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510(k)s Final Decisions Rendered for February 2002 |
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE) 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD 01-FEB-2002 THROUGH 28-FEB-2002 DEVICE: UNITE BONDING ADHESIVE 3M UNITEK 510(k) NO: K014142(TRADITIONAL) ATTN: L. MARLYN SCHEFF PHONE NO : 626-574-4496 2724 SOUTH PECK RD. SE DECISION MADE: 28-FEB-02 MONROVIA, CA 91016 510(k) STATEMENT DEVICE: A & D MEDICAL LIFESOURCE UA-781, UA781PC, & UA-781T DIGITAL BLOO A & D ENGINEERING, INC. 510(k) NO: K012472(TRADITIONAL) ATTN: JERRY WANG PHONE NO : 408-263-5333 1555 MCCANDLESS DR. SE DECISION MADE: 15-FEB-02 MILPITAS, CA 95035 510(k) STATEMENT DEVICE: AARON REUSABLE ELECTROSURGICAL ELECTRODE AARON MEDICAL INDUSTRIES 510(k) NO: K014201(TRADITIONAL) ATTN: RICHARD A KOZLOFF PHONE NO : 727-384-2323 7100 30TH AVE. NORTH SE DECISION MADE: 25-FEB-02 ST. PETERSBURG, FL 33710-2902 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOF-TACT DIABETES MANAGEMENT SYSYEM; SOF-TACT BLOOD GLUCOSE TEST ABBOTT LABORATORIES 510(k) NO: K012975(TRADITIONAL) ATTN: JANET S CONNOLLY PHONE NO : 781-276-6230 4-A CROSBY DR. SE DECISION MADE: 28-FEB-02 BEDFORD, MA 01730-1402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABX MICROS 60 HEMATOLOGY ANALYZER ABX DIAGNOSTICS 510(k) NO: K014203(TRADITIONAL) ATTN: TOM M PHILLIPS PHONE NO : 949-453-0500 34 BUNSEN DR. SE DECISION MADE: 28-FEB-02 IRVINE, CA 92618-4210 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~) ACULUX, , INC. 510(k) NO: K013511(TRADITIONAL) ATTN: KIM MARSH PHONE NO : 941-643-8023 273 SOUTH AIRPORT PULLING RD. SE DECISION MADE: 01-FEB-02 NAPLES, FL 34104 510(k) STATEMENT DEVICE: AOS CANNULATED BONE SCREW SYSTEM ADVANCED ORTHOPAEDIC SOLUTIONS 510(k) NO: K014185(TRADITIONAL) ATTN: PAUL DONER PHONE NO : 310-831-4433 333 WEST 6TH ST., SUITE 202 SE DECISION MADE: 13-FEB-02 SAN PEDRO, CA 90731 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERRAD CYCLESURE BIOLOGICAL INDICATOR ADVANCED STERILIZATION PRODUCTS 510(k) NO: K994055(TRADITIONAL) ATTN: KEVIN CORRIGAN PHONE NO : 949-453-6410 33 TECHNOLOGY DR. SE DECISION MADE: 13-FEB-02 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PEACE OF MIND HOME DRUG TEST ADVANTAGE DIAGNOSTICS CORP. 510(k) NO: K013778(TRADITIONAL) ATTN: JANIS FREESTONE PHONE NO : 650-569-3852 1201 DOUGLAS AVE. SE DECISION MADE: 07-FEB-02 REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS ADVEN MEDICAL 510(k) NO: K012675(TRADITIONAL) ATTN: MARK W ALDANA PHONE NO : 806-745-7718 1001 SLATON HWY. SE DECISION MADE: 12-FEB-02 LUBBOCK, TX 79404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS ADVEN MEDICAL 510(k) NO: K012676(TRADITIONAL) ATTN: MARK W ALDANA PHONE NO : 806-745-7718 1001 SLATON HWY. SE DECISION MADE: 04-FEB-02 LUBBOCK, TX 79404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS ADVEN MEDICAL 510(k) NO: K012694(TRADITIONAL) ATTN: MARK W ALDANA PHONE NO : 806-745-7718 1001 SLATON HWY. SE DECISION MADE: 04-FEB-02 LUBBOCK, TX 79404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED USED DISPOSABLE ENDOSCOPIC SCISSORS AND GRASPERS ADVEN MEDICAL 510(k) NO: K012696(TRADITIONAL) ATTN: MARK W ALDANA PHONE NO : 806-745-7718 1001 SLATON HWY. SE DECISION MADE: 04-FEB-02 LUBBOCK, TX 79404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXTORAL/TESCERA GLAZING RESIN, MODEL T-1804 AFP IMAGING CORP. 510(k) NO: K014144(TRADITIONAL) ATTN: DAVID VOZICK PHONE NO : 914-592-6100 250 CLEARBROOK RD. SE DECISION MADE: 07-FEB-02 ELMSFORD, NY 10523 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLEX 10 ACCESSORY FOR THE AFX MICROWAVE ABLATION SYSTEM AFX, INC. 510(k) NO: K013946(TRADITIONAL) ATTN: NANCY NORRIS PHONE NO : 510-651-7430 47929 FREMONT BOULEVARD SE DECISION MADE: 27-FEB-02 FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCANX AIR TECHNIQUES, INC. 510(k) NO: K013893(TRADITIONAL) ATTN: JOSEPH CAREY PHONE NO : 516-433-7676 70 CANTIAGUE ROCK RD. SE DECISION MADE: 01-FEB-02 HICKSVILLE, NY 11801 510(k) STATEMENT DEVICE: COMPLETE BRAND MULTI-PURPOSE SOLUTION ALLERGAN, INC. 510(k) NO: K013479(TRADITIONAL) ATTN: PAUL J NOWACKI PHONE NO : 714-246-6761 2525 DUPONT DRIVE SE DECISION MADE: 11-FEB-02 IRVINE, CA 92612 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPLETE BRAND MULTI-PURPOSE SOLUTION ALLERGAN, INC. 510(k) NO: K014202(TRADITIONAL) ATTN: PAUL J NOWACKI PHONE NO : 714-246-6761 2525 DUPONT DRIVE SE DECISION MADE: 20-FEB-02 IRVINE, CA 92612 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED HOT BIOPSY FORCEPS ALLIANCE MEDICAL CORP. 510(k) NO: K012607(TRADITIONAL) ATTN: DON SELVEY PHONE NO : 480-763-5300 10232 SOUTH 51ST. STREET SE DECISION MADE: 04-FEB-02 PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED AUTOSUTURE LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS ALLIANCE MEDICAL CORP. 510(k) NO: K012608(TRADITIONAL) ATTN: DON SELVEY PHONE NO : 480-763-5300 10232 SOUTH 51ST. STREET SE DECISION MADE: 14-FEB-02 PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED POLYPECTOMY SNARES ALLIANCE MEDICAL, INC. 510(k) NO: K012610(TRADITIONAL) ATTN: DON SELVEY PHONE NO : 480-763-5300 10232 SOUTH 51 STREET SE DECISION MADE: 19-FEB-02 PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APPLE MEDICAL MOBIUS ELASTIC RETRACTOR APPLE MEDICAL CORP. 510(k) NO: K014005(TRADITIONAL) ATTN: JOHN C PULFORD PHONE NO : 508-357-2700 28 LORD RD., UNIT 135 SE DECISION MADE: 15-FEB-02 MARLBORO, MA 01752 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: APPLIED GELPORT LAPAROSCOPIC HAND ACCESS DEVICE APPLIED MEDICAL RESOURCES CORP. 510(k) NO: K014047(TRADITIONAL) ATTN: ANIL BHALANI PHONE NO : 949-713-8000 22872 AVENIDA EMPRESSA SE DECISION MADE: 28-FEB-02 RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TROJAN CRYSTAL CLEAR LIQUID ARMKEL LLC 510(k) NO: K013614(TRADITIONAL) ATTN: STEPHEN C KOLAKOWSKY PHONE NO : 609-655-6308 P.O. BOX 1001 HALF ACRE RD SE DECISION MADE: 01-FEB-02 CRANBURY,, NJ 08512 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LASER SYSTEM YELLOWSTAR ASCLEPION-MEDITEC AG 510(k) NO: K013940(TRADITIONAL) ATTN: WILLIAM KELLEY PHONE NO : 2961 W. MAC ARTHUR BLVD. #133 SE DECISION MADE: 26-FEB-02 SANTA ANA, CA 92704 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE LIGHT HANDLE AND ADAPTOR ASPEN SURGICAL PRODUCTS, INC. 510(k) NO: K020304(TRADITIONAL) ATTN: ROY MELLING PHONE NO : 888-364-7004 7425 CLYDE PARK, SUITE G SE DECISION MADE: 14-FEB-02 GRAND RAPIDS, MI 49315-0404 510(k) STATEMENT DEVICE: SI ASCOPE ASTRON CLINICA LIMITED 510(k) NO: K011273(TRADITIONAL) ATTN: E.J. SMITH PHONE NO : 410-451-0639 PO BOX 4341 SE DECISION MADE: 20-FEB-02 CROFTON, MD 21114 510(k) STATEMENT DEVICE: SPHYGMOCOR PX MODEL SCOR-PX ATCOR MEDICAL PTY. LTD 510(k) NO: K012487(TRADITIONAL) ATTN: KIRSTEN PAULSON PHONE NO : 301-933-1914 1400 16TH STREET, NW SE DECISION MADE: 21-FEB-02 SUITE 400 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20036 DEVICE: PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251 ATOS MEDICAL AB 510(k) NO: K014102(SPECIAL) ATTN: EDDY ABERG PHONE NO : 464 151 9800 KRAFTGATAN 8 SE DECISION MADE: 21-FEB-02 HORBY, SWEDEN SE-242 22 510(k) STATEMENT DEVICE: TRELLIS INFUSION SYSTEM (10CM INFUSION LENGTH); TRELLIS INFUSION BACCHUS VASCULAR, INC. 510(k) NO: K013635(TRADITIONAL) ATTN: GREG MATHISON PHONE NO : 408-980-8300 3110 CORONADO DR. SE DECISION MADE: 11-FEB-02 SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HARVEY PV DRY STERILIZER, MODEL # ST127325; ST127320; ST127320-3 BARNSTEAD/THERMOLYNE CORP. 510(k) NO: K014174(TRADITIONAL) ATTN: MIA M WARE PHONE NO : 563-556-2241 P.O. BOX 797 SE DECISION MADE: 22-FEB-02 DUBUQUE, IA 52001 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM BAYER DIAGNOSTICS CORP. 510(k) NO: K012357(TRADITIONAL) ATTN: KENNETH T EDDS PHONE NO : 914-524-2446 511 BENEDICT AVE SE DECISION MADE: 28-FEB-02 TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BMC RADIO FREQUENCY PERFORATION GENERATOR, MODELS RFP-100-115 AN BAYLIS MEDICAL CO., INC. 510(k) NO: K013904(TRADITIONAL) ATTN: KRIS SHAH PHONE NO : 905 602 4875 5160 EXPLORER DRIVE, UNIT 33 SE DECISION MADE: 12-FEB-02 MISSISSAUGA, CANADA L4W-4T7 510(k) STATEMENT DEVICE: TORFLEX TRANSSEPTAL GUIDING SHEATH BAYLIS MEDICAL CO., INC. 510(k) NO: K013919(TRADITIONAL) ATTN: KRIS SHAH PHONE NO : 905 602 4875 5160 EXPLORER DRIVE, UNIT 33 SE DECISION MADE: 22-FEB-02 MISSISSAUGA, CANADA L4W-4T7 510(k) STATEMENT DEVICE: BCI 1621 OXIMETRY DATA MANAGEMENT PROGRAM BCI, INC. 510(k) NO: K013862(TRADITIONAL) ATTN: DONALD ALEXANDER PHONE NO : 262-542-3100 N7 W22025 JOHNSON ROAD SE DECISION MADE: 21-FEB-02 WAUKESHA, WI 53186 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BECKER BAND CRANIAL REMOLDING ORTHOSIS BECKER ORTHOPEDIC APPLIANCE CO. 510(k) NO: K013719(TRADITIONAL) ATTN: JAMES H CAMPBELL PHONE NO : 248-588-6961 635 EXECUTIVE DR. SE DECISION MADE: 05-FEB-02 TROY, MI 48083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR BECKMAN COULTER, INC. 510(k) NO: K014173(TRADITIONAL) ATTN: MARY BETH TANG PHONE NO : 714-961-3777 200 SOUTH KRAEMER BLVD.,W-104 SE DECISION MADE: 15-FEB-02 BREA, CA 92822-8000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD VACUTAINER SAFETY COAGULATION TUBE BECTON DICKINSON & CO. 510(k) NO: K013971(TRADITIONAL) ATTN: KEITH SMITH PHONE NO : 201-847-5837 1 BECTON DRIVE SE DECISION MADE: 01-FEB-02 FRANKLIN LAKES, NJ 07417-1885 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BERCHTOLD ELEKTROTOM 106 HITT BERCHTOLD CORP. 510(k) NO: K013668(TRADITIONAL) ATTN: MARIKA ANDERSON PHONE NO : 626-398-8934 590 CROSBY ST. SE DECISION MADE: 04-FEB-02 ALTADENA, CA 91001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88) BIOGENEX LABORATORIES 510(k) NO: K013148(TRADITIONAL) ATTN: GURVINDER S NANDA PHONE NO : 925-543-1336 4600 NORRIS CANYON RD. SE DECISION MADE: 28-FEB-02 SAN RAMON, CA 94583 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WATERLASE MILLENNIUM BIOLASE TECHNOLOGY, INC. 510(k) NO: K013908(TRADITIONAL) ATTN: IOANA M RIZOIU PHONE NO : 949-361-1200 981 CALLE AMANECER SE DECISION MADE: 12-FEB-02 SAN CLEMENTE, CA 92673 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TITANIUM RETROGRADE FEMORAL NAIL - 13 MM DIAMETER BIOMET ORTHOPEDICS, , INC. 510(k) NO: K013923(TRADITIONAL) ATTN: LONNIE WITHAM PHONE NO : 219-267-6639 P.O. BOX 587 SE DECISION MADE: 25-FEB-02 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPICCI II UNICONDYLAR KNEE SYSTEM BIOMET ORTHOPEDICS, , INC. 510(k) NO: K020264(SPECIAL) ATTN: DALENE T BINKLEY PHONE NO : 219-267-6639 P.O. BOX 587 SE DECISION MADE: 08-FEB-02 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOSORBFX O/M 2.0/2/4 SYSTEM BIONX IMPLANTS, INC. 510(k) NO: K011569(TRADITIONAL) ATTN: TUIJA ANNALA PHONE NO : 358 331 65679 HERMIANKATU 6-8 L SE DECISION MADE: 22-FEB-02 TAMPERE, FINLAND FIN-33720 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION OF THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM BIOPLATE, INC. 510(k) NO: K020088(SPECIAL) ATTN: CAROL E JONES PHONE NO : 323-549-9500 6911 MELROSE AVE. SE DECISION MADE: 08-FEB-02 LOS ANGELES, CA 90038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLOWGUARD DEVICE BIOSONIX LTD. 510(k) NO: K013803(TRADITIONAL) ATTN: AHAVA STEIN PHONE NO : 972 9 7670002 BEIT HAPA'AMON (BOX 124) SE DECISION MADE: 13-FEB-02 20 HATA'AS ST. 510(k) SUMMARY AVAILABLE FROM FDA KFAR SABA, ISRAEL 44425 DEVICE: E-SCAN XQ BIOSOUND ESAOTE, INC. 510(k) NO: K020164(SPECIAL) ATTN: COLLEEN DENSMORE PHONE NO : 317-849-1793 8000 CASTLEWAY DR. SE DECISION MADE: 12-FEB-02 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLACKSTONE SPINAL FIXATION SYSTEM POSTERIOR HOOKS BLACKSTONE MEDICAL, INC. 510(k) NO: K013885(TRADITIONAL) ATTN: ALAN LOMBARDO PHONE NO : 973-633-9968 90 BROOKSDALE DR. SE DECISION MADE: 01-FEB-02 SPRINGFIELD, MA 01104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS BOB J. JOHNSON & ASSOC., INC 510(k) NO: K014169(TRADITIONAL) ATTN: ROBERT SNYDER PHONE NO : 210-684-7638 7715 MAINLAND DR. # 115 SE DECISION MADE: 06-FEB-02 SAN ANTONIO,, TX 78250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTOVAC ORTHOPEDIC AUTOTRANSFUSION SYSTEM BOEHRINGER LABORATORIES 510(k) NO: K014187(TRADITIONAL) ATTN: JOHN KARPOWICZ PHONE NO : 610-278-0900 500 E. WASHINGTON STREET SE DECISION MADE: 06-FEB-02 NORRISTOWN, PA 19401 510(k) STATEMENT DEVICE: BACK-UP MEIER STEERABLE GUIDEWIRE BOSTON SCIENTIFIC CORP. 510(k) NO: K020283(TRADITIONAL) ATTN: JENNIFER BOLTON PHONE NO : 508-652-5972 ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 11-FEB-02 NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BRENTWOOD REAL TIME ST AND ARRHYTHMIA ANALYSIS SOFTWARE LIBRARY BRENTWOOD MEDICAL TECHNOLOGY CORP.510(k) NO: K013717(TRADITIONAL) ATTN: RUOMEI ZHANG PHONE NO : 310-530-5955 3300 FUJITA STREET SE DECISION MADE: 06-FEB-02 TORRANCE, CA 90505 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CANDELA SCLERO LONG PULSE LASER (AKA VBEAM) CANDELA CORP. 510(k) NO: K013748(TRADITIONAL) ATTN: L NELSON PHONE NO : 508-358-7637 530 BOSTON POST ROAD SE DECISION MADE: 11-FEB-02 WAYLAND, MA 01778 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CANDELA SMOOTHBEAM LASER SYSTEM CANDELA CORP. 510(k) NO: K013825(TRADITIONAL) ATTN: LORRAINE NELSON PHONE NO : 508-358-7637 530 BOSTON POST RD. SE DECISION MADE: 15-FEB-02 WAYLAND, MA 01778 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TM2000, MODEL 1 CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K013879(TRADITIONAL) ATTN: ALEX GONOROVSKY PHONE NO : 972 8 9484600 2 PEKERIS STREET SE DECISION MADE: 01-FEB-02 REHOVOT, ISRAEL 76100 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODE CARDIONET, INC 510(k) NO: K012241(TRADITIONAL) ATTN: DONALD V CANAL PHONE NO : 619-243-7500 510 MARKET STREET SE DECISION MADE: 01-FEB-02 SAN DIEGO, CA 92101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE CARDIOPULMONARY CORP. 510(k) NO: K020018(TRADITIONAL) ATTN: JOHN LAVIOLA PHONE NO : 203-301-6212 200 CASCADE BLVD. SE DECISION MADE: 21-FEB-02 MILFORD, CT 06460 510(k) STATEMENT DEVICE: CARESIDE APTT CARESIDE HEMOTOLOGY, INC. 510(k) NO: K014028(TRADITIONAL) ATTN: KENNETH B ASARCH PHONE NO : 310-338-6767 6100 BRISTOL PARKWAY SE DECISION MADE: 08-FEB-02 CULVER CITY, CA 90230 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAVITAT ULTRASOUND BONE DENSITOMETER ("CAVITAT") CAVITAT MEDICAL TECHNOLOGIES, INC.510(k) NO: K011147(TRADITIONAL) ATTN: LARRY R PILOT PHONE NO : 202-496-7500 1900 K STREET, N.W. SE DECISION MADE: 15-FEB-02 WASHINGTON, DC 20006-1108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHASE CARDIOVASCULAR PATCH KIT CHASE MEDICAL, INC. 510(k) NO: K020132(TRADITIONAL) ATTN: DAVE HERNON PHONE NO : 972-783-0644 1710 FIRMAN DRIVE SE DECISION MADE: 26-FEB-02 SUITE 100 510(k) STATEMENT RICHARDSON, TX 75081 DEVICE: EXCELSIOR TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. CHAY MEDICAL, LLC. 510(k) NO: K013342(TRADITIONAL) ATTN: STEPHEN C PEARSON PHONE NO : 707-481-3204 3257 ROUTE 128 SE DECISION MADE: 15-FEB-02 CALISTOGA, CA 94515 510(k) STATEMENT DEVICE: OCULAR SCIENCES, INC. BIOMEDICS UV ASPHERE (OCUFILCON D) SOFT (H CL MCINTOSH 510(k) NO: K020193(ABBREVIATED) ATTN: RICHARD E LIPPMAN PHONE NO : 301-770-9590 12300 TWINBROOK PKWY. STE. 230 SE DECISION MADE: 28-FEB-02 ROCKVILLE, MD 20852 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEARMEDICAL/AIRCAST VENAFLOW CALF CUFF, CLEARMEDICAL AIRCAST XL CLEAR MEDICAL, INC. 510(k) NO: K012601(TRADITIONAL) ATTN: RICHARD RADFORD PHONE NO : 425-401-1414 1776 136TH PL. NE SE DECISION MADE: 06-FEB-02 BELLEVUE, WA 98005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEARMEDICAL/KENDALL KNEE-HIGH SCD SLEEVES, CLEARMEDICAL/KENDALL CLEAR MEDICAL, INC. 510(k) NO: K012606(TRADITIONAL) ATTN: RICHARD RADFORD PHONE NO : 425-401-1414 1776 136TH PL. NE SE DECISION MADE: 06-FEB-02 BELLEVUE, WA 98005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEARMEDICAL/NOVAMEDIX AVI FOOT COVER, PAIR, REGULAR & LARGE SIZ CLEAR MEDICAL, INC. 510(k) NO: K012612(TRADITIONAL) ATTN: RICHARD RADFORD PHONE NO : 425-401-1414 1776 136TH PL. NE SE DECISION MADE: 06-FEB-02 BELLEVUE, WA 98005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEARMEDICAL/HUNTLEIGH FOOT GARMENTS; MODELS FG200/LRG (LARGE), CLEAR MEDICAL, INC. 510(k) NO: K012616(TRADITIONAL) ATTN: RICHARD RADFORD PHONE NO : 425-401-1414 1776 136TH PL. NE SE DECISION MADE: 06-FEB-02 BELLEVUE, WA 98005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEARMEDICAL/HENTLEIGH DEEP VEIN THROMBOSIS (DVT) GARMENT CLEAR MEDICAL, INC. 510(k) NO: K012621(TRADITIONAL) ATTN: RICHARD RADFORD PHONE NO : 425-401-1414 1776 136TH PL. NE SE DECISION MADE: 06-FEB-02 BELLEVUE, WA 98005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRYSTAL MONITOR MODEL 16 CLEVELAND MEDICAL DEVICES, INC. 510(k) NO: K013863(TRADITIONAL) ATTN: ROBERT N SCHMIDT PHONE NO : 216-791-6720 11000 CEDAR AVE., SUITE 130 SE DECISION MADE: 19-FEB-02 CLEVELAND, OH 44106 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLINICON UNIVERSAL WAVEGUIDE HANDPIECE AND FIBER TIPS CLINICON CORP. 510(k) NO: K014048(TRADITIONAL) ATTN: SEAN M CURRY PHONE NO : 858-675-8200 16787 BERNARDO CENTER DRIVE SE DECISION MADE: 11-FEB-02 SUITE A 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92128 DEVICE: TASK FORCE MONITOR 3040 CNSYSTEMS MEDIZINTECHNIK GMBH 510(k) NO: K014063(TRADITIONAL) ATTN: CHRISTIAN WAGNER PHONE NO : 43 316 7234560 BAUMKIRCHERSTRASSE 1 SE DECISION MADE: 07-FEB-02 A-8020 GRAZ 510(k) SUMMARY AVAILABLE FROM FDA EUROPE, AUSTRIA THIRD PARTY REVIEW DEVICE: COBE REVOLUTION COBE CARDIOVASCULAR, INC. 510(k) NO: K011835(ABBREVIATED) ATTN: LYNNE LEONARD PHONE NO : 303-467-6586 14401 WEST 65TH WAY SE DECISION MADE: 12-FEB-02 ARVADA, CO 80004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIODENT DENTAL LASER SYSTEM CONTINUUM ELECTRO-OPTICS, INC. 510(k) NO: K013216(TRADITIONAL) ATTN: RONALD KOHLHARDT PHONE NO : 408-727-3240 3150 CENTRAL EXPRESSWAY SE DECISION MADE: 27-FEB-02 SANTA CLARA, CA 95051 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC PIPETTES (BIOPSY PIPETTE COOK UROLOGICAL, INC. 510(k) NO: K014160(TRADITIONAL) ATTN: DEBBIE SCHMITT PHONE NO : 812-829-6500 1100 WEST MORGAN ST. SE DECISION MADE: 08-FEB-02 P.O. BOX 227 510(k) SUMMARY AVAILABLE FROM FDA SPENCER, IN 47460 DEVICE: ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET COOK, INC. 510(k) NO: K013241(TRADITIONAL) ATTN: HEIDI MASTEN PHONE NO : 812-339-2235 925 SOUTH CURRY PIKE SE DECISION MADE: 21-FEB-02 P.O. BOX 489 510(k) SUMMARY AVAILABLE FROM FDA BLOOMINGTON, IN 47402 DEVICE: PATIL EMERGENCY CRICOTHYROTOMY CATHETER SET COOK, INC. 510(k) NO: K013252(TRADITIONAL) ATTN: HEIDI MASTEN PHONE NO : 812-339-2235 925 SOUTH CURRY PIKE SE DECISION MADE: 21-FEB-02 P.O. BOX 489 510(k) SUMMARY AVAILABLE FROM FDA BLOOMINGTON, IN 47402 DEVICE: SMART NITINOL STENT TRANSHEPATIC BILIARY SYSTEM CORDIS CORP. 510(k) NO: K020052(SPECIAL) ATTN: SAM MIRZA PHONE NO : 305-824-2007 14201 N.W. 60TH AVE. SE DECISION MADE: 11-FEB-02 MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GINDA GUARD COSMEDENT, INC. 510(k) NO: K011239(TRADITIONAL) ATTN: MICHAEL O'MALLEY PHONE NO : 312-644-9586 401 N. MICHIGAN AVE. SE DECISION MADE: 14-FEB-02 SUITE 2500 510(k) STATEMENT CHICAGO, IL 60611 DEVICE: CP-SLEEVE CP MEDICAL 510(k) NO: K013975(TRADITIONAL) ATTN: MARY ANN GREENWALT PHONE NO : 503-232-1555 836 N.E. 24TH AVE. SE DECISION MADE: 22-FEB-02 PORTLAND, OR 97232 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMARTEPIL CYNOSURE, INC. 510(k) NO: K020107(SPECIAL) ATTN: GEORGE CHO PHONE NO : 978-256-4200 10 ELIZABETH DR. SE DECISION MADE: 07-FEB-02 CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH TETRA DADE BEHRING, , INC. 510(k) NO: K020173(TRADITIONAL) ATTN: MAUREEN MENDE PHONE NO : 916-374-3174 2040 ENTERPRISE BLVD. SE DECISION MADE: 06-FEB-02 WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC COMBO PANELS WITH GENTA DADE BEHRING, , INC. 510(k) NO: K020185(TRADITIONAL) ATTN: MAUREEN MENDE PHONE NO : 916-372-1900 2040 ENTERPRISE BLVD. SE DECISION MADE: 06-FEB-02 WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH TOBRAMYCIN DADE BEHRING, INC. 510(k) NO: K020168(TRADITIONAL) ATTN: MAUREEN MENDE PHONE NO : 916-374-3174 2040 ENTERPRISE BOULEVARD SE DECISION MADE: 06-FEB-02 WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH NETIL DADE BEHRING, INC. 510(k) NO: K020182(TRADITIONAL) ATTN: MAUREEN MENDE PHONE NO : 916-372-1900 2040 ENTERPRISE BOULEVARD SE DECISION MADE: 06-FEB-02 WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH AMIKA DADE BEHRING, INC. 510(k) NO: K020209(TRADITIONAL) ATTN: MAUREEN MENDE PHONE NO : 916-374-3174 2040 ENTERPRISE BOULEVARD SE DECISION MADE: 06-FEB-02 WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH IMIPE DADE BEHRING, INC. 510(k) NO: K020246(TRADITIONAL) ATTN: MAUREEN MENDE PHONE NO : 916-374-3174 1584 ENTERPRISE BOULEVARD SE DECISION MADE: 06-FEB-02 WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH MEROP DADE BEHRING, INC. 510(k) NO: K020249(TRADITIONAL) ATTN: MAUREEN MENDE PHONE NO : 916-374-3174 1584 ENTERPRISE BOULEVARD SE DECISION MADE: 06-FEB-02 WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEFUR DADE BEHRING, INC. 510(k) NO: K020328(TRADITIONAL) ATTN: MAUREEN MENDE PHONE NO : 916-374-3174 1584 ENTERPRISE BOULEVARD SE DECISION MADE: 19-FEB-02 WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PG DAKO CORP. 510(k) NO: K020023(TRADITIONAL) ATTN: GRETCHEN M MURRAY PHONE NO : 805-566-6655 6392 VIA REAL SE DECISION MADE: 28-FEB-02 CARPINTERIA, CA 93013 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIEWPOINT CENTRAL MONITORING SYSTEM, MODEL 0998-00-0187-07 DATASCOPE CORP. 510(k) NO: K011540(ABBREVIATED) ATTN: SUSAN E MANDY PHONE NO : 201-995-8391 800 MACARTHUR BLVD. SE DECISION MADE: 06-FEB-02 MAHWAK, NJ 07430-0619 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JETPOLISHER DELDENT LTD. 510(k) NO: K014249(TRADITIONAL) ATTN: ALAN EDEL PHONE NO : 972 3 9049668 19 KEREN KAYEMET STREET SE DECISION MADE: 19-FEB-02 PETACH TIKVAH, ISRAEL 49372 510(k) STATEMENT DEVICE: JETSTREAM DELDENT LTD. 510(k) NO: K014252(TRADITIONAL) ATTN: ALAN EDEL PHONE NO : 972 3 9049668 19 KEREN KAYEMET STREET SE DECISION MADE: 19-FEB-02 PETACH TIKVAH, ISRAEL 49372 510(k) STATEMENT DEVICE: DEPILASE TWIN LASE LASER SYSTEM DEPILASE GROUP LTD. 510(k) NO: K020412(TRADITIONAL) ATTN: MARIO RUSSO PHONE NO : 442 077 121675 ONE CANADA SQUARE SE DECISION MADE: 22-FEB-02 LONDON, UNITED KINGDOM E14 5DY 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: DEPILASE YAG LASE PLUS LASER SYSTEM DEPILASE GROUP LTD. 510(k) NO: K020463(TRADITIONAL) ATTN: MARIO LUCA RUSSO PHONE NO : 44 20 77121675 ONE CANADA SQUARE SE DECISION MADE: 27-FEB-02 LONDON, UNITED KINGDOM E14 5DY 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: BONART ART-E1 ELECTROSURGERY UNIT DIAGNOSTIC DATA, INC. 510(k) NO: K020080(TRADITIONAL) ATTN: ROBERT E JOHNSON PHONE NO : 909-946-0099 1342-D NORTH BENSON AVENUE SE DECISION MADE: 19-FEB-02 UPLAND, CA 91786 510(k) STATEMENT DEVICE: TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA) DIAGNOSTICS BIOCHEM CANADA, INC. 510(k) NO: K014120(TRADITIONAL) ATTN: G. R. DUMONT PHONE NO : 519 681 8731 1020 HARGRIEVE RD. SE DECISION MADE: 08-FEB-02 LONDON, ONTARIO, CANADA N6E 1P5 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR DIDECO S.P.A. 510(k) NO: K020351(SPECIAL) ATTN: BARRY SALL PHONE NO : 781-434-4742 195 WEST STREET SE DECISION MADE: 26-FEB-02 WALTHAM, MA 02451-1163 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DRG REACTION CHAMBER/SAFETY TIP DOCTOR'S RESEARCH GROUP, INC. 510(k) NO: K012003(TRADITIONAL) ATTN: RICHARD DESLAURIERS PHONE NO : 203-879-9422 143 WOLCOTT RD. SE DECISION MADE: 12-FEB-02 WOLCOTT, CT 06716 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER DOLPHIN MEDICAL INC. 510(k) NO: K020075(SPECIAL) ATTN: JON WERNER PHONE NO : 813-818-7488 13801 MCCORMICK DRIVE SE DECISION MADE: 08-FEB-02 TAMPA, FL 33626 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GS DRAEGER MEDICAL, INC. 510(k) NO: K011404(TRADITIONAL) ATTN: MICHAIL A KELHART PHONE NO : 215-721-5400 3135 QUARRY RD. SE DECISION MADE: 22-FEB-02 TELFORD, PA 18969 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WIN-2 TANGO ELITE NP DURABLE MEDICAL EQUIPMENT, INC. 510(k) NO: K013361(TRADITIONAL) ATTN: ROBERT S MCQUATE PHONE NO : 602-788-5651 3636 E. COLUMBINE DR. SE DECISION MADE: 26-FEB-02 PHOENIX, AZ 85032-7372 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROTOCO2L INSUFFLATOR MODEL 6400 E-Z-EM, INC. 510(k) NO: K013219(ABBREVIATED) ATTN: ROBERT WILLIAMS PHONE NO : 516-333-8433 717 MAIN ST. SE DECISION MADE: 19-FEB-02 WESTBURY, NY 11590 510(k) STATEMENT DEVICE: MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM EBI, L.P. 510(k) NO: K020141(SPECIAL) ATTN: PATRICIA M FLOOD PHONE NO : 973-299-9300 100 INTERPACE PKWY. SE DECISION MADE: 05-FEB-02 PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFESTITCH SUTURING DEVICE EDWARDS LIFESCIENCES, LLC. 510(k) NO: K013990(TRADITIONAL) ATTN: LUCINDA STOCKERT PHONE NO : 949-250-2438 ONE EDWARDS WAY SE DECISION MADE: 27-FEB-02 IRVINE, CA 92614-5686 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BREATHING CIRCUIT FILTER EMERGENCY FILTRATION PRODUCTS, INC510(k) NO: K012958(TRADITIONAL) ATTN: DOUGLAS K BEPLATE PHONE NO : 702-798-4541 4335 SOUTH INDUSTRIAL RD.,#440 SE DECISION MADE: 22-FEB-02 LAS VEGAS, NV 89103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP ENCORE ORTHOPEDICS, INC. 510(k) NO: K020170(SPECIAL) ATTN: JOANNA DROEGE PHONE NO : 512-832-9500 9800 METRIC BLVD. SE DECISION MADE: 11-FEB-02 AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO PASS SPINAL SYSTEM ENCORE ORTHOPEDICS, INC. 510(k) NO: K020236(SPECIAL) ATTN: JOANNA DROEGE PHONE NO : 512-832-9500 9800 METRIC BLVD. SE DECISION MADE: 14-FEB-02 AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDIUS CERVICAL PLATE SYSTEM ENDIUS, INC. 510(k) NO: K014107(TRADITIONAL) ATTN: GENE DIPOTO PHONE NO : 508-643-0983 23 WEST BACON ST. SE DECISION MADE: 13-FEB-02 PLAINVILLE, MA 02762 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDIAL ROTATION KNEE SYSTEM ENGINEERING CONSULTING SERVICES, I510(k) NO: K020214(TRADITIONAL) ATTN: AL LIPPINCOTT PHONE NO : 952-492-5858 3150 E. 200TH ST. SE DECISION MADE: 26-FEB-02 PRIOR LAKE, MN 55372 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOANCHOR AND OPENANCHOR ETHICON ENDO-SURGERY, INC. 510(k) NO: K013749(TRADITIONAL) ATTN: DOUG KENTZ PHONE NO : 513-337-8699 4545 CREEK RD. SE DECISION MADE: 11-FEB-02 CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFECARE 5*5 CM SQUARE, LIFECARE 4*4 CM SQUARE, LIFECARE 5 CM RO EVERYWAY MEDICAL INSTRUMENTS CO., 510(k) NO: K012463(TRADITIONAL) ATTN: ROBERT TU PHONE NO : 886 226 620038 3 FL.NO.5 LN.155 BEI-SHEND RD. SE DECISION MADE: 05-FEB-02 SEC. 3 510(k) STATEMENT SHEN KENG HSIANG,TAIPEI HSIEN, CHINA (TAIWAN) 222 DEVICE: EXACTECH, MODEL PMMA FEMORAL STEM CENTRALIZER EXACTECH, INC. 510(k) NO: K020291(SPECIAL) ATTN: ROBERT PAXTON PHONE NO : 352-377-1140 2320 N.W. 66TH CT. SE DECISION MADE: 27-FEB-02 GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PACIFIC HEMOSTASIS REFERENCE EMULSION FISHER DIAGNOSTICS 510(k) NO: K013397(TRADITIONAL) ATTN: JERALD P STEINER PHONE NO : 540-869-3200 8365 VALLEY PIKE SE DECISION MADE: 15-FEB-02 P.O. BOX 307 510(k) STATEMENT MIDDLETOWN, VA 22645-3200 DEVICE: SMARTFLOW PULSE TRANSMISSION COEFFICIENT FLORENCE MEDICAL LTD. 510(k) NO: K020127(SPECIAL) ATTN: ORLY MAOR PHONE NO : 972 977 18130 117 AHUZAH STREET SE DECISION MADE: 14-FEB-02 RA'ANANNA, ISRAEL 43373 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE AND YELLOWISH WH FORMOSA GLOVE INDUSTRIAL CO., LTD.510(k) NO: K014284(TRADITIONAL) ATTN: TIANG S CHANG PHONE NO : 908-233-3571 1016 SEWARD AVE. SE DECISION MADE: 15-FEB-02 WESTFIELD, NJ 07090 510(k) STATEMENT DEVICE: NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE, PURPLE FORMOSA GLOVE INDUSTRIAL CO., LTD.510(k) NO: K014285(TRADITIONAL) ATTN: TIANG S CHANG PHONE NO : 908-233-3571 1016 SEWARD AVE. SE DECISION MADE: 14-FEB-02 WESTFIELD, NJ 07090 510(k) STATEMENT DEVICE: FUKUDA DENSHI DYNASCOPE MODEL DS-5700 FUKUDA DENSHI USA, INC. 510(k) NO: K020084(SPECIAL) ATTN: LARRY D WALKER PHONE NO : 800-365-6668 17725 N.E. 65TH ST., BLDG. C SE DECISION MADE: 06-FEB-02 REDMOND, WA 98052-4911 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNIFIL BOND GC AMERICA, INC. 510(k) NO: K013997(TRADITIONAL) ATTN: TERRY L JORITZ PHONE NO : 708-926-3105 3737 WEST 127TH ST. SE DECISION MADE: 20-FEB-02 ALSIP, IL 60803 510(k) STATEMENT DEVICE: GC FUJI LINING LC PASTE PAK GC AMERICA, INC. 510(k) NO: K020117(TRADITIONAL) ATTN: TERRY L JORITZ PHONE NO : 708-926-3105 3737 WEST 127TH ST. SE DECISION MADE: 28-FEB-02 ALSIP, IL 60803 510(k) STATEMENT DEVICE: STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SIT GDS TECHNOLOGY 510(k) NO: K020138(SPECIAL) ATTN: RICHARD TYHACH PHONE NO : 219-264-7384 25235 LEER DR. SE DECISION MADE: 11-FEB-02 ELKHART, IN 46514 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVANTAGE WORKSTATION 4.1 GE MEDICAL SYSTEMS 510(k) NO: K020483(TRADITIONAL) ATTN: SCOTT R EVANS PHONE NO : 847-704-8878 800 BUSINESS CENTER DR. SE DECISION MADE: 28-FEB-02 MOUNT PROSPECT, IL 60056 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: DINAMAP PRO SERIES MONITOR, MODELS 110, 210, 310, 410 GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K020022(SPECIAL) ATTN: THOMAS ENGLISH PHONE NO : 817-887-2107 4502 WOODLAND CORP.BLVD. SE DECISION MADE: 01-FEB-02 TAMPA, FL 33614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LOGIQ 3 GENERAL ELECTRIC CO. 510(k) NO: K020263(SPECIAL) ATTN: ALLEN SCHUH PHONE NO : 414-647-4385 P.O. BOX 414 SE DECISION MADE: 06-FEB-02 MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOLAR 8000M SYSTEM GENERAL ELECTRIC MEDICAL SYSTEMS I510(k) NO: K012467(TRADITIONAL) ATTN: KAREN WEBB PHONE NO : 414-362-3329 8200 WEST TOWER AVE. SE DECISION MADE: 11-FEB-02 MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENTLE COLONICS IRRIGATION SYSTEM GENTLE COLONICS, INC. 510(k) NO: K002102(TRADITIONAL) ATTN: GRACE HOLLAND PHONE NO : 949-262-0411 3722 AVENUE SAUSALITO SE DECISION MADE: 06-FEB-02 IRVINE, CA 92606-1849 510(k) STATEMENT DEVICE: SOFTIQUE, MODEL GI 11001 GLOBAL TV CONCEPTS, LTD. 510(k) NO: K013707(TRADITIONAL) ATTN: LAURIE BRADEN PHONE NO : 954-570-9999 676 SOUTH MILITARY TRAIL SE DECISION MADE: 01-FEB-02 DEERFIELD BEACH, FL 33442 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TWIN PLUS GRASS-TELEFACTOR DIVISON 510(k) NO: K012976(TRADITIONAL) ATTN: JOHN B CHATTEN PHONE NO : 401-828-4000 SE DECISION MADE: 12-FEB-02 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VACUETTE EDTA K2 TUBES GREINER VACUETTE NORTH AMERICA, IN510(k) NO: K014104(TRADITIONAL) ATTN: JUDI SMITH PHONE NO : 410-592-2060 P.O. BOX 103 SE DECISION MADE: 01-FEB-02 BALDWIN, MD 21013 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VASOVIEW 5 HARVESTING CANNULA GUIDANT CARDIAC SURGERY 510(k) NO: K020143(TRADITIONAL) ATTN: ANNE SCHLAGENHAFT PHONE NO : 408-845-1842 3200 LAKESIDE DR. SE DECISION MADE: 20-FEB-02 SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: AGILTRAC .018 PERIPHERAL DILATATION CATHETER GUIDANT CORP. 510(k) NO: K020161(SPECIAL) ATTN: CURTIS TRUESDALE PHONE NO : 408-845-1419 3200 LAKESIDE DR. SE DECISION MADE: 22-FEB-02 SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRAPSYSTEM SET H.S. HOSPITAL SERVICE S.R.L. 510(k) NO: K013692(TRADITIONAL) ATTN: LUCIO IMPROTA PHONE NO : 561-477-1671 10147 UMBERLAND PLACE SE DECISION MADE: 05-FEB-02 BOCA RATON, FL 33428 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVANCED AIR PURIFICATION SYSTEM; HEPA AIR CLEANING SYSTEM HEALTHWAY PRODUCTS, INC. 510(k) NO: K012549(TRADITIONAL) ATTN: DICK BRIGGS PHONE NO : 315-463-0240 PO BOX 2729 SE DECISION MADE: 04-FEB-02 SYRACUSE, NY 13220-2729 510(k) STATEMENT DEVICE: HENKE SASS WOLF SAPHENOUS VEIN LAPAROSCOPE HENKE SASS WOLF OF AMERICA, INC. 510(k) NO: K013611(TRADITIONAL) ATTN: LYNETTE HOWARD PHONE NO : 908-788-4580 203 MAIN STREET, PMB 166 SE DECISION MADE: 01-FEB-02 FLEMINGTON, NJ 08822 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENRAF-NONIUS ENDOMED 182 SYSTEM HENLEY HEALTHCARE, INC. 510(k) NO: K003744(TRADITIONAL) ATTN: REBECCA STOUT PHONE NO : 281-276-7000 120 INDUSTRIAL BLVD. SE DECISION MADE: 20-FEB-02 SUGAR LAND, TX 77478 510(k) STATEMENT DEVICE: VENUS UNIVERSAL LIGHT CURING COMPOSITE HERAEUS KULZER, INC. 510(k) NO: K020131(TRADITIONAL) ATTN: CHERYL V ZIMMERMAN PHONE NO : 219-291-0661 4315 SOUTH LAFAYETTE BLVD. SE DECISION MADE: 28-FEB-02 SOUTH BEND, IN 46614-2517 510(k) STATEMENT DEVICE: MODIFICATION TO: EUB-8500 DIAGNOSTIC ULTRASOUND SCANNER HITACHI MEDICAL CORP. 510(k) NO: K013722(SPECIAL) ATTN: WALTER WEYBURNE PHONE NO : 914-524-9711 660 WHITE PLAINS ROAD SE DECISION MADE: 11-FEB-02 TARRYTOWN, NY 10591-5107 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER HITACHI MEDICAL CORP. 510(k) NO: K013723(SPECIAL) ATTN: WALTER WEYBURNE PHONE NO : 914-524-9711 660 WHITE PLAINS ROAD SE DECISION MADE: 06-FEB-02 TARRYTOWN, NY 10591-5107 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTEONICS SPINAL SYSTEM HOWMEDICA OSTEONICS CORP. 510(k) NO: K020293(SPECIAL) ATTN: KAREN ARIEMMA PHONE NO : 201-760-8187 59 ROUTE 17 SE DECISION MADE: 14-FEB-02 ALLENDALE, NJ 07070-2584 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-M HUMAGEN FERTILITY DIAGNOSTICS, INC510(k) NO: K012811(TRADITIONAL) ATTN: CINDY SHOWALTER PHONE NO : 434-979-4000 2400 HUNTER'S WAY SE DECISION MADE: 11-FEB-02 CHARLOTTESVILLE, VA 22911 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM HYPOGUARD USA, INC. 510(k) NO: K020232(TRADITIONAL) ATTN: BRUCE A MACFARLANE PHONE NO : 952-646-3188 5182 WEST 76TH ST. SE DECISION MADE: 12-FEB-02 EDINA, MN 55439 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PARAGON INFUSION SYSTEM I-FLOW CORP. 510(k) NO: K020251(SPECIAL) ATTN: SHANE NOEHRE PHONE NO : 949-206-2700 20202 WINDROW DR. SE DECISION MADE: 15-FEB-02 LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONCERT RADIOPAQUE BONE CEMENT IMMEDICA, INC. 510(k) NO: K013755(TRADITIONAL) ATTN: RUSSELL PAGANO PHONE NO : 202-546-1262 615 7TH STREET NE SE DECISION MADE: 08-FEB-02 WASHINGTON, DC 20002 510(k) STATEMENT DEVICE: GELZONE IMPLANTECH ASSOCIATES, INC. 510(k) NO: K013732(TRADITIONAL) ATTN: STEPHEN MEADE PHONE NO : 805-339-9415 2064 EASTMAN AVE., UNIT 101 SE DECISION MADE: 07-FEB-02 VENTURA, CA 93003 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEXGEN LPS TRABECULAR METAL MONOBLOCK TIBIA; ZIMMER CAT # 00-588 IMPLEX CORP. 510(k) NO: K020295(SPECIAL) ATTN: LES HEIMANN PHONE NO : 201-818-1800 80 COMMERCE DR. SE DECISION MADE: 12-FEB-02 ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORION DIGITAL IMAGING SYSTEM INFIMED, INC. 510(k) NO: K012490(TRADITIONAL) ATTN: RALPH J FLATAU PHONE NO : 315-453-4545 121 METROPOLITAN DR. SE DECISION MADE: 12-FEB-02 LIVERPOOL, NY 13088 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INION CPS BSSO SCREW INION LTD. 510(k) NO: K020266(SPECIAL) ATTN: HANNA MARTTILA PHONE NO : 358 3 2306600 LAAKARINKATU 2 SE DECISION MADE: 22-FEB-02 TAMPERE, FINLAND FIN-33520 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOSCOPIC MULTI-FIRE CLIP APPLIER INSCOPE, LLC. 510(k) NO: K013889(TRADITIONAL) ATTN: BRUCE WEBER PHONE NO : 305-716-7000 8210 NW 27TH ST. SE DECISION MADE: 07-FEB-02 MIAMI, FL 33122 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNOCTA ANGLED ABUTMENTS FOR THE ITI WIDE NECK IMPLANT INSTITUT STRAUMANN AG 510(k) NO: K013891(SPECIAL) ATTN: LINDA JALBERT PHONE NO : 800-448-8168 RESERVOIR PLACE SE DECISION MADE: 05-FEB-02 1601 TRAPELO ROAD 510(k) SUMMARY AVAILABLE FROM FDA WALTHAM, MA 02451 DEVICE: ESTHETIC EASE ABUTMENTS FOR THE ITI DENTAL IMPLANT SYSTEM INSTITUT STRAUMANN AG 510(k) NO: K020096(SPECIAL) ATTN: LINDA JALBERT PHONE NO : 800-448-8168 RESERVOIR PLACE SE DECISION MADE: 08-FEB-02 1601 TRAPELO ROAD 510(k) SUMMARY AVAILABLE FROM FDA WALTHAM, MA 02451 DEVICE: MEDSURG EQUIPMENT COVERS INTERNATIONAL MEDSURG CONNECTION 510(k) NO: K014239(TRADITIONAL) ATTN: MICHELE H VOVOLKA PHONE NO : 847-856-0355 P.O. BOX 848 SE DECISION MADE: 19-FEB-02 GRAYSLAKE, IL 60030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO GEO STRUCTURE INTERPORE CROSS INTL. 510(k) NO: K020048(SPECIAL) ATTN: LYNN M RODARTI PHONE NO : 949-453-3200 181 TECHNOLOGY DR. SE DECISION MADE: 06-FEB-02 IRVINE, CA 92618-2402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM, MO INTERPORE CROSS INTL. 510(k) NO: K020204(SPECIAL) ATTN: LYNN M RODARTI PHONE NO : 949-453-3200 181 TECHNOLOGY DR. SE DECISION MADE: 21-FEB-02 IRVINE, CA 92618-2402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTERGARD HEMABRIDGE COLLAGEN COATED VASCULAR PROSTHESIS, INTERG INTERVASCULAR 510(k) NO: K013651(TRADITIONAL) ATTN: AMY AULWES PHONE NO : 781-431-7240 20 WALNUT ST.; SUITE 12 SE DECISION MADE: 27-FEB-02 WELLESLEY, MA 02481 510(k) STATEMENT DEVICE: PULSION FS LASER KERATOME INTRALASE CORP. 510(k) NO: K013941(TRADITIONAL) ATTN: JUDY F GORDON PHONE NO : 949-854-6314 2 DELPHINUS SE DECISION MADE: 27-FEB-02 IRVINE, CA 92612 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTUITIVE SURGICAL STERO VIEW ENDOSCOPIC SYSTEM INTUITIVE SURGICAL, INC. 510(k) NO: K013952(TRADITIONAL) ATTN: MICHAEL YRAMATEGUL PHONE NO : 650-237-7000 1340 WEST MIDDLEFIELD RD. SE DECISION MADE: 28-FEB-02 MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DR. HAYS BITE GUARD INVENTIVE RESOURCES, INC. 510(k) NO: K014079(TRADITIONAL) ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640 200 GREGORY LANE SE DECISION MADE: 22-FEB-02 SUITE C-100 510(k) SUMMARY AVAILABLE FROM FDA PLEASANT HILL, CA 94523-3389 DEVICE: CENTURION 2000 CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYS INVIVO RESEARCH, INC. 510(k) NO: K002604(TRADITIONAL) ATTN: FRANCIS X CASEY PHONE NO : 407-275-3220 12601 RESEARCH PKWY. SE DECISION MADE: 07-FEB-02 ORLANDO, FL 32826 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: D.SIGN 59 IVOCLAR VIVADENT, INC. 510(k) NO: K013809(TRADITIONAL) ATTN: ANDERJEET GULATI PHONE NO : 716-691-0010 175 PINEVIEW DR. SE DECISION MADE: 07-FEB-02 AMHERST, NY 14228 510(k) STATEMENT DEVICE: HELIOMOLAR HB TRANSLUCENT SHADES IVOCLAR VIVADENT, INC. 510(k) NO: K013929(TRADITIONAL) ATTN: DONNA M HARTNETT PHONE NO : 716-691-0010 175 PINEVIEW DR. SE DECISION MADE: 07-FEB-02 AMHERST, NY 14228 510(k) STATEMENT DEVICE: D.SIGN 84 IVOCLAR VIVADENT, INC. 510(k) NO: K014042(TRADITIONAL) ATTN: ANDERJEET S GULATI PHONE NO : 800-533-6825 175 PINEVIEW DR. SE DECISION MADE: 22-FEB-02 AMHERST, NY 14228 510(k) STATEMENT DEVICE: VERAVIEWEPOCS, MODEL VE J. MORITA USA, INC. 510(k) NO: K013955(TRADITIONAL) ATTN: WILLIAM D HARE PHONE NO : 202-783-5070 601 13TH STREET, N.W. SE DECISION MADE: 04-FEB-02 WASHINGTON, DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDIGROUP CATHETER EXTENDER/REPAIR KIT JANIN GROUP, INC. 510(k) NO: K012502(TRADITIONAL) ATTN: JOHN A NAVIS PHONE NO : 630-428-4143 505 WESTON RIDGE DR. SE DECISION MADE: 04-FEB-02 NAPERVILLE, IL 60563-3932 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JAS AMYLASE LIQUID REAGENT JAS DIAGNOSTIC, INC. 510(k) NO: K020282(TRADITIONAL) ATTN: DAVID JOHNSON PHONE NO : 305-418-2320 7220 NW 58TH ST. SE DECISION MADE: 28-FEB-02 MIAMI, FL 33166 510(k) STATEMENT DEVICE: DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1) JENERIC/PENTRON, INC. 510(k) NO: K013542(TRADITIONAL) ATTN: ANNMARIE TENERO PHONE NO : 203-265-7397 53 NORTH PLAINS INDUSTRIAL RD. SE DECISION MADE: 14-FEB-02 P.O. BOX 724 510(k) SUMMARY AVAILABLE FROM FDA WALLINGFORD, CT 06492-0724 DEVICE: BOND-1 C & B JENERIC/PENTRON, INC. 510(k) NO: K013543(TRADITIONAL) ATTN: ANNMARIE TENERO PHONE NO : 203-265-7397 53 NORTH PLAINS INDUSTRIAL RD. SE DECISION MADE: 22-FEB-02 P.O. BOX 724 510(k) SUMMARY AVAILABLE FROM FDA WALLINGFORD, CT 06492-0724 DEVICE: PROMOGRAN MATRIX WOUND DRESSING JOHNSON & JOHNSON MEDICAL, LTD. 510(k) NO: K014129(TRADITIONAL) ATTN: SERGIO J GADALETA PHONE NO : 908-218-2893 ROUTE 22 WEST SE DECISION MADE: 14-FEB-02 P.O. BOX 151 510(k) SUMMARY AVAILABLE FROM FDA SOMERVILLE, NJ 08876 DEVICE: JOSTRA DUAL STAGE VENOUS RETURN CANNULAE JOSTRA AG 510(k) NO: K013944(TRADITIONAL) ATTN: KATHLEEN JOHNSON PHONE NO : 610-932-7738 478 MEDIA ROAD SE DECISION MADE: 11-FEB-02 OXFORD, PA 19363 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET KAMIYA BIOMEDICAL CO. 510(k) NO: K014293(TRADITIONAL) ATTN: COLIN GETTY PHONE NO : 206-575-8068 910 INDUSTRY DR. SE DECISION MADE: 19-FEB-02 SEATTLE, WA 98188-3412 510(k) STATEMENT DEVICE: MODIFICATION TO DATACAPTOR KAMM & ASSOC. 510(k) NO: K020197(SPECIAL) ATTN: DANIEL KAMM PHONE NO : 847-374-1727 P.O. BOX 7007 SE DECISION MADE: 21-FEB-02 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDERFREE LATEX SURGEON'S GLOVES KANAM LATEX INDUSTRIES PVT. LTD. 510(k) NO: K013914(TRADITIONAL) ATTN: RAVI ABRAHAM PHONE NO : 914 815 63513 K.K. RD., OOPPOOTTIL BLDGS. SE DECISION MADE: 06-FEB-02 P.O. BOX 28 510(k) STATEMENT KOTTAYAM, KERALA, INDIA 686001 DEVICE: BIOABSORBABLE INTERFERENCE SCREW MEGAFIX KARL STORZ ENDOSCOPY 510(k) NO: K013107(TRADITIONAL) ATTN: JAMES A LEE PHONE NO : 310-410-2769 600 CORPORATE POINTE SE DECISION MADE: 26-FEB-02 CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEMETRON LC KERR CORP. 510(k) NO: K014179(TRADITIONAL) ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484 1717 WEST COLLINS AVE. SE DECISION MADE: 04-FEB-02 ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTIBOND SOLO PLUS 4 KERR DENTAL MATERIALS CENTER 510(k) NO: K014027(TRADITIONAL) ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484 1717 WEST COLLINS AVENUE SE DECISION MADE: 22-FEB-02 ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TEMPHASE KERR DENTAL MATERIALS CENTER 510(k) NO: K020092(TRADITIONAL) ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484 1717 WEST COLLINS AVENUE SE DECISION MADE: 22-FEB-02 ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO VIEWSEND MEDICAL KLT TELECOM, INC. 510(k) NO: K013994(SPECIAL) ATTN: KEN LOGSDON, JR. PHONE NO : 703-502-1486 14080-A SULLYFIELD CIRCLE SE DECISION MADE: 01-FEB-02 CHANTILLY, VA 20151 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T KOVEN TECHNOLOGY, INC. 510(k) NO: K010452(TRADITIONAL) ATTN: J. HARVEY KNAUSS PHONE NO : 713-723-4080 11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 12-FEB-02 HOUSTON, TX 77071-3404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PORTABLE NON-CONTACT TONOMETER, MODEL PT100 LEICA MICROSYSTEMS, INC. O.I.D. 510(k) NO: K013259(TRADITIONAL) ATTN: FRANK J DREXELIUS PHONE NO : 716-686-4548 3374 WALDEN AVE. SE DECISION MADE: 20-FEB-02 DEPEW, NY 14043 510(k) STATEMENT DEVICE: PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM (PVOCS) LITTON SYSTEMS, INC. 510(k) NO: K013223(TRADITIONAL) ATTN: GARY BYRD PHONE NO : 563-383-6299 2734 HICKORY GROVE ROAD SE DECISION MADE: 11-FEB-02 DAVENPORT, IA 52804 510(k) STATEMENT DEVICE: LUMEND FRONTRUNNER CTO CORONARY CATHETER LUMEND, INC. 510(k) NO: K013284(TRADITIONAL) ATTN: MICHAEL A DANIEL PHONE NO : 650-364-1400 400 CHESAPEAKE DR. SE DECISION MADE: 11-FEB-02 REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MACHNET BILATERAL OPEN BREAST COIL. CATALOG # MICS-GSXX MACHNET BV 510(k) NO: K013985(TRADITIONAL) ATTN: DANIEL KAMM PHONE NO : 847-374-1727 PO BOX 7007 SE DECISION MADE: 01-FEB-02 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDCOMP 14.5F DOUBLE LUMEN HEMODIALYSIS CATHETER MEDICAL COMPONENTS, INC. 510(k) NO: K012562(TRADITIONAL) ATTN: FLORENCE A CAIKOSKI PHONE NO : 215-256-4201 1499 DELP DR. SE DECISION MADE: 08-FEB-02 HARLEYSVILLE, PA 19438 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECTROSURGICAL CUTTING AND COAGULATION ACCESSORIES, ELECTROSURG MEDICAL INSTRUMENTS TECHNOLOGY, IN510(k) NO: K012640(TRADITIONAL) ATTN: JACK SPEER PHONE NO : 435-674-4010 385 NORTH 3050 EAST, SUITE B SE DECISION MADE: 28-FEB-02 ST. GEORGE, UT 84790 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDTRADE PRODUCTS SILICONE SCAR THERAPY GEL, SPENCO MEDICAL CORP MEDTRADE PRODUCTS LIMITED 510(k) NO: K014036(TRADITIONAL) ATTN: JONATHAN D RANFIELD PHONE NO : 440 127 0500019 7 THE BARNS, BRIDGEMERE SE DECISION MADE: 14-FEB-02 NANTWICH, UNITED KINGDOM CW5 7PF 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMA MEDTRONIC PHYSIO-CONTROL CORP. 510(k) NO: K012274(TRADITIONAL) ATTN: SHERRI L POCOCK PHONE NO : 425-867-4332 11811 WILLOWS RD NE SE DECISION MADE: 05-FEB-02 P.O. BOX 97006 510(k) SUMMARY AVAILABLE FROM FDA REDMOND, WA 98073-9706 DEVICE: MEDTRONIC PS MEDICAL STRATA VALVE, MODELS 42855, 42865, 92865, 9 MEDTRONIC PS MEDICAL 510(k) NO: K012052(TRADITIONAL) ATTN: JEFF HENDERSON PHONE NO : 805-968-1546 125 CREMONA DR., SE DECISION MADE: 11-FEB-02 UNIVERSITY BUSINESS CENTER 510(k) SUMMARY AVAILABLE FROM FDA GOLETA, CA 93117 DEVICE: DYNA-LOK CLASSIC SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K020155(SPECIAL) ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 05-FEB-02 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MSD WIRE SYSTEM MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K020426(SPECIAL) ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 26-FEB-02 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STEALTHSTATION WITH FLUOROMERGE SOFTWARE MEDTRONIC SURGICAL NAVIGATION TECH510(k) NO: K020338(SPECIAL) ATTN: VICTORIA G RENDON PHONE NO : 720-890-3200 826 COAL CREEK CIR. SE DECISION MADE: 27-FEB-02 LOUISVILLE, CO 80027 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODEL 9210 DELIVERY CATHETER, MODEL 9210 MEDTRONIC, INC. 510(k) NO: K013963(TRADITIONAL) ATTN: MARY E BEST PHONE NO : 763-514-4846 7000 CENTRAL AVENUE NE SE DECISION MADE: 28-FEB-02 MINNEAPOLIS, MN 55432-3576 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS MERITS HEALTH PRODUCTS CO., LTD. 510(k) NO: K014301(SPECIAL) ATTN: LEE LEICHTER PHONE NO : 941-786-1118 7690 CAMERON CIRCLE SE DECISION MADE: 11-FEB-02 FORT MYERS, FL 33912 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XERAFIT METALOR TECHNOLOGIES USA 510(k) NO: K020062(TRADITIONAL) ATTN: BRUCE A BARTON PHONE NO : 800-554-5504 255 JOHN L. DIETSCH BLVD. SE DECISION MADE: 14-FEB-02 NORTH ATTLEBOROUGH, MA 02761 510(k) STATEMENT DEVICE: A1CNOW FOR RX HOME USE METRIKA, INC. 510(k) NO: K020234(SPECIAL) ATTN: ERIKA AMMIRATI PHONE NO : 408-524-2255 510 OAKMEAD PKWY. SE DECISION MADE: 15-FEB-02 SUNNYVALE, CA 94085-4022 510(k) STATEMENT DEVICE: A1CNOW FOR PROFESSIONAL USE METRIKA, INC. 510(k) NO: K020235(SPECIAL) ATTN: ERIKA AMMIRATI PHONE NO : 408-524-2255 510 OAKMEAD PKWY. SE DECISION MADE: 15-FEB-02 SUNNYVALE, CA 94085-4022 510(k) STATEMENT DEVICE: MICROLIGHT 830 LASER SYSTEM MICROLIGHT CORPORATION OF AMERICA 510(k) NO: K010175(TRADITIONAL) ATTN: MICHAEL BARBOUR PHONE NO : 713-777-5477 2935 HIGHLAND LAKES SE DECISION MADE: 06-FEB-02 MISSOURI CITY, TX 77459 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MB 103 MILLENNIUM BLADES MILLENNIUM BIOMEDICAL, INC. 510(k) NO: K011833(TRADITIONAL) ATTN: JERRY KAENI PHONE NO : 909-621-7646 360 EAST BONITA AVE. SE DECISION MADE: 15-FEB-02 POMONA, CA 91767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MB 102 MILLENNIUM BLADES MILLENNIUM BIOMEDICAL, INC. 510(k) NO: K020122(TRADITIONAL) ATTN: JERRY KAENI PHONE NO : 909-621-7646 360 EAST BONITA AVE. SE DECISION MADE: 15-FEB-02 POMONA, CA 91767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER MINNTECH CORP. 510(k) NO: K014016(TRADITIONAL) ATTN: LYNN LUCDERS PHONE NO : 763-553-2475 14605 28TH AVE. NORTH SE DECISION MADE: 01-FEB-02 MINNEAPOLIS, MN 55447 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RIDIDFIX 2.7MM BTB CROSS PIN KIT MITEK PRODUCTS 510(k) NO: K013781(TRADITIONAL) ATTN: JENNIFER JOHNSON PHONE NO : 781-251-2704 249 VANDERBILT AVENUE SE DECISION MADE: 06-FEB-02 NORWOOD, MA 02090 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXS-63 SMALL EXTREMITY ARRAY COIL MRI DEVICES CORP. 510(k) NO: K020036(SPECIAL) ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402 1515 PARAMOUNT DR. SE DECISION MADE: 01-FEB-02 WAUKESHA, WI 53186 510(k) STATEMENT DEVICE: WAVELENGHT ULTRASOUND LOTION NATIONAL THERAPY PRODUCTS INC. 510(k) NO: K013212(TRADITIONAL) ATTN: PAUL L HOOEY PHONE NO : 905 264 5600 2-191 ROWNTREE DAIRY RD. SE DECISION MADE: 25-FEB-02 WOODBRIDGE, ONTARIO, CANADA LHL 8B510(k) STATEMENT DEVICE: VASCUPUNCTURE ACCESS WIRE NEO METRICS, INC. 510(k) NO: K012861(TRADITIONAL) ATTN: GENE CHAMPEAU PHONE NO : 763-559-4440 15301 HIGHWAY 55 WEST SE DECISION MADE: 05-FEB-02 MINNEAPOLIS, MN 55447 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DFINER UROLOGICAL CATHETER NEOSEED TECHNOLOGY,LLC 510(k) NO: K013360(TRADITIONAL) ATTN: MARK KIERAS PHONE NO : 978-463-4086 22 HILL STREET SE DECISION MADE: 20-FEB-02 NEWBURYPORT, MA 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DC-3300 LASER DIODE PHOTOCOAGULATOR NIDEK, INC. 510(k) NO: K013760(TRADITIONAL) ATTN: CAROL PATTERSON PHONE NO : 949-462-0900 21911 ERIE LANE SE DECISION MADE: 11-FEB-02 LAKE FOREST, CA 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO EPI-STAR SURGICAL LASER SYSTEM, M0DEL DS-60 NIDEK, INC. 510(k) NO: K013864(TRADITIONAL) ATTN: CAROL PATTERSON PHONE NO : 949-462-0900 21911 ERIE LANE SE DECISION MADE: 08-FEB-02 LAKE FOREST, CA 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STAT PROFILE PHOX ANALYZER NOVA BIOMEDICAL CORP. 510(k) NO: K014295(TRADITIONAL) ATTN: PAUL W MAC DONALD PHONE NO : 781-894-0800 200 PROSPECT ST. SE DECISION MADE: 28-FEB-02 WALTHAM, MA 02454-9141 510(k) STATEMENT DEVICE: INCLUDER CLAMP NOVARE SURGICAL SYSTEMS, INC. 510(k) NO: K010694(TRADITIONAL) ATTN: TERRY BUELNA PHONE NO : 408-350-9911 10231 BUBB RD. SE DECISION MADE: 11-FEB-02 CUPERTINO, CA 95014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: "ARIEL" RADIO FREQUENCY (RF) ELECTROSURGICAL CONTROL MODULE AND NOVASYS MEDICAL, INC. 510(k) NO: K013730(TRADITIONAL) ATTN: THOMAS C WEHMAN PHONE NO : 408-720-6321 687 NO. PASTORIA AVENUE SE DECISION MADE: 06-FEB-02 SUNNYVALE, CA 94086 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEUROSENSOR NOVUS MONITORING LTD 510(k) NO: K013930(TRADITIONAL) ATTN: PETER F GIBSON PHONE NO : 441 264 711080 ABBOTTS ANN, ANDOVER SE DECISION MADE: 20-FEB-02 HAMPSHIRE 510(k) SUMMARY AVAILABLE FROM FDA UNITED KINGDOM, UNITED KINGDOM SP11 7BH DEVICE: NXSTAGE DIALYSATE CONCENTRATE, MODEL RFC-100 NXSTAGE MEDICAL, INC. 510(k) NO: K013655(TRADITIONAL) ATTN: KAREN ST. ONGE PHONE NO : 978-687-4700 439 SOUTH UNION STREET SE DECISION MADE: 04-FEB-02 SUITE 501 510(k) SUMMARY AVAILABLE FROM FDA S. LAWRENCE, MA 01843 DEVICE: OLYMPUS HDL CHOLESTEROL REAGENT; OLYMPUS HDL CHOLESTEROL CALIBRA OLYMPUS AMERICA, INC. 510(k) NO: K014015(TRADITIONAL) ATTN: MICHAEL CAMPBELL PHONE NO : 972-556-9697 3131 WEST ROYAL LANE SE DECISION MADE: 08-FEB-02 IRVING, TX 75063-3104 510(k) STATEMENT DEVICE: OLYMPUS LDL CHOLESTEROL REAGENT, OLYMPUS LDL CHOLESTEROL CALIBRA OLYMPUS AMERICA, INC. 510(k) NO: K014032(TRADITIONAL) ATTN: MICHAEL CAMPBELL PHONE NO : 972-556-9697 3131 WEST ROYAL LANE SE DECISION MADE: 08-FEB-02 IRVING, TX 75063-3104 510(k) STATEMENT DEVICE: P.O.G.S. 3.3 PORTABLE OXYGEN GENERATOR SYSTEM ON SITE GAS SYSTEMS INC. 510(k) NO: K020362(TRADITIONAL) ATTN: C. BARTON GULLONG PHONE NO : 860-667-8888 35 BUDNEY ROAD SE DECISION MADE: 12-FEB-02 BUDNEY PARK INDUSTRIAL 510(k) SUMMARY AVAILABLE FROM FDA NEWINGTON, CT 06111 DEVICE: OVUS CAPLESS SAFETY NEEDLE OVUS SYSTEMS 510(k) NO: K013006(TRADITIONAL) ATTN: T. WHIT ATHEY PHONE NO : 301-770-9590 12300 TWINBROOK PKWY, STE 625 SE DECISION MADE: 06-FEB-02 ROCKVILLE, MD 20852 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PADPRO, MODEL 2603 PADPRO LLC. 510(k) NO: K020288(SPECIAL) ATTN: DANIEL KAMM PHONE NO : 847-374-1727 P.O.BOX 7007 SE DECISION MADE: 27-FEB-02 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STONELITH, MODEL V5 PCK ELECTRONIC INDUSTRY AND TRADE 510(k) NO: K011106(TRADITIONAL) ATTN: CENGIZ KABAKCI PHONE NO : 903 124 916010 59/1 SANCAK, CANKAYA SE DECISION MADE: 11-FEB-02 ANKARA, TURKEY 06550 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EG-3630UR, ULTRASUND VIDEO GASTROSCOPE PENTAX PRECISION INSTRUMENT CORP. 510(k) NO: K013640(TRADITIONAL) ATTN: PAUL SILVA PHONE NO : 914-365-0700 30 RAMLAND ROAD SE DECISION MADE: 04-FEB-02 ORANGEBURG, NY 10962 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE E.0 PHILIPS MEDICAL SYSTEMS, INC. 510(k) NO: K014261(SPECIAL) ATTN: DAVE OSBORN PHONE NO : 978-659-3178 3000 MINUTEMAN RD. SE DECISION MADE: 12-FEB-02 ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO M2376A DEVICELINK SYSTEM PHILIPS MEDICAL SYSTEMS, INC. 510(k) NO: K020494(SPECIAL) ATTN: MIKE HUDON PHONE NO : 978-659-3173 3000 MINUTEMAN RD. MS 0491 SE DECISION MADE: 21-FEB-02 ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODUL PHOENIX DIAGNOSTICS, INC. 510(k) NO: K020129(TRADITIONAL) ATTN: RAM NUNNA PHONE NO : 508-655-8310 8 TECH CIRCLE SE DECISION MADE: 01-FEB-02 NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHOENOIX ISE REAGENTS FOR OLYMPUS AU SERIES PHOENIX DIAGNOSTICS, INC. 510(k) NO: K020148(TRADITIONAL) ATTN: RAM NUNNA PHONE NO : 508-655-8310 8 TECH CIRCLE SE DECISION MADE: 04-FEB-02 NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SLIM GLIDING NAIL SYSTEM PLUS ORTHOPEDICS 510(k) NO: K020240(SPECIAL) ATTN: HARTMUT LOCH PHONE NO : 858-550-3800 6055 LUSK BLVD. SE DECISION MADE: 22-FEB-02 SAN DIEGO, CA 92121-2700 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BABYCOM PMG MEDICA LTD. 510(k) NO: K013547(TRADITIONAL) ATTN: ELI M ORBACH PHONE NO : 972 299 32768 POB 6718 SE DECISION MADE: 20-FEB-02 EFRAT, ISRAEL 90435 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIBERTY BLOOD GLUCOSE MONITORING SYSTEM POLYMEDICA PHARMACEUTICALS, U.S.A.510(k) NO: K014167(TRADITIONAL) ATTN: PATRICIA COLLINS PHONE NO : 781-933-2020 11 STATE STREET SE DECISION MADE: 19-FEB-02 WOBURN, MA 01801 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTEC PORTEX, INC. 510(k) NO: K014073(TRADITIONAL) ATTN: BRAIN E FARIAS PHONE NO : 603-352-3812 10 BOWMAN DR. SE DECISION MADE: 13-FEB-02 KEENE, NH 03431 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHOSIS HELMET MOLDING PRECISION PROSTHETICS & ORTHOTICS,510(k) NO: K013700(TRADITIONAL) ATTN: CONNIE FICKLIN PHONE NO : 952-946-8080 5353 WAYZATA BLVD. STE 505 SE DECISION MADE: 05-FEB-02 MINNEAPOLIS, MN 55416-1334 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRIME-DENT HEMA DESENSITIZER PRIME DENTAL MANUFACTURING, INC. 510(k) NO: K013970(TRADITIONAL) ATTN: ROLANDO MARASIGAN PHONE NO : 773-539-5927 3735 WEST BELMONT AVE. SE DECISION MADE: 19-FEB-02 CHICAGO, IL 60618 510(k) STATEMENT DEVICE: VINYL EXAMINATION GLOVES STERILE POWEDERED PRIMUS GLOVES PRIVATE LTD. 510(k) NO: K020044(TRADITIONAL) ATTN: JOSEPH J E PEREIRA PHONE NO : 914 844 21983 PLOT NO:14-A COCHIN SPECIAL SE DECISION MADE: 26-FEB-02 ECONOMIC ZONE 510(k) STATEMENT KAKKANAD, KOCHI, KERALA, INDIA 682 030 DEVICE: JB-70 INTRAORAL X-RAY SYSTEM, MODELS 30-A0001/A0002 PROGENY, INC. 510(k) NO: K020070(TRADITIONAL) ATTN: ALAN KREMA PHONE NO : 847-850-3800 1407 BARCLAY BLVD. SE DECISION MADE: 01-FEB-02 BUFFALO GROVE, IL 60089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PSYCHEMEDICS RIA PHENCYCLIDINE ASSAY PSYCHEMEDICS CORP. 510(k) NO: K011275(TRADITIONAL) ATTN: THOMAS CAIRNS PHONE NO : 617-868-7455 5832 UPLANDER WAY SE DECISION MADE: 11-FEB-02 CULVER CITY, CA 90230 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LATEX POWDERFREE STERILE EXAMINATION GLOVES, MODELS-EXTRA SMALL, PT. MAJA AGUNG LATEXINDO 510(k) NO: K013996(TRADITIONAL) ATTN: EMMY T JOENG PHONE NO : 909-591-8855 5445 DANIEL STREET SE DECISION MADE: 26-FEB-02 CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVE PULPDENT CORP. 510(k) NO: K014059(TRADITIONAL) ATTN: KENNETH J BERK PHONE NO : 617-926-6666 80 OAKLAND STREET SE DECISION MADE: 27-FEB-02 WATERTOWN, MA 02472 510(k) STATEMENT DEVICE: PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM PULPDENT CORP. 510(k) NO: K020115(TRADITIONAL) ATTN: KENNETH J BERK PHONE NO : 617-926-6666 80 OAKLAND STREET SE DECISION MADE: 28-FEB-02 WATERTOWN, MA 02472 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: R & D BODY FLUID CONTROL R & D SYSTEMS, INC. 510(k) NO: K020229(TRADITIONAL) ATTN: RALPH E HOGANCAMP PHONE NO : 612-656-4413 614 MCKINLEY PL., N.E. SE DECISION MADE: 06-FEB-02 MINNEAPOLIS, MN 55413 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DENTALEYE 2 DENTAL IMAGE MANAGEMENT SYSTEM RADCO DATA AB 510(k) NO: K012439(TRADITIONAL) ATTN: DANIEL KAMM PHONE NO : 847-374-1727 P.O. BOX 7007 SE DECISION MADE: 06-FEB-02 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INFRARED EAR THERMOMETER, MODELS TH88 SERIES RADIANT INNOVATION, INC. 510(k) NO: K020504(SPECIAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001 55 NORTHERN BLVD SE DECISION MADE: 28-FEB-02 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA GREAT NECK, NY 11021 DEVICE: RESPIRONICS HEATED HUMIDIFIER RESPIRONICS, INC. 510(k) NO: K012633(TRADITIONAL) ATTN: DAVID J VANELLA PHONE NO : 724-733-5866 1001 MURRY RIDGE LANE SE DECISION MADE: 28-FEB-02 MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENAMEL BONDING SYSTEM RITE-DENT MANUFACTURING CORP. 510(k) NO: K020050(TRADITIONAL) ATTN: CESAR E VELIZ PHONE NO : 305-693-8626 1056 EAST 33RD ST. SE DECISION MADE: 14-FEB-02 HIALEAH, FL 33013-3526 510(k) STATEMENT DEVICE: ROCHE COBAS TAQMAN ANALYZER ROCHE MOLECULAR SYSTEMS, INC. 510(k) NO: K012966(TRADITIONAL) ATTN: GARY S RIORDAN PHONE NO : 925-730-8350 4300 HACIENDA DRIVE SE DECISION MADE: 01-FEB-02 PLEASANTON, CA 94588-2722 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RUSCH MILLER-ABBOTT TUBE RUSCH INTL. 510(k) NO: K010797(TRADITIONAL) ATTN: JULIE A BEAUMONT PHONE NO : 603-532-7706 50 PLANTATION DRIVE SE DECISION MADE: 26-FEB-02 JAFFERY, NH 03452 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RUSCH CANTOR TUBE RUSCH INTL. 510(k) NO: K010798(TRADITIONAL) ATTN: JULIE A BEAUMONT PHONE NO : 603-532-0204 50 PLANTATION DRIVE SE DECISION MADE: 26-FEB-02 JAFFERY, NH 03452 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RUSCH MEMORY BAG RUSCH INTL. 510(k) NO: K013872(TRADITIONAL) ATTN: RICK LYKINS PHONE NO : 603-532-7706 50 PLANTATION DRIVE SE DECISION MADE: 12-FEB-02 JAFFERY, NH 03452 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SALTER LABS MODIFIED NEBUTECH NEBULIZER SALTER LABS 510(k) NO: K014056(SPECIAL) ATTN: DUANE KAZAL PHONE NO : 661-854-3166 100 W. SYCAMORE ROAD SE DECISION MADE: 01-FEB-02 ARVIN, CA 93203 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SANDHILL SCIENTIFIC PEDIATEC PH PROBE SANDHILL SCIENTIFIC, INC. 510(k) NO: K013951(TRADITIONAL) ATTN: LEWIS WARD PHONE NO : 303-530-3279 4655 KIRKWOOD CT SE DECISION MADE: 28-FEB-02 BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO ISOBAR SPINAL SYSTEM SCIENT'X 510(k) NO: K020245(SPECIAL) ATTN: JOANNA DROEGE PHONE NO : 512-834-6255 9800 METRIC BLVD. SE DECISION MADE: 01-FEB-02 AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPIROLAB II, MODEL 29 SDI DIAGNOSTICS, INC. 510(k) NO: K013812(TRADITIONAL) ATTN: MICHAEL J BOYLE PHONE NO : 508-238-7033 10 HAMPDEN DR. SE DECISION MADE: 11-FEB-02 EASTON, MA 02375 510(k) STATEMENT DEVICE: PORTABLE X-RAY UNITS; MODELS SP-HF-2.8 & SP-HF-4.0 SEDECAL S.A. 510(k) NO: K020436(ABBREVIATED) ATTN: DANIEL KAMM PHONE NO : 847-374-1727 PO BOX 7007 SE DECISION MADE: 22-FEB-02 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENSAID SENSIDYNE, INC. 510(k) NO: K011974(TRADITIONAL) ATTN: GEORGE MASON PHONE NO : 727-530-3602 16333 BAY VISTA DRIVE SE DECISION MADE: 12-FEB-02 CLEARWATER, FL 33760 510(k) STATEMENT DEVICE: PYLORITEK VP TEST KIT 5140VP SERIM RESEARCH CORP. 510(k) NO: K014038(TRADITIONAL) ATTN: PATRICIA RUPUCHOCK PHONE NO : 574-264-3440 23565 REEDY DR. SE DECISION MADE: 08-FEB-02 ELKHART, IN 46514 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY; THREE WAY, RADIOPA SEWOON MEDICAL CO., LTD. 510(k) NO: K013276(TRADITIONAL) ATTN: DANIEL KAMM PHONE NO : 847-374-1727 PO BOX 7007 SE DECISION MADE: 15-FEB-02 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NON-STERILE POWDER FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE CO SGMP CO., LTD. 510(k) NO: K020317(TRADITIONAL) ATTN: JANNA TUCKER PHONE NO : 775-342-2612 198 AVENUE DE LA D'EMERALD SE DECISION MADE: 14-FEB-02 SPARKS, NV 89434 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE LAVENDER/PURPLE NITRILE EXAM GLOVES SHEEN MORE ENT. CO., LTD. 510(k) NO: K013998(TRADITIONAL) ATTN: JANNA P TUCKER PHONE NO : 775-342-2612 198 AVENUE DE LA D'EMERALD SE DECISION MADE: 13-FEB-02 SPARKS, NV 89434-9550 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE (BLUE) NITRILE PATIENT EXAMINATION GLOVES SHIJIAZHUANG GREAT VISION PLASTIC 510(k) NO: K014077(TRADITIONAL) ATTN: JAMES CHU PHONE NO : 909-548-4828 12390 EAST END AVENUE SE DECISION MADE: 04-FEB-02 CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SATARI POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LA SIAM SEMPERMED CORP. LTD. 510(k) NO: K014110(ABBREVIATED) ATTN: JAY MANSOUR PHONE NO : 678-908-8180 1308 MORNINGSIDE PARK DR. SE DECISION MADE: 28-FEB-02 ALPHARETTA, GA 30022 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SATARI LATEX PATIENT EXAMINATION POWDERED GLOVE SINGLE SIDE POLY SIAM SEMPERMED CORP. LTD. 510(k) NO: K014112(ABBREVIATED) ATTN: JAY MANSOUR PHONE NO : 678-908-8180 1308 MORNINGSIDE PARK DR. SE DECISION MADE: 28-FEB-02 ALPHARETTA, GA 30022 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIEMENS INFINITY SC 6002XL MODIFICATIONS SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K020144(SPECIAL) ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500 16 ELECTRONICS AVENUE SE DECISION MADE: 15-FEB-02 DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIEMENS MEDICAL INFROMATION BUS (MIB II) PROTOCOL CONVERTER SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K020277(SPECIAL) ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500 16 ELECTRONICS AVE. SE DECISION MADE: 19-FEB-02 DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM) SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K013826(TRADITIONAL) ATTN: SANDRA ROBINSON PHONE NO : 732-321-3243 186 WOOD AVENUE SOUTH SE DECISION MADE: 01-FEB-02 ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OMNIA X/XS ULTRASOUND SYSTEM SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K020353(TRADITIONAL) ATTN: JUDI HOFFMAN PHONE NO : 425-557-1229 22010 SE 51ST STREET SE DECISION MADE: 13-FEB-02 ISSAQUAH, WA 98029 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM SIERRA DIAGNOSTIC, L.L.C. 510(k) NO: K013819(TRADITIONAL) ATTN: DONALD R STONE PHONE NO : 202-778-9067 1800 MASSACHUSETTS AVE., NW SE DECISION MADE: 28-FEB-02 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20036-1221 DEVICE: SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL SIGMA DIAGNOSTICS, INC. 510(k) NO: K020109(TRADITIONAL) ATTN: WILLIAM R GILBERT PHONE NO : 314-286-6693 545 SOUTH EWING AVE. SE DECISION MADE: 06-FEB-02 ST. LOUIS, MO 63103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HANDHELD GAMMA FINDER (HGF) SILICON INSTRUMENTS GMHB 510(k) NO: K013751(TRADITIONAL) ATTN: THOMAS GOEBEL PHONE NO : 493 063 992360 OSTENDSTRASSE 1 SE DECISION MADE: 06-FEB-02 BERLIN, GERMANY D-12459 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHE SIMS PORTEX LTD. 510(k) NO: K012277(TRADITIONAL) ATTN: STEVEN OGILVIE PHONE NO : 44 130 3260551 HYTHE SE DECISION MADE: 11-FEB-02 HYTHE, KENT, UNITED KINGDOM CT 21 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX SIMS PORTEX, INC. 510(k) NO: K014115(TRADITIONAL) ATTN: TIMOTHY J TALCOTT PHONE NO : 603-352-3812 10 BOWMAN DR. SE DECISION MADE: 27-FEB-02 KEENE, NH 03431 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DYONICS ELECTROBLADE RESECTOR SMITH & NEPHEW, INC. 510(k) NO: K012314(TRADITIONAL) ATTN: TIM CRABTREE PHONE NO : 978-749-1068 160 DASCOMB RD. SE DECISION MADE: 01-FEB-02 ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR KNEE APPLIC SMITH & NEPHEW, INC. 510(k) NO: K012938(ABBREVIATED) ATTN: TRUDE C NAFF PHONE NO : 901-396-2121 1450 E. BROOKS ROAD SE DECISION MADE: 08-FEB-02 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDO-GLIDE SONOTECH, INC. 510(k) NO: K013701(TRADITIONAL) ATTN: MARGARET J LARSON PHONE NO : 360-671-9121 774 MARINE DR. SE DECISION MADE: 04-FEB-02 BELLINGHAM, WA 98225 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPECTRAL'S TROPONIN I SPECTRAL DIAGNOSTICS, INC. 510(k) NO: K014105(TRADITIONAL) ATTN: NISAR A SHAIKH PHONE NO : 416 626 3233 135-2 THE WEST MALL SE DECISION MADE: 01-FEB-02 TORONTO, ONTARIO, CANADA M9C1C2 510(k) STATEMENT DEVICE: BACFIX SPINAL FIXATION SYSTEM SPINAL CONCEPTS, INC. 510(k) NO: K013887(TRADITIONAL) ATTN: DAVID M HOPPER PHONE NO : 512-918-2700 12012 TECHNOLOGY BLVD., #100 SE DECISION MADE: 12-FEB-02 AUSTIN, TX 78727 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SC-ACUFIX THINLINE ANTERIOR CERVICAL PLATE SYSTEM SPINAL CONCEPTS, INC. 510(k) NO: K013979(SPECIAL) ATTN: DAVID M HOOPER PHONE NO : 512-918-2700 12012 TECHNOLOGY BLVD., #100 SE DECISION MADE: 13-FEB-02 AUSTIN, TX 78727 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNI-T SPINAL SYSTEM SPINEVISION, INC. 510(k) NO: K013301(TRADITIONAL) ATTN: LYNNETTE WHITAKER PHONE NO : 574-269-9776 3003 SUMMIT BLVD.; STE 1500 SE DECISION MADE: 13-FEB-02 ATLANTA, GA 30319 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: P.L.U.S. SYSTEM (PIVOT LINK UNIVERSAL SYSTEM) SPINEVISION, INC. 510(k) NO: K013312(TRADITIONAL) ATTN: LYNNETTE WHITAKER PHONE NO : 574-269-9776 3003 SUMMIT BLVD.; STE 1500 SE DECISION MADE: 13-FEB-02 ATLANTA, GA 30319 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEOCALEX STEPHEN M KORAL, DMD 510(k) NO: K013993(TRADITIONAL) ATTN: STEPHEN M KORAL PHONE NO : 303-443-4984 2006 BROADWAY SE DECISION MADE: 22-FEB-02 BOULDER, CO 80302 510(k) STATEMENT DEVICE: REPROCESSED ELECTRIC SNARES STERILMED, INC. 510(k) NO: K012555(TRADITIONAL) ATTN: PATRICK FLEISCHHACKER PHONE NO : 888-856-4870 11400 73RD AVE. NORTH SE DECISION MADE: 14-FEB-02 MAPLE GROVE, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED STONE RETRIEVAL BASKETS STERILMED, INC. 510(k) NO: K012581(TRADITIONAL) ATTN: PATRICK FLEISCHHACKER PHONE NO : 888-856-4870 11400 73RD AVE N., SUITE 100 SE DECISION MADE: 14-FEB-02 MAPLE GROVE, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED ENDOSCOPIC ELECTROSURGICAL BIOPSY FORCEPS STERILMED, INC. 510(k) NO: K012596(TRADITIONAL) ATTN: PATRICK FLEISCHHACKER PHONE NO : 763-488-3400 11400 73RD AVE N., SUITE 100 SE DECISION MADE: 14-FEB-02 MAPLE GROVE, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERILMED REPROCESSED COMPRESSION SLEEVES STERILMED, INC. 510(k) NO: K012597(TRADITIONAL) ATTN: PATRICK FLEISCHHACKER PHONE NO : 888-856-4870 11400 73RD AVE. NORTH SE DECISION MADE: 11-FEB-02 MAPLE GROVE, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED ENDOSCOPIC ELECTRODES STERILMED, INC. 510(k) NO: K012685(TRADITIONAL) ATTN: PATRICK FLEISCHHACKER PHONE NO : 888-856-4870 11400 73RD AVE. NORTH SE DECISION MADE: 14-FEB-02 MAPLE GROVE, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CENTRIFUGAL PUMP STOCKERT INSTRUMENTE GMBH 510(k) NO: K011838(TRADITIONAL) ATTN: ROSINA ROBINSON PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 05-FEB-02 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM SULZER SPINE-TECH 510(k) NO: K020196(SPECIAL) ATTN: KRISTYN M BENSON PHONE NO : 952-830-6273 7375 BUSH LAKE RD. SE DECISION MADE: 15-FEB-02 MINNEAPOLIS, MN 55439-2027 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AURELIA CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVE SUPERMAX GLOVE MANUFACTURING SDN B510(k) NO: K013953(TRADITIONAL) ATTN: STANLEY THAI PHONE NO : 603 615 72328 LOT 42, PUTRA INDUSTRIAL PARK SE DECISION MADE: 26-FEB-02 BUKIT RAHMAN PUTRA 510(k) STATEMENT SUNGAI BULOH, SELANGOR, MALAYSIA 47000 DEVICE: FIRSTSAVE STAR BIPHASIC, MODEL 9210/9200 SURVIVALINK CORP. 510(k) NO: K011901(TRADITIONAL) ATTN: JOHN CARLINE PHONE NO : 952-939-2978 5420 FELTL RD. SE DECISION MADE: 01-FEB-02 MINNEAPOLIS, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TEMPFIL SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K013895(TRADITIONAL) ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484 1717 WEST COLLINS AVENUE SE DECISION MADE: 04-FEB-02 ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMORY CARDIAC TOOLBOX 2.1 EXECUTING ON NUCLEAR MEDICINE COMPUTER SYNTERMED, INC. 510(k) NO: K014033(TRADITIONAL) ATTN: KENNETH F VAN TRAIN PHONE NO : 714-281-1256 245 OWENS DRIVE SE DECISION MADE: 22-FEB-02 ANAHEIM, CA 92808 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE SYNTEX HEALTHCARE PRODUCTS CO. LTD510(k) NO: K020493(TRADITIONAL) ATTN: TAN SWU CHOON PHONE NO : 86 311 3275480 NO. 1 FANJIAZHUNG INDUSTRIAL SE DECISION MADE: 26-FEB-02 ZONE 510(k) STATEMENT XINJI CITY, HEBEI PROVINCE, CHINA 0252360 DEVICE: FAST SET PUTTY SYNTHES (USA) 510(k) NO: K012589(TRADITIONAL) ATTN: THOMAS M MAGUIRE PHONE NO : 610-647-9700 1690 RUSSELL RD. SE DECISION MADE: 07-FEB-02 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES METALLIC SPIKED WASHERS SYNTHES (USA) 510(k) NO: K013806(TRADITIONAL) ATTN: MATTHEW M HULL PHONE NO : 610-647-9700 1690 RUSSELL RD. SE DECISION MADE: 08-FEB-02 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES CRANIAL PLATES SYNTHES (USA) 510(k) NO: K020087(TRADITIONAL) ATTN: MATTHEW M HULL PHONE NO : 610-647-9700 1690 RUSSELL RD. SE DECISION MADE: 20-FEB-02 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOTECH B990K VIVI WHEELCHAIR TAIWAN ARMADA ENTERPRISE CO., LTD.510(k) NO: K014198(TRADITIONAL) ATTN: KE-MIN JEN PHONE NO : 886 352 08829 NO. 58, FU-CHIUN ST. SE DECISION MADE: 01-FEB-02 HSIN-CHU CITY, CHINA (TAIWAN) 510(k) STATEMENT DEVICE: BIOTECH MANUAL WHEELCHAIR A2000 SUPER MOTIVE WHEELCHAIR TAIWAN ARMADA ENTERPRISE CO., LTD.510(k) NO: K020284(TRADITIONAL) ATTN: KE-MIN JEN PHONE NO : 886 352 08829 NO. 58, FU-CHIUN ST. SE DECISION MADE: 08-FEB-02 HSIN-CHU CITY, CHINA (TAIWAN) 510(k) STATEMENT DEVICE: OMEGATRAC, MODEL Z105 TEFTEC CORP. 510(k) NO: K013307(TRADITIONAL) ATTN: THOMAS E FINCH, III PHONE NO : 210-477-0330 12450 NETWORK BLVD. SE DECISION MADE: 08-FEB-02 SAN ANTONIO, TX 78249 510(k) STATEMENT DEVICE: TEKNO-MEDICAL OBSTETRICAL FORCEPS TEKNO MEDICAL OPTIK-CHIRURGIE GMBH510(k) NO: K013747(ABBREVIATED) ATTN: MARKUS DENK PHONE NO : 004 974 6496600 KAISERSTR 9 SE DECISION MADE: 11-FEB-02 TUNINGEN, BADEN-WURTENBERG, GERMAN510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO TRANSSEPTAL INTRODUCER SET THOMAS MEDICAL PRODUCTS, INC. 510(k) NO: K020090(SPECIAL) ATTN: TIM STOUDT PHONE NO : 610-296-3000 65 GREAT VALLEY PKWY. SE DECISION MADE: 11-FEB-02 MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ERECAID CLASSIC SYSTEM; ERECAID ESTEEM MANUAL SYSTEM; ERECAID ES TIMM MEDICAL TECHNOLOGIES, INC. 510(k) NO: K020082(SPECIAL) ATTN: CHRIS HADLAND PHONE NO : 952-947-9410 6585 CITY WEST PKWY. SE DECISION MADE: 05-FEB-02 EDEN PRAIRIE, MN 55344 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLYCOAT POWDERED LATEX EXAMINATION GLOVE WITH ALOE VERA & PROTE TOP QUALITY MFG., INC. 510(k) NO: K013254(TRADITIONAL) ATTN: ART WARD PHONE NO : 813-645-2855 962 ALLEGRO LANE SE DECISION MADE: 04-FEB-02 APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CGS-30A MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, MODEL TS TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K020385(TRADITIONAL) ATTN: PAUL BIGGINS PHONE NO : 714-730-5000 2441 MICHELLE DR. SE DECISION MADE: 15-FEB-02 P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA TUSTIN, CA 92781-2068 THIRD PARTY REVIEW DEVICE: SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K014258(TRADITIONAL) ATTN: CYNTHIA C KNAPP PHONE NO : 800-216-9036 29299 CLEMENS RD. SUITE 1-K SE DECISION MADE: 19-FEB-02 WESTLAKE, OH 44145 510(k) STATEMENT DEVICE: AEROPEP TRUDELL MEDICAL INTL. 510(k) NO: K012368(TRADITIONAL) ATTN: TOM HOLBROOK PHONE NO : 519 455 7060 725 THIRD ST. SE DECISION MADE: 12-FEB-02 LONDON, ONTARIO, CANADA N5V 5G4 510(k) STATEMENT DEVICE: SPIRABRUSH CX BIOPSY INSTRUMENT TRYLON CORP. 510(k) NO: K011488(TRADITIONAL) ATTN: MARTIN LONKY PHONE NO : 310-327-8820 970 WEST 190TH ST., SUITE 850 SE DECISION MADE: 22-FEB-02 TORRANCE, CA 90502-1037 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TUTA HEALTHCARE ARTHROSCOPY FLUSHING SET, MODEL 80.601 TUTA HEALTHCARE PTY LIMITED 510(k) NO: K020083(TRADITIONAL) ATTN: OMID SOURESRAFIL PHONE NO : 612 942 70300 318-332 BURNS BAY ROAD SE DECISION MADE: 12-FEB-02 LANE COVE 510(k) SUMMARY AVAILABLE FROM FDA SYDNEY NSW, AUSTRALIA 2066 DEVICE: BRACE EZE UDENT, INC. 510(k) NO: K020009(TRADITIONAL) ATTN: MANAR JAMAL PHONE NO : 909-623-0409 676 FAIRPLEX DRIVE SE DECISION MADE: 11-FEB-02 POMONA, CA 91768 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEARPLANE EASY OVULATION TEST UNIPATH LTD. 510(k) NO: K013874(TRADITIONAL) ATTN: STEVEN H ARMSTRONG PHONE NO : 212-418-8515 390 PARK AVENUE SE DECISION MADE: 19-FEB-02 NEW YORK, NY 10022-4698 510(k) STATEMENT DEVICE: SURGICAL DYNAMICS OGDEN SUTURE ANCHOR WITH SUTURE UNITED STATES SURGICAL 510(k) NO: K020352(SPECIAL) ATTN: TINA RIDEOUT PHONE NO : 203-845-4520 150 GLOVER AVE. SE DECISION MADE: 26-FEB-02 NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MARK 5000 QUADRATURE SHOULDER COIL USA INSTRUMENTS, INC. 510(k) NO: K013854(TRADITIONAL) ATTN: TORI MASIELLA PHONE NO : 330-562-1000 1515 DANNER DRIVE SE DECISION MADE: 06-FEB-02 AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CTL BODY / SPINE ARRAY COIL USA INSTRUMENTS, INC. 510(k) NO: K014086(TRADITIONAL) ATTN: RONY THOMAS PHONE NO : 330-562-1000 1515 DANNER DRIVE SE DECISION MADE: 05-FEB-02 AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VCS-A SERIES CLAMP VASCULAR CONTROL SYSTEMS, INC 510(k) NO: K011863(TRADITIONAL) ATTN: AL MEMMOLO PHONE NO : 949-488-8700 32236- E PASEO ADELANTO SE DECISION MADE: 15-FEB-02 SAN JUAN CAPISTRANO, CA 92675 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CANVAS N-VAS-D 2.0 VASSOL INC. 510(k) NO: K014011(TRADITIONAL) ATTN: LYNETTE L HOWARD PHONE NO : 908-788-4580 203 MAIN STREET, PMB 166 SE DECISION MADE: 05-FEB-02 FLEMINGTON, NJ 08822 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEM VENTLAB CORP. 510(k) NO: K020281(SPECIAL) ATTN: MARGE WALLS-WALKER PHONE NO : 336-492-2636 2934 HWY. 601 NORTH SE DECISION MADE: 11-FEB-02 MOCKSVILLE, NC 27028 510(k) STATEMENT DEVICE: MODIFICATION TO VISTA STEREOSCOPE SYSTEM VISTA MEDICAL TECHNOLOGIES, INC. 510(k) NO: K020301(SPECIAL) ATTN: GRAHAM BAILLIE PHONE NO : 508-366-3668 134 FLANDERS RD. SE DECISION MADE: 12-FEB-02 WESTBOROUGH, MA 01581 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUVUE BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES; CL VISTAKON 510(k) NO: K013973(TRADITIONAL) ATTN: JAMES W PARZIALE PHONE NO : 904-443-1808 7500 CENTURION PARKWAY SE DECISION MADE: 26-FEB-02 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA JACKSONVILLE, FL 32256 DEVICE: UROVYSION BLADDER CANCER RECURRENCE KIT VYSIS 510(k) NO: K013785(ABBREVIATED) ATTN: RUSSEL K ENNS PHONE NO : 630-271-7040 3100 WOODCREEK DR. SE DECISION MADE: 08-FEB-02 DOWNERS GROVE, IL 60515 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LORENZ SELF DRILLING SCREWS WALTER LORENZ SURGICAL, INC. 510(k) NO: K013954(TRADITIONAL) ATTN: KIM REED PHONE NO : 904-741-4400 1520 TRADEPORT DR. SE DECISION MADE: 28-FEB-02 JACKSONVILLE, FL 32218 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LORENZ BLUE DEVICE WALTER LORENZ SURGICAL, INC. 510(k) NO: K020407(SPECIAL) ATTN: KIM REED PHONE NO : 904-741-4400 1520 TRADEPORT DR. SE DECISION MADE: 22-FEB-02 JACKSONVILLE, FL 32218 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO WARTNER WART REMOVAL SYSTEM WARTNER MEDICAL PRODUCTS 510(k) NO: K011708(TRADITIONAL) ATTN: NANCY LUM-WILSON PHONE NO : 905 794 3339 25 BELLINI AVE. SE DECISION MADE: 20-FEB-02 BRAMPTON, ONTARIO, CANADA L6T 3Z8 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WMT MODULAR ULNAR HEAD IMPLANT WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K020274(TRADITIONAL) ATTN: EHAB M ESMAIL PHONE NO : 901-867-4732 5677 AIRLINE RD. SE DECISION MADE: 22-FEB-02 ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DERMGRIP POWDER FREE POLYMER COATED LATEX SURGEON'S GLOVES,STERI WRP SPECIALTY PRODUCTS SDN. BHD. 510(k) NO: K014288(TRADITIONAL) ATTN: MOHD H HUSSEIN PHONE NO : 603 870 69788 LOT11 JALAN2 PERUSAHAAN BANDAR SE DECISION MADE: 13-FEB-02 KAWASAN BARU SALAK TINGGI 510(k) SUMMARY AVAILABLE FROM FDA SEPANG, SELANGOR, MALAYSIA 43900 TOTAL 510(k)s THIS PERIOD 314 TOTAL WITH SUMMARIES 251 TOTAL WITH STATEMENTS 63
Updated 4/28/2004
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