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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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