAUMONT, TX 77704 510(k) STATEMENT
DEVICE: AUTOMED 3000 INFUSION PUMP
HELP TECHNOLOGIES 510(k) NO: K023863(TRADITIONAL)
ATTN: ROBERT J BARD PHONE NO : 949-235-0545
24312 ARMADA DR. SE DECISION MADE: 07-FEB-03
DANA POINT, CA 92629 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTOMED 3200 INFUSION PUMP
HELP TECHNOLOGIES 510(k) NO: K023973(TRADITIONAL)
ATTN: ROBERT J BARD PHONE NO : 949-235-0545
24312 ARMADA DR. SE DECISION MADE: 27-FEB-03
DANA POINT, CA 92629 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PALABOND
HERAEUS KULZER GMBH & CO. KG 510(k) NO: K022251(ABBREVIATED)
ATTN: K. D. KUHN PHONE NO : 49 608 1959264
GRUNER WEG 11 SE DECISION MADE: 26-FEB-03
HANAU, GERMANY D-63450 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DURACON CS LIPPED EXTRA SMALL TIBIAL INSERT
HOWMEDICA OSTEONICS CORP. 510(k) NO: K023724(TRADITIONAL)
ATTN: MARGARET F CROWE PHONE NO : 201-831-5580
59 ROUTE 17 SE DECISION MADE: 03-FEB-03
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYDROPURE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM; HYDROPUR
HYDROPURE SYSTEMS, INC. 510(k) NO: K022747(TRADITIONAL)
ATTN: ROBERT V PRICE PHONE NO : 407-428-9377
3319 BARTLETT BLVD. SE DECISION MADE: 11-FEB-03
ORLANDO, FL 32817 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665G
IGC-MEDICAL ADVANCES, INC. 510(k) NO: K023848(TRADITIONAL)
ATTN: R. JERRY FROHLICH PHONE NO : 414-258-3808
10437 INNOVATION DRIVE SE DECISION MADE: 14-FEB-03
MILWAUKEE, WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAVIGUS II TRAJECTORY GUIDE WITH VERIFICATION RETICULES
IMAGE-GUIDED NEUROLOGICS, INC. 510(k) NO: K023949(TRADITIONAL)
ATTN: DAVID M LEE PHONE NO : 321-309-8237
2290 W. EAU GALLIE BLVD SE DECISION MADE: 25-FEB-03
MELBOURNE, FL 32935 510(k) STATEMENT
DEVICE: THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM
IMPLEX CORP. 510(k) NO: K023882(TRADITIONAL)
ATTN: ROBERT POGGIE PHONE NO : 201-818-1800
80 COMMERCE DR. SE DECISION MADE: 19-FEB-03
ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SABER TECH IMPLANTS SYSTEM
IMTEC CORP. 510(k) NO: K024044(TRADITIONAL)
ATTN: J BRAD VANCE PHONE NO : 580-223-4456
2401 NORTH COMMERCE SE DECISION MADE: 21-FEB-03
ARDMORE, OK 73401 510(k) STATEMENT
DEVICE: HEMOSIL FACTOR VII DEFICIENT PLASMA
INSTRUMENTATION LABORATORY CO. 510(k) NO: K024082(TRADITIONAL)
ATTN: CAROL MABLE PHONE NO : 781-861-4467
113 HARTWELL AVENUE SE DECISION MADE: 12-FEB-03
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIORAPID MONONUCLEOSIS
INSTRUMENTATION LABORATORY CO. 510(k) NO: K030215(TRADITIONAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
113 HARTWELL AVE. SE DECISION MADE: 24-FEB-03
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HERMETIC PLUS EXTERNAL CSF DRAINAGE SYSTEMS, INS-8301,INS-8302,I
INTEGRA LIFESCIENCES CORP. 510(k) NO: K030289(SPECIAL)
ATTN: DONNA WALLACE PHONE NO : 609-936-2397
311 ENTERPRISE DRIVE SE DECISION MADE: 26-FEB-03
PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TWLIGHT, MODEL ISP 9600
INVACARE CORP. 510(k) NO: K022642(TRADITIONAL)
ATTN: RAE ANN FARROW PHONE NO : 440-329-6000
ONE INVACARE WAY SE DECISION MADE: 11-FEB-03
ELYRIA, OH 44036 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALBUMIN COBALT BINDING TEST (ACB TEST)
ISCHEMIA TECHNOLOGIES, INC. 510(k) NO: K023824(TRADITIONAL)
ATTN: PETER CROSBY PHONE NO : 720-540-0200
4600 WEST 60TH AVENUE SE DECISION MADE: 14-FEB-03
ARVADA, CO 80003 510(k) STATEMENT
DEVICE: 4 SEASONS
IVOCLAR VIVADENT, INC. 510(k) NO: K024094(TRADITIONAL)
ATTN: DONNA MARIE HARTNETT PHONE NO : 716-691-2260
175 PINEVIEW DR. SE DECISION MADE: 14-FEB-03
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: MARK I THERMAL IMAGER
IX-DR, INC. 510(k) NO: K023925(TRADITIONAL)
ATTN: WILLIAM J O'NEILL PHONE NO : 800-736-9405
120 STATE SE DECISION MADE: 11-FEB-03
HOWELL, MI 48843 510(k) STATEMENT
DEVICE: HTS COIL
JOCKEY CLUB MRI ENGINEERING CENTER510(k) NO: K022863(TRADITIONAL)
ATTN: EDWARD S YANG PHONE NO : 852 229 30324
POKFULAM ROAD SE DECISION MADE: 04-FEB-03
UNIVERSITY OF HONG KONG 510(k) STATEMENT
HONG KONG, HONG KONG
DEVICE: ACTISORB SILVER 220 ANTIMICROBIAL BINDING DRESSING
JOHNSON & JOHNSON MEDICAL, LTD. 510(k) NO: K022483(TRADITIONAL)
ATTN: PATRICIA FLOOD PHONE NO : 908-218-2893
ROUTE 22 WEST SE DECISION MADE: 03-FEB-03
P.O. BOX 151 510(k) SUMMARY AVAILABLE FROM FDA
SOMERVILLE, NJ 08876
DEVICE: QUANDROX SAFELINE HOLLOW FIBER MEMBRANE OXYGENATOR, MODEL HMO 20
JOSTRA AG 510(k) NO: K030264(SPECIAL)
ATTN: KATRIN SCHWENKGLENKS PHONE NO : 497 478 9210
HECHINGER STRASSE 38 SE DECISION MADE: 26-FEB-03
HIRRLINGEN, GERMANY 72145 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D,
KAMIYA BIOMEDICAL CO. 510(k) NO: K023828(TRADITIONAL)
ATTN: BRIAN SCHLIESMAN PHONE NO : 206-575-8068
910 INDUSTRY DR. SE DECISION MADE: 04-FEB-03
SEATTLE, WA 98188-3412 510(k) STATEMENT
DEVICE: AUTOCON II 200 ELECTROSURGICAL GENERATOR
KARL STORZ ENDOSCOPY 510(k) NO: K023924(TRADITIONAL)
ATTN: JAMES A LEE PHONE NO : 310-338-8100
600 CORPORATE POINTE SE DECISION MADE: 21-FEB-03
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WINGED NEEDLE SETS WITH AN ANTINEEDLE STICK PROTECTOR
KAWASUMI LABORATORIES, INC. 510(k) NO: K023917(TRADITIONAL)
ATTN: DONALD R STONE PHONE NO : 202-778-9067
1800 MASSACHUSETTS AVE. SE DECISION MADE: 26-FEB-03
N.W. SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20036
DEVICE: AIROCIDE TI02
KES SCIENCE & TECHNOLOGY, INC 510(k) NO: K023830(TRADITIONAL)
ATTN: JOHN HAYMAN, JR PHONE NO : 770-427-6500
3625 KENNESAW N.INDUSTRIAL PKY SE DECISION MADE: 04-FEB-03
KENNESAW, GA 30144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V.A.C. ABDOMINAL DRESSING
KINETIC CONCEPTS, INC. 510(k) NO: K022011(TRADITIONAL)
ATTN: JUDITH A HARBOUR PHONE NO : 210-255-4468
8023 VANTAGE DRIVE SE DECISION MADE: 26-FEB-03
P.O. BOX 659508 510(k) STATEMENT
SAN ANTONIO, TX 78265-9508
DEVICE: KOMPRESSOR SCREW SYSTEM
KINETIKOS MEDICAL, INC. 510(k) NO: K024233(TRADITIONAL)
ATTN: JOHN G SPAMPINATO PHONE NO : 858-558-2233
6005 HIDDEN VALLEY ROAD SE DECISION MADE: 06-FEB-03
CARLSBAD, CA 92009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIVERSAL TOTAL WRIST SYSTEM
KINETIKOS MEDICAL, INC. 510(k) NO: K030037(SPECIAL)
ATTN: JOHN SPAMPINATO PHONE NO : 858-558-2233
6005 HIDDEN VALLEY ROAD SE DECISION MADE: 05-FEB-03
SUITE 180 510(k) SUMMARY AVAILABLE FROM FDA
CARLSBAD, CA 92009
DEVICE: CLEARFIL SE BOND PLUS
KURARAY MEDICAL INC. 510(k) NO: K023842(TRADITIONAL)
ATTN: MASAYA SASAKI PHONE NO : 212-986-2230
101 EAST 52ND STREET, 26TH FL. SE DECISION MADE: 11-FEB-03
NEW YORK, NY 10022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LAERDAL PAEDIATRIC POCKET MASK, MODEL 820050
LAERDAL MEDICAL A/S 510(k) NO: K023805(SPECIAL)
ATTN: MAGNE STEINSET PHONE NO : 47 51 511700
TANKE SVILANDSGATE 30 SE DECISION MADE: 11-FEB-03
STAVANGER, NORWAY 4002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STEERABLE GUIDEWIRE
LAKE REGION MFG., INC. 510(k) NO: K022813(TRADITIONAL)
ATTN: KAREN MORTENSEN PHONE NO : 952-448-5111
340 LAKE HAZELTINE DR. SE DECISION MADE: 14-FEB-03
CHASKA, MN 55318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTILOCK IMPLANTABLE ACCESS PORT, MODELS #1700-01, 1700-02, 1700
LEMAITRE VASCULAR, INC. 510(k) NO: K021580(TRADITIONAL)
ATTN: JAMES ASHBY PHONE NO : 781-221-2266
26 RAY AVENUE SE DECISION MADE: 12-FEB-03
BURLINGTON, MA 01803 510(k) STATEMENT
DEVICE: TAI-CHI AND MASTER ACUPUNCTURE NEEDLES
LHASA MEDICAL, INC. 510(k) NO: K023787(SPECIAL)
ATTN: KYUNG P RIIHIMAKI PHONE NO : 781-335-5288
234 LIBBEY PKWY. SE DECISION MADE: 14-FEB-03
WEYMOUTH, MA 02189 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONE TOUCH ULTRA AND ONE TOUCH INDUO BLOOD GLUCOSE MONITORING SYS
LIFESCAN, INC. 510(k) NO: K024194(TRADITIONAL)
ATTN: MARY ELLEN HOLDEN PHONE NO : 408-942-3589
1000 GIBRALTAR DR. SE DECISION MADE: 07-FEB-03
MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUNEAU STERILE TONOMETER SEPARATION PRISMS
LUNEAU SA 510(k) NO: K023838(TRADITIONAL)
ATTN: JEAN N YOUNG PHONE NO : 330 237 252525
BP 252 SE DECISION MADE: 20-FEB-03
CHARTRES CEDEX, FRANCE 28005 510(k) STATEMENT
DEVICE: MACROPORE SURGICAL BARRIER FILM
MACROPORE BIOSURGERY, INC. 510(k) NO: K023643(TRADITIONAL)
ATTN: KENNETH K KLEINHENZ PHONE NO : 858-458-0900
6740 TOP GUN ST. SE DECISION MADE: 21-FEB-03
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMORRHAGE OCCLUDER PIN (HOP), MODEL 337-247
MARINA MEDICAL INSTRUMENTS, INC. 510(k) NO: K023725(TRADITIONAL)
ATTN: JAY MANSOUR PHONE NO : 678-908-8180
1308 MORNINGSIDE PARK DR SE DECISION MADE: 03-FEB-03
ALPHARETTA, GA 30022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAFESTEP SAFETY DENTAL CARTRIDGE INJECTOR, MODEL 33-00000-1
MDC RESEARCH LTD. 510(k) NO: K022959(TRADITIONAL)
ATTN: CAROL PATTERSON PHONE NO : 949-462-0900
21911 ERIE LANE SE DECISION MADE: 05-FEB-03
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MSI I2010 DUAL PLACE HYPERBARIC CHAMBER
MECHIDYNE SYSTEMS, INC. 510(k) NO: K022214(TRADITIONAL)
ATTN: AUDREY L AARON PHONE NO : 281-550-2078
P.O. BOX 840661 SE DECISION MADE: 26-FEB-03
HOUSTON, TX 77284-0661 510(k) STATEMENT
DEVICE: MEDCOMP SC4
MEDCOMP 510(k) NO: K022678(TRADITIONAL)
ATTN: FLORENCE A CAIKOSKI PHONE NO : 215-256-4201
1499 DELP DR. SE DECISION MADE: 24-FEB-03
HARLEYSVILLE, PA 19438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZEPHIR ANTERIOR CERVICAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K030327(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 26-FEB-03
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERTE-SPAN SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K024049(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PL. SE DECISION MADE: 26-FEB-03
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO TSRH SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K030285(SPECIAL)
ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PL. SE DECISION MADE: 25-FEB-03
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STEALTHSTATION SYSTEM ADVANCED CONTOUR REGISTRATION SOFTWARE MOD
MEDTRONIC SURGICAL NAVIGATION TECH510(k) NO: K030106(SPECIAL)
ATTN: VICTORIA G RENDON PHONE NO : 720-890-3200
826 COAL CREEK CIRCLE SE DECISION MADE: 12-FEB-03
LOUISVILLE, CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MCPULSE
MERIDIAN CO., LTD. 510(k) NO: K023238(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 19-FEB-03
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MERIT MEDICAL 1-ML SYRINGE
MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K024052(ABBREVIATED)
ATTN: STEPHANIE A ERSKINE PHONE NO : 801-208-4349
1600 WEST MERIT PKWY. SE DECISION MADE: 21-FEB-03
SOUTH JORDAN, UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMFORTKONE KERATOCONUS ASPHERIC (HYBUFOCON A, FILOFILCON A, PEM
METRO OPTICS, INC. 510(k) NO: K024164(TRADITIONAL)
ATTN: DEANNA WERBER PHONE NO : 970-243-5490
623 GLACIER DRIVE SE DECISION MADE: 12-FEB-03
GRAND JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCOUSONIC PLUS, MODEL AP-170
METRON MEDICAL AUSTRALIA P/L 510(k) NO: K030410(SPECIAL)
ATTN: DAVE TOMAN PHONE NO : 613 977 51234
57 ASTER AVE. SE DECISION MADE: 20-FEB-03
CARRUM DOWNS, VICTORIA, AUSTRALIA 510(k) STATEMENT
DEVICE: SILBERG T.P.S., TISSUE PREPARATION SYSTEM, MODEL ME 800
METTLER ELECTRONICS CORP. 510(k) NO: K023083(ABBREVIATED)
ATTN: ROBERT E FLEMING PHONE NO : 800-854-9305
1333 SOUTH CLAUDINA ST. SE DECISION MADE: 28-FEB-03
ANAHEIM, CA 92805 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, MODELS 105-5065 AND
MICRO THERAPEUTICS, INC. 510(k) NO: K024118(SPECIAL)
ATTN: BILL HYATT PHONE NO : 949-837-3700
2 GOODYEAR SE DECISION MADE: 03-FEB-03
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRI PRIMIDONE CALIBRATORS
MICROGENICS CORP. 510(k) NO: K023780(TRADITIONAL)
ATTN: LAKSHMI ANNE PHONE NO : 510-979-5023
46360 FREMONT BLVD. SE DECISION MADE: 10-FEB-03
FREMONT, CA 94538 510(k) STATEMENT
DEVICE: SCLERAL PLUGS, 19 AND 20 GAUGE
MICROVISION, INC. 510(k) NO: K022186(TRADITIONAL)
ATTN: LEONARD KASTRILEVICH PHONE NO : 603-474-5566
34 FOLLY MILL RD. SUITE 200 SE DECISION MADE: 26-FEB-03
P.O. BOX 1651 510(k) SUMMARY AVAILABLE FROM FDA
SEABROOK, NH 03874-1651
DEVICE: MINOLTA PULSOX-2
MINOLTA CO., LTD. 510(k) NO: K021469(TRADITIONAL)
ATTN: NANCI DEXTER PHONE NO : 303-359-9791
2703 JOSEPHINE STREET SE DECISION MADE: 12-FEB-03
DENVER, CO 80205 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE BI-POLAR CABLE
MODERN MEDICAL EQUIPMENT MFG., LTD510(k) NO: K023966(TRADITIONAL)
ATTN: ROGER STRUBE PHONE NO : 804-353-7160
1705 DABNEY ROAD SE DECISION MADE: 27-FEB-03
RICHMOND, VA 23230 510(k) STATEMENT
DEVICE: ALLON 2001 VERSION 5
MTRE ADVANCED TECHNOLOGY LTD. 510(k) NO: K024128(SPECIAL)
ATTN: DOUGLAS RASH PHONE NO : 513-897-2868
6052 WILMINGTON PIKE #225 SE DECISION MADE: 10-FEB-03
CENTERVILLE, OH 45459 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NELLCOR INDGO MANUAL RESUSCITATOR
NELLCOR PURITAN BENNETT, INC. 510(k) NO: K023494(SPECIAL)
ATTN: GINA TO PHONE NO : 925-463-4427
4280 HACIENDA DR. SE DECISION MADE: 07-FEB-03
PLEASANTON, CA 94588-2719 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSURGICAL BIPOLAR HANDPIECE
NEOMEDIX CORP. 510(k) NO: K024304(TRADITIONAL)
ATTN: SOHEILA MIRHASEMI PHONE NO : 949-248-7029
27452 CALLE ARROYO SE DECISION MADE: 25-FEB-03
SAN JUAN CAPISTRANO, CA 92675-2748510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: NESS CHILDREN SYSTEM
NESS-NEUROMUSCULAR ELECTRICAL STIM510(k) NO: K024279(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5910
555 13TH STREET, N.W. SE DECISION MADE: 05-FEB-03
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNAMPS2
NEUROSCAN 510(k) NO: K023771(ABBREVIATED)
ATTN: ELVIRA GARCIA PHONE NO : 915-845-5600
7850 PASEO DEL NORTE SE DECISION MADE: 06-FEB-03
SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA
EL PASO, TX 79912
DEVICE: NEXUS INJECTION SITE (NIS), MODEL NIS-1
NEXUS MEDICAL, LLC 510(k) NO: K024363(TRADITIONAL)
ATTN: JAMIE ABOURCHED PHONE NO : 919-841-0315
11428 LOSTWOOD LANE SE DECISION MADE: 19-FEB-03
SUITE B 510(k) STATEMENT
RALEIGH, NC 27614
DEVICE: NOBEL PERFECT IMPLANT SYSTEM
NOBEL BIOCARE USA, INC. 510(k) NO: K030257(SPECIAL)
ATTN: ELIZABETH J MASON PHONE NO : 714-282-4800
22715 SAVI RANCH PKWY. SE DECISION MADE: 10-FEB-03
YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NPAC MULTI-USE EAR THERMOMETER, MODELS TD 600,610,620,630,602,61
NORM PACIFIC AUTOMATION CORP. 510(k) NO: K030126(SPECIAL)
ATTN: CHI-CHU WU CHEN PHONE NO : 886 357 85853
3F, NO. 31, HU-PIN ROAD #1 SE DECISION MADE: 07-FEB-03
SBIP 510(k) STATEMENT
HSIN-CHU, CHINA (TAIWAN)
DEVICE: DUAL YELLOW LASER, MODEL D10B
NORSELD PTY., LTD. 510(k) NO: K023899(TRADITIONAL)
ATTN: ROGER W BARNES PHONE NO : 501-525-8612
342 SUNSET BAY ROAD SE DECISION MADE: 20-FEB-03
HOT SPRINGS, AR 71913 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114)
OLYMPUS AMERICA, INC. 510(k) NO: K030045(TRADITIONAL)
ATTN: MICHAEL CAMPBELL PHONE NO : 972-556-9697
3131 WEST ROYAL LANE SE DECISION MADE: 21-FEB-03
IRVING, TX 75063-3104 510(k) STATEMENT
DEVICE: OLYMPUS FERRITIN REAGENT
OLYMPUS AMERICA, INC. 510(k) NO: K030124(SPECIAL)
ATTN: MICHAEL CAMPBELL PHONE NO : 972-556-9697
3131 WEST ROYAL LANE SE DECISION MADE: 06-FEB-03
IRVING, TX 75063-3104 510(k) STATEMENT
DEVICE: OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM & ITS ASSOCIATED ACCESSORI
OLYMPUS OPTICAL CO., LTD. 510(k) NO: K021852(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688
TWO CORPORATE CENTER DRIVE SE DECISION MADE: 11-FEB-03
MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTSTITCH M-CONNECTOR, MODEL OM-8005; SMARTSTITCH ACTUATION HA
OPUS MEDICAL, INC. 510(k) NO: K023843(TRADITIONAL)
ATTN: JAMES W HART PHONE NO : 949-234-0400
27127 CALLE ARROYO, SUITE 1924 SE DECISION MADE: 14-FEB-03
SAN JUAN CAPISTRANO, CA 92675 510(k) STATEMENT
DEVICE: DISTRACTION OSTEOGENESIS ROD APPLIANCES, MODELS 1, 2, AND 3
ORAL OSTEODISTRACTION, L.P. 510(k) NO: K014001(TRADITIONAL)
ATTN: ARTHUR WARD PHONE NO : 813-645-2855
962 ALLEGRO LANE SE DECISION MADE: 04-FEB-03
APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFESTENT LP SDS BILIARY ENDOPROSTHESIS
ORBUS MEDICAL TECHNOLOGIES 510(k) NO: K023248(TRADITIONAL)
ATTN: JIM CLOSSICK PHONE NO : 954-730-0711
5363 N.W. 35TH AVE. SE DECISION MADE: 11-FEB-03
FT. LAUDERDALE, FL 33309-6315 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEMPTELLER INFARED EAR THERMOMETERS, MODEL CT-31/31DX/32/32DX
ORIENTAL SYSTEM TECHNOLOGY, INC. 510(k) NO: K030299(SPECIAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511
55 NORTHERN BLVD SE DECISION MADE: 25-FEB-03
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: MODIFICATION TO VITROS IMMUNDODIAGNOSTIC PRODUCTS TROPONIN I REA
ORTHO-CLINICAL DIAGNOSTICS 510(k) NO: K024193(TRADITIONAL)
ATTN: ANN M QUINN PHONE NO : 585-453-4152
100 INDIGO CREEK DRIVE SE DECISION MADE: 21-FEB-03
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAVITRACK SYSTEM TOTAL HIP REPLACEMENT,MODEL 900.200
ORTHOSOFT, INC. 510(k) NO: K022364(TRADITIONAL)
ATTN: CHRISTOPHER MCLEAN PHONE NO : 514 861 4074
75 QUEEN ST., SUITE 3300 SE DECISION MADE: 04-FEB-03
MONTREAL, QUEBEC, CANADA H3C 2N6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OXYBOX SYSTEM
OXYFAST CORPORATION 510(k) NO: K023456(TRADITIONAL)
ATTN: MELVYN BURKE PHONE NO : 216-795-3060
11000 CEDAR AVE # 449 SE DECISION MADE: 24-FEB-03
CLEVELAND, OH 44106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FASSIRE-DUVAL TELESCOPIC IM SYSTEM
PEGA MEDICAL INC. 510(k) NO: K020885(TRADITIONAL)
ATTN: ARIEL R DUJOVNE PHONE NO : 514 322 8560 X241
9260 VIAU BLVD. SE DECISION MADE: 06-FEB-03
ST-LEONARD (MONTREAL) 510(k) SUMMARY AVAILABLE FROM FDA
QUEBEC, CANADA H1R 2V8
DEVICE: PMH 1000 HEATED HUMIDIFIER
PEGASUS RESEARCH CORP. 510(k) NO: K013856(TRADITIONAL)
ATTN: KENNETH G MILLER PHONE NO : 714-541-8322
1714 SOUTH LYON ST. SE DECISION MADE: 21-FEB-03
SANTA ANA, CA 92705 510(k) STATEMENT
DEVICE: EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE
PENTAX PRECISION INSTRUMENT CORP. 510(k) NO: K023401(TRADITIONAL)
ATTN: PAUL SILVA PHONE NO : 845-365-0700
30 RAMLAND RD. SE DECISION MADE: 11-FEB-03
ORANGEBURG, NY 10962 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUNG NODULE ASSESSMENT AND COMPARISON OPTION
PHILIPS MEDICAL SYSTEMS(CLEVELAND)510(k) NO: K023785(TRADITIONAL)
ATTN: ROBERT L TUROCY PHONE NO : 440-483-3528
595 MINER ROAD SE DECISION MADE: 10-FEB-03
HIGHLAND HEIGHTS, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFINION SOFTWARE FEATURES
PHILIPS MEDICAL SYSTEMS(CLEVELAND)510(k) NO: K024066(TRADITIONAL)
ATTN: DUANE PRASCHAN PHONE NO : 440-483-5743
595 MINER RD. SE DECISION MADE: 04-FEB-03
HIGHLAND HEIGHTS, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHILIPS AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEM, MODELS M272
PHILIPS MEDICAL SYSTEMS, INC. 510(k) NO: K023931(TRADITIONAL)
ATTN: MARKUS STACHA PHONE NO : 49 703 14632840
NEDERLAND B.V. SE DECISION MADE: 24-FEB-03
POSTBUS 10.000 510(k) SUMMARY AVAILABLE FROM FDA
DA BEST, NETHERLANDS 5680
DEVICE: PANORAMA ENHANCEMENTS
PHILIPS MEDICAL SYSTEMS, INC. 510(k) NO: K024042(TRADITIONAL)
ATTN: DUANE C PRASCHAN PHONE NO : 440-483-5743
595 MINER ROAD SE DECISION MADE: 04-FEB-03
HIGHLAND HGTS., OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE)
PLANMED OY 510(k) NO: K021945(TRADITIONAL)
ATTN: BOB PIENKOWSKI PHONE NO : 630-894-2200
100 NORTH GRAY AVE. SUITE A SE DECISION MADE: 21-FEB-03
ROSELLE, IL 60172 510(k) STATEMENT
DEVICE: 1ST RESPONSE INTERMEDIATE MANUAL RESUSCITATOR
PORTEX, INC. 510(k) NO: K023793(TRADITIONAL)
ATTN: CINDY ENGELHARDT PHONE NO : 603-352-3812
10 BOWMAN DR. SE DECISION MADE: 11-FEB-03
KEENE, NH 03431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTIPLE NITRILE EXAMINATION GLOVES (POWDERED)
PT. SMART GLOVE INDONESIA 510(k) NO: K022814(TRADITIONAL)
ATTN: FOO KHON PU PHONE NO : 006 261 4532926
KAWASAN INDUSTRI MEDAN STAR J1 SE DECISION MADE: 19-FEB-03
RAYA MEDAN-LUBUK PAKAM KM.19 510(k) STATEMENT
TG MORAWA-DELI SERDANG UTARA, INDONESIA 20362
DEVICE: MULTIPLE PATIENT EXAMINATION GLOVES POWDERED LATEX
PT. SMART GLOVE INDONESIA 510(k) NO: K022815(TRADITIONAL)
ATTN: FOO KHON PU PHONE NO : 006 261 4532984
KAWASAN INDUSTRI MEDAN STAR J1 SE DECISION MADE: 13-FEB-03
RAYA MEDAN-LUBUK PAKAM KM.19 510(k) STATEMENT
TG MORAWA-DELI SERDANG UTARA, INDONESIA 20362
DEVICE: POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
PT. SMART GLOVE INDONESIA 510(k) NO: K030112(TRADITIONAL)
ATTN: FOO KHON PU PHONE NO : 006 261 4532984
KAWASAN INDUSTRI MEDAN STAR J1 SE DECISION MADE: 27-FEB-03
RAYA MEDAN-LUBUK PAKAM KM.19 510(k) STATEMENT
TG MORAWA-DELI SERDANG UTARA, INDONESIA 20362
DEVICE: NITRILE POWDER FREE EXAM GLOVE, WITH PEPPERMINT FLAVOR
PT. SMART GLOVE INDONESIA 510(k) NO: K030406(TRADITIONAL)
ATTN: FOO KHON PU PHONE NO : 006 261 4532926
KAWASAN INDUSTRI MEDAN STAR J1 SE DECISION MADE: 27-FEB-03
RAYA MEDAN-LUBUK PAKAM KM.19 510(k) STATEMENT
TG MORAWA-DELI SERDANG UTARA, INDONESIA 20362
DEVICE: SERAQUEST ANTI-THYROID PEROXIDASE (TPO)
QUEST INTL., INC. 510(k) NO: K023593(TRADITIONAL)
ATTN: ROBERT A CORT PHONE NO : 305-948-8788
1938 N.E. 148TH TERRACE SE DECISION MADE: 06-FEB-03
NORTH MIAMI, FL 33181 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADIANT INNOVATION INC. INFRARED EAR THERMOMETER, MODELS TH1 SER
RADIANT INNOVATION, INC. 510(k) NO: K030324(SPECIAL)
ATTN: CHARLES CHANG PHONE NO : 011 886 35628708
NO. 40 LANE 19, BADE RD. SE DECISION MADE: 27-FEB-03
HSINCHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADIUS MICRO SNARE
RADIUS MEDICAL TECHNOLOGIES, INC. 510(k) NO: K022201(TRADITIONAL)
ATTN: DEBBIE IAMPIETRO PHONE NO : 508-435-9893
7 TIFFANY TRAIL SE DECISION MADE: 03-FEB-03
HOPKINTON, MA 01748 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RELIANT BTL 5000 PULS ELECTRICAL STIMULATION SYSTEM, RELIANT BTL
RELIANT TECHNOLOGIES, INC. 510(k) NO: K023050(TRADITIONAL)
ATTN: ANNE WORDEN PHONE NO : 925-426-8927
P.O. BOX 405 SE DECISION MADE: 14-FEB-03
ANGELS CAMP, CA 95221 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACIDIFIED COMPONENT CONCENTRATES FOR BICARBONATE DIALYSIS CONTAI
ROCKWELL MEDICAL TECHNOLOGIES, INC510(k) NO: K023985(TRADITIONAL)
ATTN: GERRY FRITZ PHONE NO : 248-960-9009
30142 WIXOM ROAD SE DECISION MADE: 28-FEB-03
WIXOM, MI 48393 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERFERENTIAL STIMULATOR, MODEL RTM1000
RYAN TELEMEDICINE 510(k) NO: K030254(TRADITIONAL)
ATTN: JIM KLETT PHONE NO : 949-645-4140
1011 BRIOSO DRIVE SE DECISION MADE: 26-FEB-03
COSTA MESA, CA 92627 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: FILM PROCESSOR, MODEL LIFE RAY PRO 1000
S.A.I.E.P. S.R.L. 510(k) NO: K023801(ABBREVIATED)
ATTN: DOUG HALE PHONE NO : 580-774-3623
2740-EAST FRONTAGE ROAD SE DECISION MADE: 12-FEB-03
WEATHERFORD, OK 73096-3658 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FILM PROCESSOR, MODEL LIFE RAY PRO 2500
S.A.I.E.P. S.R.L. 510(k) NO: K023825(ABBREVIATED)
ATTN: DOUG HALE PHONE NO : 580-774-3623
2700-EAST FRONTAGE ROAD SE DECISION MADE: 12-FEB-03
WEATHERFORD, OK 73096-3658 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERILE PATIENT POWDERFREE LATEX EXAMINATION GLOVES
SANREA HEALTHCARE PRIVATE LIMITED 510(k) NO: K023910(TRADITIONAL)
ATTN: JOSEPH J E PEREIRA PHONE NO : 91 484 422826
COCHIN SPECIAL ECONOMIC ZONE SE DECISION MADE: 11-FEB-03
KAKKANAD, COCHIN 510(k) STATEMENT
KERALA, INDIA 682037
DEVICE: POWDER FREE LATEX SURGEON'S GLOVES CONTAINS 50 MEGM OR LESS OF T
SANREA HEALTHCARE PRIVATE LIMITED 510(k) NO: K023912(TRADITIONAL)
ATTN: JOSEPH J E PEREIRA PHONE NO : 91 484 422826
COCHIN SPECIAL ECONOMIC ZONE SE DECISION MADE: 11-FEB-03
KAKKANAD, COCHIN 510(k) STATEMENT
KERALA, INDIA 682037
DEVICE: STERILE POWDERED LATEX PATIENT EXAMINATION GLOVES
SANREA HEALTHCARE PRIVATE LIMITED 510(k) NO: K023915(TRADITIONAL)
ATTN: JOSEPH J E PEREIRA PHONE NO : 91 484 422826
COCHIN SPECIAL ECONOMIC ZONE SE DECISION MADE: 11-FEB-03
KAKKANAD, COCHIN 510(k) STATEMENT
KERALA, INDIA 682037
DEVICE: SCIVOLUTIONS VARIOUS ANTIBACTERIAL BANDAGES
SCIVOLUTIONS, INC 510(k) NO: K020318(TRADITIONAL)
ATTN: ART WARD PHONE NO : 813-645-2855
962 ALLEGRO LANE SE DECISION MADE: 03-FEB-03
APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENORX ES-300
SENORX, INC. 510(k) NO: K030473(TRADITIONAL)
ATTN: AMY BOUCLY PHONE NO : 949-362-4800
11 COLUMBIA, SUITE A SE DECISION MADE: 26-FEB-03
ALISO VIEJO, CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: STEP-SAVER STAIRWAY CHAIRLIFT
SERVICES INDUSTRIELS SAVARIA, INC.510(k) NO: K024167(TRADITIONAL)
ATTN: STEPHEN BROPHY PHONE NO : 202-457-0300
1225 EYE STREET N.W. SE DECISION MADE: 06-FEB-03
SUITE 1150 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20005
DEVICE: B.07 STAIRWAY CHAIRLIFT
SERVICES INDUSTRIELS SAVARIA, INC.510(k) NO: K024345(TRADITIONAL)
ATTN: STEPHEN BROPHY PHONE NO : 202-457-0300
1225 EYE STREET N.W. SE DECISION MADE: 26-FEB-03
SUITE 1150 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20005
DEVICE: DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR
SHANGHAI PALOMAR MOUNTAIN INDUSTRI510(k) NO: K030148(TRADITIONAL)
ATTN: DANNY WANG PHONE NO : 862 157 727722
#1 BIYU RD., CANGQIAO TOWNSHIP SE DECISION MADE: 19-FEB-03
SONGJIANG SHANGHAI, CHINA 201600 510(k) STATEMENT
DEVICE: SIEMENS INFINITY SC 6002XL MODIFICATIONS
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K030313(SPECIAL)
ATTN: PENELOPE H GRECO PHONE NO : 978-907-7503
16 ELECTRONICS AVE. SE DECISION MADE: 11-FEB-03
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JAX
SMITH & NEPHEW, INC. 510(k) NO: K010555(TRADITIONAL)
ATTN: KIM P KELLY PHONE NO : 901-399-6566
1450 E. BROOKS ROAD SE DECISION MADE: 25-FEB-03
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JET-X HA COATED HALF PINS
SMITH & NEPHEW, INC. 510(k) NO: K023921(SPECIAL)
ATTN: DAVID HENLEY PHONE NO : 901-399-6487
1450 E. BROOKS ROAD SE DECISION MADE: 05-FEB-03
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW FEMORAL HEADS
SMITH & NEPHEW, INC. 510(k) NO: K024340(SPECIAL)
ATTN: KIM P KELLY PHONE NO : 901-396-2121
1450 E. BROOKS ROAD SE DECISION MADE: 26-FEB-03
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYONICS POWER CONTROL UNIT
SMITH & NEPHEW, INC. 510(k) NO: K030196(SPECIAL)
ATTN: JANICE HASELTON PHONE NO : 978-749-1494
150 MINUTEMAN ROAD SE DECISION MADE: 20-FEB-03
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNICONDYLAR FEMORAL COMPONENT
SMITH & NEPHEW, INC. 510(k) NO: K030301(SPECIAL)
ATTN: KIM KELLY PHONE NO : 901-399-6566
1450 E. BROOKS ROAD SE DECISION MADE: 25-FEB-03
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOHNIKS
SOHNIKS ENDOSCOPY, INC. 510(k) NO: K023783(TRADITIONAL)
ATTN: MARC HOSKINS PHONE NO : 651-452-4059
930 BLUE GENTIAN ROAD SE DECISION MADE: 07-FEB-03
SUITE 1400 510(k) SUMMARY AVAILABLE FROM FDA
EAGAN, MN 55121
DEVICE: SONOCALC
SONOMETRIC HEALTH, LLC 510(k) NO: K030223(TRADITIONAL)
ATTN: HELMUT FRITZ PHONE NO : 909-553-2650
1373 E. SKYLINE DR. SE DECISION MADE: 06-FEB-03
BOUNTIFUL, UT 84010 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: UP-DF500 FILMSTATION DIGITAL FILM IMAGER
SONY MEDICAL SYSTEMS 510(k) NO: K024188(TRADITIONAL)
ATTN: CYNTHIA A SINCLAIR PHONE NO : 508-643-0434
C/O MEDICAL DEVICE CONSULT,INC SE DECISION MADE: 04-FEB-03
49 PLAIN STREET 510(k) SUMMARY AVAILABLE FROM FDA
NORTH ATTLEBORO, MA 02760
DEVICE: ST. GEORGE TECHNOLOGY, INC PERFECTION PLUS DISPOSABLE PROPHY ANG
ST. GEORGE TECHNOLOGY, INC. 510(k) NO: K023953(TRADITIONAL)
ATTN: VERNON WATKINS PHONE NO : 910-397-0781
P.O. BOX 2849 SE DECISION MADE: 14-FEB-03
WILMINGTON, NC 28402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STARMATRIX POWDER FREE LATEX EXAMINATION GLOVES, WITH PROTEIN LA
STARMATRIX SDN BHD 510(k) NO: K023715(TRADITIONAL)
ATTN: NGAN BOON SENG PHONE NO : 603 339 6168
10, JALAN SS 1/26 SE DECISION MADE: 04-FEB-03
PETALING JAYA, SELANGOR, MALAYSIA 510(k) STATEMENT
DEVICE: STARTOX DRUG OF ABUSE SCREENING TEST (4)
STARPLEX SCIENTIFIC, INC. 510(k) NO: K022388(TRADITIONAL)
ATTN: FRAN WHITE PHONE NO : 978-927-3808
163 CABOT STREET SE DECISION MADE: 27-FEB-03
BEVERLY, MA 01915 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER XCEL ANCHOR SYSTEM
STRYKER ENDOSCOPY 510(k) NO: K023013(TRADITIONAL)
ATTN: ALISA MILLER PHONE NO : 408-754-2000
5900 OPTICAL CT. SE DECISION MADE: 26-FEB-03
SAN JOSE, CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUMMIT MEDICAL LTD "CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SET,
SUMMIT MEDICAL LTD. 510(k) NO: K024097(TRADITIONAL)
ATTN: NEIL R ARMSTRONG PHONE NO : 011 441 763222505
BUSINESS & TECHNOLOGY CENTRE SE DECISION MADE: 14-FEB-03
BESSEMER DRIVE 510(k) SUMMARY AVAILABLE FROM FDA
STEVENAGE HERTFORDSHIRE, UNITED KINGDOM SGI 2DX
DEVICE: CARBO/OPTIMED BRAND ACUPUNCTURE NEEDLES
SUZHOU SEN SEN MEDICAL SUPPLIES LT510(k) NO: K030190(TRADITIONAL)
ATTN: KEVIN LIU PHONE NO : 416 299 6643
4500 SHEPPARD AVE. EAST SE DECISION MADE: 21-FEB-03
UNIT #1, SCARBOROUGH 510(k) SUMMARY AVAILABLE FROM FDA
ONTARIO, CANADA
DEVICE: POLARIS DS
SYNERON MEDICAL LTD. 510(k) NO: K024064(TRADITIONAL)
ATTN: AMIR WALDMAN PHONE NO : 972 67 404616
POB 550 SE DECISION MADE: 10-FEB-03
YOKNEAM ELITE, ISRAEL 20692 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMALL TITANIUM WRIST FUSION PLATE
SYNTHES (USA) 510(k) NO: K023879(TRADITIONAL)
ATTN: LISA M BOYLE PHONE NO : 610-647-9700
1690 RUSSELL ROAD SE DECISION MADE: 05-FEB-03
POST OFFICE BOX 1766 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301
DEVICE: TEH LIN POWERED WHEELCHAIR, MODEL MDG-201
TEH LIN PROSTHETIC & ORTHOPAEDIC, 510(k) NO: K022696(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 3 5208829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 07-FEB-03
HSIN CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TERUMO SURGUARD SAFETY SYRINGE
TERUMO MEDICAL CORP. 510(k) NO: K024249(ABBREVIATED)
ATTN: BARBARA SMITH PHONE NO : 410-392-7231
125 BLUE BALL RD. SE DECISION MADE: 21-FEB-03
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JEROME GLASS RING
THE JEROME GROUP, INC. 510(k) NO: K023959(TRADITIONAL)
ATTN: BERNIE TATRO PHONE NO : 800-257-8440
305 HARPER DR. SE DECISION MADE: 21-FEB-03
MOORESTOWN, NJ 08057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLYMPUS ULTRASONIC SURGICAL SYSTEM
THE OLYMPUS OPTICAL CO. 510(k) NO: K021962(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688
TWO CORPORATE DRIVE SE DECISION MADE: 12-FEB-03
MELVILLE, NY 11747 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PATHWAY CTS2000 PELVIC FLOOR TRAINING SYSTEM
THE PROMETHEUS GROUP 510(k) NO: K023906(TRADITIONAL)
ATTN: HEATHER MAGOON PHONE NO : 603-749-0733
1 WASHINGTON ST., SUITE 303 SE DECISION MADE: 19-FEB-03
DOVER, NH 03820 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR/MODEL: WL-2206, WE
THERATECH, INC. 510(k) NO: K024100(TRADITIONAL)
ATTN: TONY C.S. CHANG PHONE NO : 886 422 972787
NO.5,ALLEY 5,LANG CHENG HSING, SE DECISION MADE: 25-FEB-03
CHUNG CHING RD,PEI TUN DIST. 510(k) SUMMARY AVAILABLE FROM FDA
TAICHUNG, CHINA (TAIWAN) R.O.C
DEVICE: THE THERATEST "EL-ANA PROFILES: ANTI-CENTROMERE
THERATEST LABORATORIES, INC. 510(k) NO: K024031(TRADITIONAL)
ATTN: MARIUS TEODORESCU PHONE NO : 630-627-6069
1111 N. MAIN STREET SE DECISION MADE: 06-FEB-03
LOMBARD, IL 60148 510(k) STATEMENT
DEVICE: EL-ANA PROFILES: ANTI-RIBOSOMAL PROTEIN P
THERATEST LABORATORIES, INC. 510(k) NO: K024151(TRADITIONAL)
ATTN: MARIUS TEODORESCU PHONE NO : 630-627-6069
1111 N. MAIN STREET SE DECISION MADE: 06-FEB-03
LOMBARD, IL 60148 510(k) STATEMENT
DEVICE: THERMACOOL TC SYSTEM
THERMAGE, INC. 510(k) NO: K030142(SPECIAL)
ATTN: PAMELA M BUCKMAN PHONE NO : 510-782-2286
4058 POINT EDEN WAY SE DECISION MADE: 03-FEB-03
HAYWARD, CA 94545-3721 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THOR DDII 830CL3 LASER SYSTEM
THOR INTL. 510(k) NO: K030226(TRADITIONAL)
ATTN: M. JOYCE HEINRICH PHONE NO : 713-734-4433
12101 CULLEN BLVD #A SE DECISION MADE: 10-FEB-03
HOUSTON, TX 77047 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TISSUELINK BIPOLAR FLOATING BALL DEVICE
TISSUELINK MEDICAL, INC. 510(k) NO: K022532(TRADITIONAL)
ATTN: VICKI S ANASTASI PHONE NO : 508-922-1622
ONE WASHINGTON CENTER SE DECISION MADE: 12-FEB-03
SUITE #400 510(k) SUMMARY AVAILABLE FROM FDA
DOVER, NH 03820
DEVICE: POWDERED VINYL EXAMINATION GLOVES
TOP GLOVE (ZHANGJIAGANG) CO. LTD. 510(k) NO: K024016(TRADITIONAL)
ATTN: LIM WEE CHAI PHONE NO : 008 651 258422860
3, ZHANGJIAGANG XI TANG ROAD SE DECISION MADE: 03-FEB-03
XI ZHANG TOWN, CHINA 215614 510(k) STATEMENT
DEVICE: TOP GLOVE VINYL EXAMINATION GLOVE
TOP GLOVE (ZHANGJIAGANG) CO. LTD. 510(k) NO: K024216(TRADITIONAL)
ATTN: LIM WEE CHAI PHONE NO : 008 651 258422860
3, ZHANGJIAGANG XI TANG ROAD SE DECISION MADE: 27-FEB-03
XI ZHANG TOWN, CHINA 215614 510(k) STATEMENT
DEVICE: ALOE VERA & VITAMIN E POWDERFREE LATEX EXAMINATION GLOVES
TOP GLOVE SDN. BHD. 510(k) NO: K023974(TRADITIONAL)
ATTN: LIM WEE CHAI PHONE NO : 603 339 21992
LOT 4968 JALAN TERATAI, BATU 6 SE DECISION MADE: 13-FEB-03
OFF JALAN MERU, 41050 KLANG 510(k) STATEMENT
SELANGOR, D.E., MALAYSIA 41050
DEVICE: TRUTEK SELECT MODEL TT-1001
TRUTEK, INC. 510(k) NO: K023510(TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 410-451-0639
P.O. BOX 4341 SE DECISION MADE: 04-FEB-03
CROFTON, MD 21114 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: TYTAN ELECTRONIC STETHOSCOPES (MODEL #600)
TYTAN MEDICAL CORP. 510(k) NO: K023637(TRADITIONAL)
ATTN: JENNIFER REICH PHONE NO : 928-773-9488
3892 SOUTH AMERICA WEST TRAIL SE DECISION MADE: 26-FEB-03
FLAGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ULTROID HEMORRHOID MANAGEMENT SYSTEM
ULTROID, LLC 510(k) NO: K030315(SPECIAL)
ATTN: RONALD R NEWTON PHONE NO : 775-841-4333
2230 DAMON RD. SE DECISION MADE: 27-FEB-03
CARSON CITY, NV 89701 510(k) STATEMENT
DEVICE: U2 ACETABULAR CUP
UNITED ORTHOPEDIC CORP. 510(k) NO: K022520(TRADITIONAL)
ATTN: JIANN-JONG LIAU PHONE NO : 886 3 5773351
57 PARK AVE. 2, SCIENCE PARK SE DECISION MADE: 25-FEB-03
HSINCHU, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEO III TX/RX QUADRATURE KNEE COIL; ALPHA III TX/RX QUADRATURE W
USA INSTRUMENTS, INC. 510(k) NO: K023982(TRADITIONAL)
ATTN: CHRISTIE SHUMAKER PHONE NO : 330-562-1000
1515 DANNER DRIVE SE DECISION MADE: 21-FEB-03
AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPIRIT III TOTALSENSE CARDIAC COIL
USA INSTRUMENTS, INC. 510(k) NO: K024187(TRADITIONAL)
ATTN: CHRISTIE SHUMAKER PHONE NO : 330-562-1000
1515 DANNER DRIVE SE DECISION MADE: 04-FEB-03
AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PREMIER III PHASED ARRAY CTL SPINE COIL
USA INSTRUMENTS, INC. 510(k) NO: K030042(TRADITIONAL)
ATTN: CHRISTIE SHUMAKER PHONE NO : 330-562-1000
1515 DANNER DRIVE SE DECISION MADE: 24-FEB-03
AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SNAP KOVER, MODEL 01-2020; SNAP KAPS, MODEL 03-KP09
VALUMED 510(k) NO: K023540(TRADITIONAL)
ATTN: THOMAS E COTTONE PHONE NO : 850-897-3321
1439 LIVE OAK STREET SE DECISION MADE: 04-FEB-03
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
NICEVILLE, FL 32578
DEVICE: PAXSCAN 4030 MEDICAL DIGITAL IMAGING SYSTEM
VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K024147(TRADITIONAL)
ATTN: LINDA S NASH PHONE NO : 650-424-6990
3100 HANSEN WAY SE DECISION MADE: 12-FEB-03
PALO ALTO, CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GELBFISH FLEX VASCULAR DILATOR
VASCUMETRIX, LLC 510(k) NO: K030260(SPECIAL)
ATTN: NICK RAIBLE PHONE NO : 480-807-6300
1058 N. HIGLEY ROAD #204 SE DECISION MADE: 20-FEB-03
MESA, AZ 85205 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VICTUS I.V. ADMINISTRATION SET, MODELS 27071 AND 27072
VICTUS, INC. 510(k) NO: K030246(TRADITIONAL)
ATTN: ILEANA YATES PHONE NO : 305-663-2129
4918 S.W. 74 CT. SE DECISION MADE: 26-FEB-03
MIAMI, FL 33155 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OBSERVER ULTRASOUND REPORTING AND IMAGING SYSTEM
VISION CHIPS, INC. 510(k) NO: K022877(TRADITIONAL)
ATTN: RONALD "JOCK" PHILIP PHONE NO : 949-362-0565
27111 ALISO CREEK RD, STE. 120 SE DECISION MADE: 05-FEB-03
ALISO VIEJO, CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WAKO L-TYPE GLUCOSE 2
WAKO CHEMICALS, USA, INC. 510(k) NO: K024281(TRADITIONAL)
ATTN: TONYA MALLORY PHONE NO : 804-271-7677
1600 BELLWOOD RD. SE DECISION MADE: 24-FEB-03
RICHMOND, VA 23237 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WAKO NEFA LINEARITY SET
WAKO CHEMICALS, USA, INC. 510(k) NO: K030065(TRADITIONAL)
ATTN: TONYA MALLORY PHONE NO : 800-992-9256
1600 BELLWOOD RD. SE DECISION MADE: 11-FEB-03
RICHMOND, VA 23237 510(k) STATEMENT
DEVICE: HEM-O-LOK XL CLIP
WECK 510(k) NO: K030311(SPECIAL)
ATTN: BRIAN YOUNG PHONE NO : 919-361-4041
2917 WECK DRIVE SE DECISION MADE: 26-FEB-03
RESEARCH TRIANGLE PARK, NC 27709 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WELCH ALLYN VITAL SIGN MONITOR WITH MP506
WELCH ALLYN, INC. 510(k) NO: K024005(SPECIAL)
ATTN: DAVID KLEMENTOWKI PHONE NO : 315-685-4100
4341 STATE STREET RD. SE DECISION MADE: 12-FEB-03
SKANEATELES FALLS, NY 13153-0220 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WIENER LAB COLINESTERASA AA
WIENER LABORATORIES S.A.I.C. 510(k) NO: K023992(TRADITIONAL)
ATTN: VIVIANA CETOLA PHONE NO : 54 341 4851982
2571 MAIPU SE DECISION MADE: 12-FEB-03
ROSARIO, SANTA FE, ARGENTINA 2000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WIENER LAB. BILIRUBINA DIRECT AA
WIENER LABORATORIES S.A.I.C. 510(k) NO: K024116(TRADITIONAL)
ATTN: VIVIANA CETILA PHONE NO : 341 432 9191
2944 RIOBAMBA SE DECISION MADE: 12-FEB-03
ROSARIO, ARGENTINA 2000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WILSON-COOK ENDOSCOPIC CLIPPING DEVICE
WILSON-COOK MEDICAL, INC. 510(k) NO: K023903(TRADITIONAL)
ATTN: MARGARET POSNER PHONE NO : 336-744-0157
4900 BETHANIA STATION RD. SE DECISION MADE: 20-FEB-03
WINSTON-SALEM, NC 27105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CATHETER CONNECTOR
WORLD METALS, INC, 510(k) NO: K023690(TRADITIONAL)
ATTN: MARTIN MITCHELL PHONE NO : 954-781-4604
1020 NE 27 AVE. SE DECISION MADE: 28-FEB-03
POMPANO BEACH, FL 33062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVANCE LESS CONFORMING TIBIAL COMPONENT
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K030193(SPECIAL)
ATTN: TIM CRABTREE PHONE NO : 901-867-4754
5677 AIRLINE RD. SE DECISION MADE: 20-FEB-03
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE LATEX EXAMINATION GLOVES, STERILE WITH PROTEIN CONTE
WRP ASIA PACIFIC SDN. BHD. 510(k) NO: K030157(TRADITIONAL)
ATTN: TERENCE LIM PHONE NO : 60 3 87061486
LOT1,JALAN3,KAWASAN PERUSAHAAN SE DECISION MADE: 19-FEB-03
BANDAR BARU SALAK TINGGI 510(k) SUMMARY AVAILABLE FROM FDA
SEPANG,SELANGOR DARUL EHSAN, MALAYSIA 43900
DEVICE: XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01
XENOTOPE DIAGNOSTICS, INC. 510(k) NO: K020595(TRADITIONAL)
ATTN: ROBIN J HELLEN PHONE NO : 818-709-5646
9418 LASAINE AVE. SE DECISION MADE: 20-FEB-03
NORTHRIDGE, CA 91325 510(k) STATEMENT
DEVICE: CLOCKMINI, MODEL DF301; CLOCKNAVI, MODEL DF311
YAMATO CORP. 510(k) NO: K023942(TRADITIONAL)
ATTN: CLAY ANSELMO PHONE NO : 303-832-8200
518 17TH STREET SE DECISION MADE: 24-FEB-03
SUITE 1350 510(k) SUMMARY AVAILABLE FROM FDA
DENVER, CO 80202
DEVICE: EVERGREEN NON-STERILE POWDERED NATURAL OR COLORED LATEX EXAMINAT
YTY INDUSTRY (MANJUNG) SDN. BHD. 510(k) NO: K024355(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 03-FEB-03
SPARKS, NV 89434-9550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERSYS BEADED FULLCOAT BOWED REVISION HIP PROSTHESIS
ZIMMER, INC. 510(k) NO: K030079(SPECIAL)
ATTN: FRED MCCLURE PHONE NO : 574-372-4294
P.O. BOX 708 SE DECISION MADE: 05-FEB-03
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 258
TOTAL WITH SUMMARIES 203
TOTAL WITH STATEMENTS 55
Updated December 26, 2007
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