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510(k)s Final Decisions Rendered for June 2000 |
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE) 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD 01-JUN-2000 THROUGH 30-JUN-2000 DEVICE: 3M QUIK TEMP TEMPORIZATION MATERIAL 3M CO. 510(k) NO: K001114(TRADITIONAL) ATTN: CHERI SMOKOVICH PHONE NO : 651-737-9267 3M CENTER BUILDING 26O-2B-12 SE DECISION MADE: 09-JUN-00 ST. PAUL, MN 55144-1000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LASER PHOTOLYSIS SYSTEM, PHARO OPHTHALMIC SURGERY SYSTEM A.R.C. LASER CORP. 510(k) NO: K993154(TRADITIONAL) ATTN: DANIEL HOEFER PHONE NO : 801-972-1311 2417 SOUTH 3850 WEST SE DECISION MADE: 29-JUN-00 SALT LAKE CITY, UT 84120 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AARON 2100 HIGH FREQUENCY ELECTROSURGICAL GENERATOR AARON MEDICAL INDUSTRIES 510(k) NO: K001382(TRADITIONAL) ATTN: RICK KOZLOFF PHONE NO : 727-384-2323 7100 30TH AVE. NORTH SE DECISION MADE: 27-JUN-00 ST. PETERSBURG, FL 33710-2902 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACULUX, MODEL AX3001, AX3002 ACULUX 510(k) NO: K001223(TRADITIONAL) ATTN: KIM MARSH PHONE NO : 941-643-8023 273 SOUTH AIRPORT PULLING RD. SE DECISION MADE: 23-JUN-00 NAPLES, FL 34104 510(k) STATEMENT DEVICE: CITRASATE DIALYSATE ACID CONCENTRATE LIQUID, MODELS CS-1XXX-XX, ADVANCED RENAL TECHNOLOGIES, INC. 510(k) NO: K000792(TRADITIONAL) ATTN: ROBIN CALLAN PHONE NO : 425-825-1276 11838 N.E. 112TH ST. SE DECISION MADE: 08-JUN-00 KIRKLAND, WA 98033 510(k) STATEMENT DEVICE: WINDOW CERVICAL DYNAMIC PLATE SYSTEM ADVANCED SPINE TECHNOLOGY, INC. 510(k) NO: K993066(TRADITIONAL) ATTN: GORDON TAO PHONE NO : 510-251-6798 3645 GRAND AVENUE SE DECISION MADE: 07-JUN-00 SUITE 304 510(k) SUMMARY AVAILABLE FROM FDA OAKLAND, CA 94610 DEVICE: STERRAD 100S STERILIZER ADVANCED STERILIZATION PRODUCTS 510(k) NO: K991999(TRADITIONAL) ATTN: KEVIN CORRIGAN PHONE NO : 949-453-6410 33 TECHNOLOGY DR. SE DECISION MADE: 15-JUN-00 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERRAD BI TEST PACK ADVANCED STERILIZATION PRODUCTS 510(k) NO: K993775(TRADITIONAL) ATTN: KEVIN CORRIGAN PHONE NO : 949-453-6410 33 TECHNOLOGY DR. SE DECISION MADE: 01-JUN-00 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVANTAGE THC TEST ADVANTAGE DIAGNOSTICS CORP. 510(k) NO: K001567(TRADITIONAL) ATTN: JANIS FREESTONE PHONE NO : 650-569-3852 1201 DOUGLAS AVE. SE DECISION MADE: 19-JUN-00 REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPINE SYSTEM EVOLUTION AESCULAP, INC. 510(k) NO: K001080(TRADITIONAL) ATTN: LIA S JONES PHONE NO : 650-876-7000 1000 GATEWAY BOULEVARD SE DECISION MADE: 29-JUN-00 SOUTH SAN FRANCISCO, CA 94080-7030510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LASER SYSTEM MEDIOSTAR H (WITH AND WITHOUT SKIN COOLING SYSTEM) AESCULAP-MEDITEC NORTH AMERICA 510(k) NO: K994116(TRADITIONAL) ATTN: WILLIAM KELLEY PHONE NO : 949-660-2950 2525 MCGAW AVE. SE DECISION MADE: 01-JUN-00 IRVINE, CA 92623-9791 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AGILENT COMPONENT MONITORING SYSTEM; AGILENT INVASIVE BLOOD PRES AGILENT TECHNOLOGIES DEUTSCHLAND G510(k) NO: K001722(SPECIAL) ATTN: EGON PFEIL PHONE NO : 49 703 14647223 HERRENBERGER ST. 130 SE DECISION MADE: 30-JUN-00 D 71034 BOEBLINGEN 510(k) SUMMARY AVAILABLE FROM FDA BOEBLINGEN,, GERMANY DEVICE: AGILENT M2636A TELEMON MONITOR AGILENT TECHNOLOGIES, INC. 510(k) NO: K001436(SPECIAL) ATTN: DENISE HALEY PHONE NO : 978-659-2701 3000 MINUTEMAN RD. SE DECISION MADE: 07-JUN-00 ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPACT PORTABLE PATIENT MONITOR WITH WIRELESS ALAN, MODEL ALILE AGILENT TECHNOLOGIES, INC. 510(k) NO: K001664(SPECIAL) ATTN: DAVE OSBORN PHONE NO : 978-659-3178 3000 MINUTEMAN RD. SE DECISION MADE: 30-JUN-00 ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: M2410B IMAGEPOINT HX MULTISPECIALTY SYSTEM, VERSION B.1 AGILENT TECHNOLOGIES, INC. 510(k) NO: K001711(TRADITIONAL) ATTN: STEVE SINGLAR PHONE NO : 978-659-2101 3000 MINUTEMAN RD. SE DECISION MADE: 20-JUN-00 ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO HP M2376A DEVICE LINK SYSTEM, MODEL M2376A AGILENT TECHNOLOGIES, INC. 510(k) NO: K001776(SPECIAL) ATTN: MIKE HUDSON PHONE NO : 978-685-3173 3000 MINUTEMAN RD., MS 0491 SE DECISION MADE: 30-JUN-00 ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AIRDENT II CS AIR TECHNOLOGIES, INC. 510(k) NO: K001313(TRADITIONAL) ATTN: JOSEPH CAREY PHONE NO : 516-433-7676 70 CANTIAGUE ROCK RD SE DECISION MADE: 08-JUN-00 HICKSVILLE, NY 11802 510(k) STATEMENT DEVICE: MONARCH II IOL DELIVERY SYSTEM ALCON RESEARCH, LTD. 510(k) NO: K001157(TRADITIONAL) ATTN: SHERRI J LAKOTA PHONE NO : 817-568-6179 6201 SOUTH FREEWAY SE DECISION MADE: 27-JUN-00 FORT WORTH, TX 76134-2099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSTANT-VIEW MARIJUANA URINE CASSETTE TEST ALFA SCIENTIFIC DESIGNS, INC. 510(k) NO: K994405(TRADITIONAL) ATTN: NAISHU WANG PHONE NO : 858-350-9798 11494 SORRENTO VALLEY RD., SE DECISION MADE: 02-JUN-00 SUITE F/M 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92121 DEVICE: INSTANT-VIEW MARIJUANA (THC) URINE DIP STRIP TEST ALFA SCIENTIFIC DESIGNS, INC. 510(k) NO: K994410(TRADITIONAL) ATTN: NAISHU WANG PHONE NO : 858-350-9798 11494 SORRENTO VALLEY RD., SE DECISION MADE: 21-JUN-00 SUITE F/M 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92121 DEVICE: CALIBRATION SOLUTION 1, MODEL A943-837; CALIBRATION SOLUTION 2, ALKO DIAGNOSTIC CORP. 510(k) NO: K001484(TRADITIONAL) ATTN: PATRICK CHIU PHONE NO : 508-429-4600 333 FISKE STREET SE DECISION MADE: 19-JUN-00 HOLLISTON, MA 01746-2048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLEXAM NITRILE T AMBI EXAMINATION GLOVES WITH CHEMO CLAIM ALLEGIANCE HEALTHCARE COPORATION 510(k) NO: K000813(TRADITIONAL) ATTN: ERICA SETHI PHONE NO : 847-785-3337 1500 WAUKERGAN ROAD SE DECISION MADE: 08-JUN-00 BUILDING WM 510(k) SUMMARY AVAILABLE FROM FDA MCGAW PARK, IL 60085 DEVICE: RESOLVE SURGICAL O.R. TOWELS ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K001667(TRADITIONAL) ATTN: SHARON ROBBINS PHONE NO : 847-785-3311 1500 WAUKEGAN RD., MPWM SE DECISION MADE: 23-JUN-00 MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GEMINI E ALLEN MEDICAL INSTRUMENTS CORP. 510(k) NO: K993623(TRADITIONAL) ATTN: JUDITH ALLEN PHONE NO : 949-646-3215 505 SUPERIOR AVE. SE DECISION MADE: 23-JUN-00 NEWPORT BEACH, CA 92663 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPLETE BRAND COMFORTPLUS MULTI-PURPOSE SOLUTION ALLERGAN, INC. 510(k) NO: K000164(TRADITIONAL) ATTN: PAUL J NOWACKI PHONE NO : 714-246-6761 2525 DUPONT DR. SE DECISION MADE: 02-JUN-00 IRVINE, CA 92612 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DBEST HCG 2 IU/ML TEST KIT AMERITEK, INC. 510(k) NO: K001215(ABBREVIATED) ATTN: K.C. YEE PHONE NO : 206-527-5086 7030 35TH AVE., N.E. SE DECISION MADE: 22-JUN-00 SEATTLE, WA 98115 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DR9000 DIGITAL RADIOGRAPHY X-RAY SYSTEM ANALOGIC CORP. 510(k) NO: K001336(TRADITIONAL) ATTN: ROBERT H FRENCH PHONE NO : 978-977-3000 8 CENTENNIAL DR. SE DECISION MADE: 02-JUN-00 PEABODY, MA 01960 510(k) STATEMENT DEVICE: DR5000 DEDICATED CHEST X-RAY SYSTEM ANALOGIC CORP. 510(k) NO: K001341(TRADITIONAL) ATTN: ROBERT H FRENCH PHONE NO : 978-977-3000 8 CENTENNIAL DR. SE DECISION MADE: 02-JUN-00 PEABODY, MA 01960 510(k) STATEMENT DEVICE: BESTNEB PORTABLE AEROSOL THERAPY UNIT, AP-100100 APEX MEDICAL CORP. 510(k) NO: K990435(TRADITIONAL) ATTN: DANIEL LEE PHONE NO : 886 269 54170 10TH FL., NO. 31, LANE 169, SE DECISION MADE: 05-JUN-00 KANG NING ST. 510(k) STATEMENT HSI CHIH CHEN, TAIPEI HSIEN, CHINA (TAIWAN) DEVICE: AUDIO TECHNOLOGIES S:R.1 AUDIO TECHNOLOGIES S.R.L. 510(k) NO: K001142(TRADITIONAL) ATTN: FRANCO BEONI PHONE NO : 390 523 778864 VIA DELL'ARTIGINATO, 8 SE DECISION MADE: 23-JUN-00 GOSSOLENGO, ITALY 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AURELUX Y 84 PREMIUM AUREX SA (PTY) LTD. 510(k) NO: K001477(TRADITIONAL) ATTN: J. D DAVIS PHONE NO : 11 609 8640 24 PLANTATION ROAD, EASTLEIGH SE DECISION MADE: 20-JUN-00 EDENVALE, GAUTENG, SOUTH AFRICA 16510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AURECAST SUPER INLAY AUREX SA (PTY) LTD. 510(k) NO: K001478(TRADITIONAL) ATTN: J. D DAVIS PHONE NO : 11 609 8640 24 PLANTATION ROAD, EASTLEIGH SE DECISION MADE: 20-JUN-00 EDENVALE, GAUTENG, SOUTH AFRICA 16510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PALCERAM 53 AUREX SA (PTY) LTD. 510(k) NO: K001479(TRADITIONAL) ATTN: J. D DAVIS PHONE NO : 11 609 8640 24 PLANTATION ROAD, EASTLEIGH SE DECISION MADE: 21-JUN-00 EDENVALE, GAUTENG, SOUTH AFRICA 16510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AURECAST 40 B AUREX SA (PTY) LTD. 510(k) NO: K001480(TRADITIONAL) ATTN: J. D DAVIS PHONE NO : 11 609 8640 24 PLANTATION ROAD, EASTLEIGH SE DECISION MADE: 21-JUN-00 EDENVALE, GAUTENG, SOUTH AFRICA 16510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PALCERAM 49 AUREX SA (PTY) LTD. 510(k) NO: K001481(TRADITIONAL) ATTN: J. D DAVIS PHONE NO : 11 609 8640 24 PLANTATION ROAD, EASTLEIGH SE DECISION MADE: 23-JUN-00 EDENVALE, GAUTENG, SOUTH AFRICA 16510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AURENORM 75 KF AUREX SA (PTY) LTD. 510(k) NO: K001482(TRADITIONAL) ATTN: J. D DAVIS PHONE NO : 11 609 8640 24 PLANTATION ROAD, EASTLEIGH SE DECISION MADE: 23-JUN-00 EDENVALE, GAUTENG, SOUTH AFRICA 16510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009 AVL SCIENTIFIC CORP. 510(k) NO: K001632(TRADITIONAL) ATTN: RANDY BYRD PHONE NO : 770-576-5000 235 HEMBREE PARK DR. SE DECISION MADE: 19-JUN-00 ROSWELL, GA 30076 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRASTIM ELECTRODE, MODEL US4040 AXELGAARD MFG. CO., LTD. 510(k) NO: K000947(TRADITIONAL) ATTN: DAN JEFFERY PHONE NO : 760-723-7554 329 WEST AVIATION RD. SE DECISION MADE: 16-JUN-00 FALLBROOK, CA 92028-3227 510(k) STATEMENT DEVICE: DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600 AXIS-SHIELD 510(k) NO: K001574(TRADITIONAL) ATTN: EILEEN A MCCAFFERTY PHONE NO : 44 138 2422000 THE TECHNOLOGY PARK SE DECISION MADE: 09-JUN-00 DUNDEE, SCOTLAND, UNITED KINGDOM D510(k) STATEMENT DEVICE: PSN HEMODIALYZER, MODELS PSN 170, PSN 210 BAXTER HEALTHCARE CORP. 510(k) NO: K001422(SPECIAL) ATTN: ROBERT L WILKINSON PHONE NO : 847-473-6335 1620 WAUKEGAN ROAD SE DECISION MADE: 02-JUN-00 MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITH BAXTER HEALTHCARE CORP. 510(k) NO: K992532(TRADITIONAL) ATTN: JASON SMITH PHONE NO : 949-250-2662 17221 RED HILL AVENUE (IRVINE) SE DECISION MADE: 13-JUN-00 P.O. BOX 11150 510(k) SUMMARY AVAILABLE FROM FDA SANTA ANA,, CA 92711-1150 DEVICE: ADVIA IMS BAYER CORP. 510(k) NO: K001344(TRADITIONAL) ATTN: FREDRICK CLERIE PHONE NO : 914-524-2954 511 BENEDICT AVE. SE DECISION MADE: 26-JUN-00 TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST BEACON BIOLOGICALS, INC. 510(k) NO: K000687(TRADITIONAL) ATTN: KANTI DAYA PHONE NO : 561-394-7825 6004 GLENDALE DRIVE SE DECISION MADE: 12-JUN-00 BOCA RATON, FL 33433 510(k) STATEMENT DEVICE: SYNCHRON CONTROL BECKMAN COULTER, INC. 510(k) NO: K001458(SPECIAL) ATTN: LUCINDA STOCKERT PHONE NO : 714-961-3777 200 S. KRAEMER BLVD.,M/S W-104 SE DECISION MADE: 02-JUN-00 BOX 8000 510(k) SUMMARY AVAILABLE FROM FDA BREA, CA 92822-8000 DEVICE: BD DIRECTIGEN FLU A+B BECTON DICKINSON & CO. 510(k) NO: K001364(TRADITIONAL) ATTN: MONICA GIGUERE PHONE NO : 410-316-4287 7 LOVETON CIRCLE SE DECISION MADE: 28-JUN-00 SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLICKER BIOJECT, INC. 510(k) NO: K994384(TRADITIONAL) ATTN: NANCY GERTLAR PHONE NO : 800-683-7221 7620 S.W. BRIDGEPORT RD. SE DECISION MADE: 22-JUN-00 PORTLAND, OR 97224 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEMOGRAPH; OSSTAPLE - ORAL AND MAXILLIOFACIAL PROCEDURES FOR THE BIOMEDICAL ENT., INC. 510(k) NO: K001219(TRADITIONAL) ATTN: W. CASEY FOX PHONE NO : 210-677-0354 14785 OMICRON DR. SE DECISION MADE: 21-JUN-00 SUITE 205 510(k) SUMMARY AVAILABLE FROM FDA SAN ANTONIO, TX 78245-3201 DEVICE: MALLORY HEAD MODULAR CALCAR BIOMET ORTHOPEDICS, INC. 510(k) NO: K001660(SPECIAL) ATTN: MICHELLE L MCKINLEY PHONE NO : 219-372-1644 56 EAST BELL DRIVE SE DECISION MADE: 14-JUN-00 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFIED SINGLE AXLE TOTAL ELBOW BIOMET, INC. 510(k) NO: K000683(SPECIAL) ATTN: FRED MCCLURE PHONE NO : 219-372-1568 AIRPORT INDUSTRIAL PARK SE DECISION MADE: 27-JUN-00 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46580 DEVICE: ANATOMIC TOTAL KNEE PROSTHESIS BIOMET, INC. 510(k) NO: K000978(TRADITIONAL) ATTN: LONNIE WITHAM PHONE NO : 219-372-1510 AIRPORT INDUSTRIAL PARK SE DECISION MADE: 22-JUN-00 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46580 DEVICE: BIOSORBPDX BIOABSORBABLE FIXATION SYSTEM BIONX IMPLANTS, INC. 510(k) NO: K000836(TRADITIONAL) ATTN: TUIJA ANNALA PHONE NO : 358 331 65600 HERMIANKATU 6-8 L SE DECISION MADE: 08-JUN-00 TAMPERE, FINLAND FIN-33720Y 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOPRO GLENOID COMPONENT W/ KEEL & W/ POSTS BIOPRO, INC. 510(k) NO: K001046(TRADITIONAL) ATTN: CHERYL WARSINSKE PHONE NO : 810-987-7777 17 SEVENTEENTH ST. SE DECISION MADE: 08-JUN-00 PORT HURON, MI 48060 510(k) STATEMENT DEVICE: BIOSOFT RESIN BIOSOFT INTERNATIONAL COPR. 510(k) NO: K001640(TRADITIONAL) ATTN: ROY SHU PHONE NO : 609-393-0488 944 WILLIAMS STREET SE DECISION MADE: 23-JUN-00 TRENTON, NJ 08610 510(k) STATEMENT DEVICE: AU5 ULTRASOUND IMAGING SYSTEM BIOSOUND ESAOTE, INC. 510(k) NO: K000931(TRADITIONAL) ATTN: COLLEEN HITTLE PHONE NO : 317-849-1793 8000 CASTLEWAY DRIVE SE DECISION MADE: 08-JUN-00 INDIANAPOLIS, IN 46350 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL BIOTRONIK, INC. 510(k) NO: K001413(SPECIAL) ATTN: JON BRUMBAUGH PHONE NO : 888-345-0374 6024 SOUTHWEST JEAN ROAD SE DECISION MADE: 02-JUN-00 LAKE OSWEGO, OR 97035-5369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BONASSE CONTACT LENS CASE BONASSE ENT. CO., LTD. 510(k) NO: K991206(TRADITIONAL) ATTN: MILTON N BENEKE PHONE NO : 843-215-6950 55 NORTHERN BLVD. SE DECISION MADE: 06-JUN-00 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TALON BALLOON DILATION CATHETER BOSTON SCIENTIFIC CORP. 510(k) NO: K000798(TRADITIONAL) ATTN: TERRY A MCGOVERN PHONE NO : 508-652-5439 ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 08-JUN-00 NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY S BOSTON SCIENTIFIC SCIMED, INC. 510(k) NO: K000001(TRADITIONAL) ATTN: RON BENNETT PHONE NO : 612-694-5642 5905 NATHAN LANE SE DECISION MADE: 05-JUN-00 MINNEAPOLIS, MN 55442 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VASO PRESS DVT SYSTEM, MODELS VP500, VP501 BRITT CORP., INC. 510(k) NO: K991038(TRADITIONAL) ATTN: J. JAMES BRITTON PHONE NO : 732-817-1122 16 CREST DR. SE DECISION MADE: 22-JUN-00 COLTS NECK, NJ 07722 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PENADAPT 10 BUFFALO FILTER CO., INC. 510(k) NO: K000904(TRADITIONAL) ATTN: KATHLEEN H SELOVER PHONE NO : 800-343-2324 595 COMMERCE DRIVE SE DECISION MADE: 08-JUN-00 BUFFALO, NY 14228 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODEL APS ALTERNANS PROCESSING SYSTEM CAMBRIDGE HEART, INC. 510(k) NO: K001034(SPECIAL) ATTN: JOHN GREENBAUM PHONE NO : 954-680-2548 20310 SW 48TH ST. SE DECISION MADE: 09-JUN-00 FT. LAUDERDALE, FL 33332 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CANON LASER BLOOD FLOWMETER (CLBF) MODEL 100 CANON U.S.A. INC. 510(k) NO: K992606(TRADITIONAL) ATTN: KEN SHADOFF PHONE NO : 516-328-5602 ONE CANON PLAZA SE DECISION MADE: 21-JUN-00 LAKE SUCCESS, NY 11042-1113 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRITERION 60 OR PM 60 CARADYNE, LTD. 510(k) NO: K000959(ABBREVIATED) ATTN: PAUL DRYDEN PHONE NO : 317-335-3780 6329 W. WATERVIEW CT. SE DECISION MADE: 22-JUN-00 MCCORDSVILLE, IN 46055 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501; BIOZ.PC USER SO CARDIODYNAMICS INTERNATIONAL CORP.510(k) NO: K001081(TRADITIONAL) ATTN: BRIAN PARK PHONE NO : 858-535-0202 6175 NANCY RIDGE DR., #300 SE DECISION MADE: 30-JUN-00 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CERAMIX EZ CAST, CERAMIX EZ CAST SOLDER, CERAMIX EZ CAST FLUX CERAMIX CORPORATION 510(k) NO: K000981(TRADITIONAL) ATTN: ART WARD PHONE NO : 813-645-2855 3234 ELLA LANE SE DECISION MADE: 13-JUN-00 NEW PORT RICHEY, FL 34655 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHAD THERAPEUTICS OXYMATIC MODEL 401 CHAD THERAPEUTICS, INC. 510(k) NO: K000890(TRADITIONAL) ATTN: OSCAR J SANCHEZ PHONE NO : 818-882-0883 21622 PLUMMER ST. SE DECISION MADE: 16-JUN-00 CHATSWORTH, CA 91311 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO STATSIGN SALINE ELECTROLYTE GEL, GRAHAM-FIELD SA CHESTER LABS, INC. 510(k) NO: K001593(SPECIAL) ATTN: HOLLY SHERWOOD PHONE NO : 513-458-3840 1900 SECTION RD., SUITE A SE DECISION MADE: 14-JUN-00 CINCINNATI, OH 45237 510(k) STATEMENT DEVICE: STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE COND CHESTER LABS, INC. 510(k) NO: K001705(SPECIAL) ATTN: HOLLY SHERWOOD PHONE NO : 513-458-3840 1900 SECTION RD., SUITE A SE DECISION MADE: 29-JUN-00 CINCINNATI, OH 45237 510(k) STATEMENT DEVICE: STOCKERT V142 SERIES VENOUS CANNULAE WITH LIGHTHOUSE TIP COBE CARDIOVASCULAR, INC. 510(k) NO: K994209(ABBREVIATED) ATTN: LYNNE LEONARD PHONE NO : 303-467-6586 14401 WEST 65TH WAY SE DECISION MADE: 14-JUN-00 ARVADA, CO 80004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONMED TROGARD FINESSE TROCAR SYSTEM, MODEL 60-6050-XXX CONMED CORP. 510(k) NO: K001597(SPECIAL) ATTN: IRA D DUESLER, JR. PHONE NO : 315-797-8375 310 BROAD ST. SE DECISION MADE: 05-JUN-00 UTICA, NY 13501-1203 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYFRECATOR 2000 REUSABLE HAND-SWITCHING ACCESSORY HANDPIECE/FOOT CONMEDCORP 510(k) NO: K001159(TRADITIONAL) ATTN: CHARLES M (MIKE) HART PHONE NO : 303-699-7600 14603 E. FREMONT AVE. SE DECISION MADE: 07-JUN-00 ENGLEWOOD, CO 80112 510(k) STATEMENT DEVICE: ULTRAPEN REUSABLE PENCIL, MODEL 130350 THROUGH 130353, REUSABLE CONMEDCORP 510(k) NO: K001161(TRADITIONAL) ATTN: CHARLES M (MIKE) HART PHONE NO : 303-699-7600 14603 E. FREMONT AVE. SE DECISION MADE: 07-JUN-00 ENGLEWOOD, CO 80112 510(k) STATEMENT DEVICE: CONTEMPRO-MIST CONTEMPORARY PRODUCTS, INC. 510(k) NO: K000543(TRADITIONAL) ATTN: BARRY A SCHWARTZ PHONE NO : 207-797-4647 530 RIVERSIDE INDUSTRIAL PKWY. SE DECISION MADE: 16-JUN-00 PORTLAND, ME 04103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OCD2001 CONTEMPORARY PRODUCTS, INC. 510(k) NO: K992935(ABBREVIATED) ATTN: BARRY A SCHWARTZ PHONE NO : 207-797-4647 530 RIVERSIDE INDUSTRIAL PKWY. SE DECISION MADE: 20-JUN-00 PORTLAND, ME 04103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BX TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM CORDIS CORP. 510(k) NO: K001258(SPECIAL) ATTN: DEAN A KNIGHT PHONE NO : 908-412-7135 7 POWDERHORN DRIVE SE DECISION MADE: 27-JUN-00 WARREN, NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERFORMER 30 HPS CORNELIA DAMSKY, INC. 510(k) NO: K001322(TRADITIONAL) ATTN: CORNELIA DAMSKY PHONE NO : 203-323-7535 56 WESTCOTT ROAD SE DECISION MADE: 30-JUN-00 STAMFORD, CT 06902 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLYESTER NONABSORBABLE SURGICAL SUTURES URP CP MEDICAL 510(k) NO: K001172(TRADITIONAL) ATTN: PATRICK FERGUSON PHONE NO : 503-232-1555 836 N.E. 24TH AVE. SE DECISION MADE: 23-JUN-00 PORTLAND, OR 97232 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NYLON, NONABSORBABLE SURGICAL SUTURES USP CP MEDICAL 510(k) NO: K001173(TRADITIONAL) ATTN: PATRICK FERGUSON PHONE NO : 503-232-1555 836 N.E. 24TH AVE. SE DECISION MADE: 23-JUN-00 PORTLAND, OR 97232 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SILK, NONABSORBABLE, SURGICAL SUTURES, USP CP MEDICAL 510(k) NO: K001184(TRADITIONAL) ATTN: PATRICK FERGUSON PHONE NO : 503-232-1555 836 N.E. 24TH AVE. SE DECISION MADE: 23-JUN-00 PORTLAND, OR 97232 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLYPROPYLENE, NONABSORBABLE SURGICAL SUTURES USP CP MEDICAL 510(k) NO: K001185(TRADITIONAL) ATTN: PATRICK FERGUSON PHONE NO : 503-232-1555 836 N.E. 24TH AVE. SE DECISION MADE: 23-JUN-00 PORTLAND, OR 97232 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USP CP MEDICAL 510(k) NO: K001299(TRADITIONAL) ATTN: PATRICK FERGUSON PHONE NO : 503-232-1555 836 N.E. 24TH AVE. SE DECISION MADE: 23-JUN-00 PORTLAND, OR 97232 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C.S.O. TONOMETER CSO 510(k) NO: K992835(TRADITIONAL) ATTN: R. BRENT MINER PHONE NO : 716-632-1988 197 BELVOIR ROAD SE DECISION MADE: 06-JUN-00 WILLIAMSVILLE, NY 14221 510(k) STATEMENT DEVICE: VARIOUS STERILE AND NON-STERILE SURGICAL DRAPES, (I.E., DISPOSAB CUSTOM MEDICAL PRODUCTS, INC. 510(k) NO: K994199(TRADITIONAL) ATTN: STEVE WOODY PHONE NO : 828-281-2109 1 HOLIDAY INN DRIVE SE DECISION MADE: 09-JUN-00 BUILDING E 510(k) STATEMENT ASHEVILLE, NC 28806 DEVICE: EHC 400 DESKTOP PATIENT STATION, EHC 600 CORE PROVIDER STATION CYBERCARE, INC. 510(k) NO: K000237(TRADITIONAL) ATTN: RICHARD HALBACH PHONE NO : 770-352-9540 7840 ROSWELL RD. SE DECISION MADE: 13-JUN-00 SUITE 320 510(k) SUMMARY AVAILABLE FROM FDA ATLANTA, GA 30350 DEVICE: CYNOSURE APOGEE-TKS DERMATOLOGICAL LASER CYNOSURE, INC. 510(k) NO: K992757(TRADITIONAL) ATTN: GEORGE CHO PHONE NO : 978-256-4200 10 ELIZABETH DR. SE DECISION MADE: 29-JUN-00 CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BEHRING COAGULATION TIMER ANALYZER (BCT) DADE BEHRING, INC. 510(k) NO: K001064(TRADITIONAL) ATTN: REBECCA S AYASH PHONE NO : 302-631-6276 GLASGOW SITE SE DECISION MADE: 21-JUN-00 P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: DADE BEHRING COAGULATION ANALYZER (BCT) DADE BEHRING, INC. 510(k) NO: K001067(TRADITIONAL) ATTN: REBECCA S AYASH PHONE NO : 302-631-6276 GLASGOW SITE SE DECISION MADE: 20-JUN-00 P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: "UNICORN" MODEL SYS0630 DANISH DIAGNOSTIC DEVELOPMENT A/S 510(k) NO: K001888(ABBREVIATED) ATTN: NEERGAARDSVEJ 5F PHONE NO : 45 45 768888 SE DECISION MADE: 30-JUN-00 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AS/3 ANESTHESIA MONTIOR WITH S-ANE99(A)/L-ARK99(A) DATEX-OHMEDA 510(k) NO: K000815(TRADITIONAL) ATTN: JOEL C KENT PHONE NO : 978-640-0460 THREE HIGHWOOD DRIVE SE DECISION MADE: 08-JUN-00 TEWKSBURY, MA 01876 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DATEX-OHMEDA CS/3 TELEMETRY SYSTEM DATEX-OHMEDA 510(k) NO: K000882(TRADITIONAL) ATTN: JOEL KENT PHONE NO : 978-640-0460 THREE HIGHWOOD DRIVE SE DECISION MADE: 05-JUN-00 TEWKSBURY, MA 01876 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DATEX-OHMEDA EEG MODULE, M-EEG AND DATEX-OHMEDA EEG HEADBOX, N-E DATEX-OHMEDA, INC. 510(k) NO: K000892(TRADITIONAL) ATTN: JOEL KENT PHONE NO : 978-640-0460 3 HIGHWOOD DR. SE DECISION MADE: 16-JUN-00 TEWKSBURY, MA 01876 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER DATEX-OHMEDA, INC. 510(k) NO: K001688(SPECIAL) ATTN: DALE THANIG PHONE NO : 303-673-1367 1315 WEST CENTURY DR. SE DECISION MADE: 30-JUN-00 LOUISVILLE, CO 80027 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCHOTTLANDER ENIGMA COLOUR TONE, MODEL 0156 DAVIS SCHOTTLANDER & DAVIS, LTD. 510(k) NO: K001463(TRADITIONAL) ATTN: CLARK SMITH PHONE NO : 816-868-8711 124 E. MISSOURI AVE. SE DECISION MADE: 16-JUN-00 KANSAS CITY, MO 64106 510(k) STATEMENT DEVICE: DENTALMATIC TI PROSTHESIS AND DENTALMATIC TI-A PROSTHETIC DENTALMATIC TECHNOLOGIES, INC 510(k) NO: K001269(TRADITIONAL) ATTN: NAOUM ARAJ PHONE NO : 514 337 1444 9710 TRANSCANADA HIGHWAY ST SE DECISION MADE: 21-JUN-00 ST LAURENT, QC, CANADA H4S 1V9 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND DENTSPLY INTL. 510(k) NO: K000996(TRADITIONAL) ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511 570 WEST COLLEGE AVE SE DECISION MADE: 16-JUN-00 YORK, PA 17404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PINNACLE ACETABULAR SYSTEM DEPUY ORTHOPAEDICS, INC. 510(k) NO: K001534(SPECIAL) ATTN: LYNNETTE WHITAKER PHONE NO : 219-371-4903 700 ORTHOPAEDIC DRIVE SE DECISION MADE: 12-JUN-00 P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0988 DEVICE: TRIFLANGE ACETABULAR CUP SYSTEM DEPUY ORTHOPAEDICS, INC. 510(k) NO: K001277(TRADITIONAL) ATTN: MARCIA J ARENTZ PHONE NO : 219-371-4944 700 ORTHOPAEDIC DR. SE DECISION MADE: 23-JUN-00 WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30 DIAGNOSTIC CHEMICALS LTD. 510(k) NO: K001285(TRADITIONAL) ATTN: KAREN CALLBECK PHONE NO : 902 566 1396 16 MCCARVILLE STREET SE DECISION MADE: 02-JUN-00 CHARLOTTETOWN, CANADA C1E 2A6 510(k) STATEMENT DEVICE: ETHANOL-L3K ASSAY, MODELS 273-30, 273-17, 273-10 DIAGNOSTIC CHEMICALS LTD. 510(k) NO: K001286(TRADITIONAL) ATTN: KAREN CALLBECK PHONE NO : 902 566 1396 16 MCCARVILLE STREET SE DECISION MADE: 20-JUN-00 CHARLOTTETOWN, CANADA C1E 2A6 510(k) STATEMENT DEVICE: IMMULITE H. PYLORI IGG AND IMMULITE 2000 H. PYLORI IGG DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K000463(TRADITIONAL) ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200 5700 WEST 96TH ST. SE DECISION MADE: 01-JUN-00 LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIDECO LILLIPUT 1 TWIN RESERVOIR WITH PHOSPHORILCHOLINE INSERT S DIDECO S.P.A. 510(k) NO: K001602(SPECIAL) ATTN: BARRY SALL PHONE NO : 781-434-4742 195 WEST STREET SE DECISION MADE: 08-JUN-00 WALTHAM, MA 02451-1163 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM DISETRONIC MEDICAL SYSTEMS AG 510(k) NO: K001629(SPECIAL) ATTN: LEE LEICHTER PHONE NO : 941-761-1118 7690 CAMERON CIRCLE SE DECISION MADE: 21-JUN-00 FORT MYERS, FL 33912 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CIPA (ADULTS) CIPI (INFANTS) DMC MEDICAL LTD. 510(k) NO: K992932(TRADITIONAL) ATTN: CHARMAINE HENDERSON PHONE NO : 714-525-8441 511 CATALINA ROAD SE DECISION MADE: 07-JUN-00 FULLERTON, CA 92835 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DORNIER MEDILAS D SKINPULSE DORNIER SURGICAL PRODUCTS, INC. 510(k) NO: K000072(TRADITIONAL) ATTN: SUSANNE COURTNEY PHONE NO : 770-693-5793 10027 SOUTH 51ST ST. SE DECISION MADE: 12-JUN-00 PHOENIX, AZ 85044-6731 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NARKOMED MRI , NM-MRI DRAEGER MEDICAL, INC. 510(k) NO: K001488(SPECIAL) ATTN: J TERESA DORREITY, JD PHONE NO : 215-721-5400 3135 QUARRY RD. SE DECISION MADE: 09-JUN-00 TELFORD, PA 18969 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRI-FIX SPINAL FIXATION SYSTEM ENDIUS INC. 510(k) NO: K000766(TRADITIONAL) ATTN: SUSAN FINNERAN PHONE NO : 508-643-0983 23 WEST BACON ST. SE DECISION MADE: 01-JUN-00 PLAINVILLE, MA 02762 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIFIX SPINAL FIXATION SYSTEM ENDIUS INC. 510(k) NO: K001627(SPECIAL) ATTN: SUSAN FINNERAN PHONE NO : 508-643-0983 23 WEST BACON ST. SE DECISION MADE: 03-JUN-00 PLAINVILLE, MA 02762 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENSITE 3000 SYSTEM, MODEL EE3000 ENDOCARDIAL SOLUTIONS, INC. 510(k) NO: K001437(SPECIAL) ATTN: ERIC KOEHLER PHONE NO : 651-523-6934 1350 ENERGY LN., SUITE 110 SE DECISION MADE: 07-JUN-00 ST. PAUL, MN 55108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVANAR F/X 2.9F INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL ENDOSONICS CORP. 510(k) NO: K000820(SPECIAL) ATTN: CHRISTINA KICHULA PHONE NO : 301-424-9700 1401 ROCKVILLE PIKE SE DECISION MADE: 05-JUN-00 SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA ROCKVILLE, MD 20850 DEVICE: STAT-SHELL DISPOSABLE SP02 SENSOR EPIC MEDICAL EQUIPMENT SERVICES IN510(k) NO: K000831(TRADITIONAL) ATTN: KRISTA OAKES PHONE NO : 972-801-9854 1800 10TH ST., SUITE 300 SE DECISION MADE: 05-JUN-00 PLANO, TX 75074 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4 EXCEL TECH. LTD. 510(k) NO: K001101(TRADITIONAL) ATTN: DEBBIE DAVY PHONE NO : 905 829 5300 2568 BRISTOL CIRCLE SE DECISION MADE: 30-JUN-00 OAKVILLE, ONTARIO, CANADA L6H 5S1510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS (PROPOSED) EXCEL TECH. LTD. 510(k) NO: K001103(TRADITIONAL) ATTN: DEBBIE DAVY PHONE NO : 905 829 5300 2568 BRISTOL CIRCLE SE DECISION MADE: 30-JUN-00 OAKVILLE, ONTARIO, CANADA L6H 5S1510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K000702(TRADITIONAL) ATTN: ARTHUR EILINSFELD PHONE NO : 800-662-1237 TWO LEDGEMONT CENTER SE DECISION MADE: 07-JUN-00 95 HAYDEN AVENUE 510(k) SUMMARY AVAILABLE FROM FDA LEXINGTON, MA 02420 DEVICE: FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-229 FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K001107(TRADITIONAL) ATTN: ARTHUR EILINSFELD PHONE NO : 781-402-9068 95 HAYDEN AVE. SE DECISION MADE: 23-JUN-00 TWO LEDGEMONT CENTER 510(k) SUMMARY AVAILABLE FROM FDA LEXINGTON, MA 02420-9192 DEVICE: GE MARQUETTE CLINICAL INFORMATION CENTER, GE MARQUETTE CIC GE MARQUETTE MEDICAL SYSTEMS, INC.510(k) NO: K001112(TRADITIONAL) ATTN: DAVID WAHLIG PHONE NO : 414-362-2090 8200 WEST TOWER AVE. SE DECISION MADE: 14-JUN-00 MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAC-LAB SYSTEM AND CARDIOLAB EP SYSTEM GE MARQUETTE MEDICAL SYSTEMS, INC.510(k) NO: K001305(TRADITIONAL) ATTN: J. LAN MCDONALD PHONE NO : 281-275-5109 13000 EXECUTIVE DR. SE DECISION MADE: 27-JUN-00 SUGAR LAND, TX 77478 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSUFFLATION NEEDLE- 120MM, MODEL 900-200 GENICON, LC 510(k) NO: K993625(TRADITIONAL) ATTN: GARY HABERLAND PHONE NO : 407-273-7619 573 WATERSCAPE WAY SE DECISION MADE: 20-JUN-00 ORLANDO, FL 32828 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENYX FLEXIBLE INJECTION NEEEDLE GENY MEDICAL INC. 510(k) NO: K001146(TRADITIONAL) ATTN: JUDY F GORDON PHONE NO : 949-454-4177 66 ARGONAUT # 170 SE DECISION MADE: 30-JUN-00 ALISO VIEJO, CA 92656 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 'COTTONY' II DACRON, "SILKY" II POLYDEK & TEVDEK II POLYESTER NO GENZYME SURGICAL PRODUCTS CORP. 510(k) NO: K001434(TRADITIONAL) ATTN: MARY E GRAY PHONE NO : 508-677-6512 600 AIRPORT ROAD SE DECISION MADE: 12-JUN-00 FALL RIVER, MA 02720-4740 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIKING OPTIMA GUIDING CATHETER GUIDANT CORP. 510(k) NO: K001435(SPECIAL) ATTN: STACEY SIMON PHONE NO : 909-914-4527 26531 YNEZ RD. SE DECISION MADE: 02-JUN-00 TEMECULA, CA 92591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GALILEO VENTILATOR HAMILTON MEDICAL, INC. 510(k) NO: K001686(ABBREVIATED) ATTN: J. DAVID THOMPSON PHONE NO : 775-858-3200 505 EDISON WAY SE DECISION MADE: 23-JUN-00 P.O. BOX 30008 510(k) STATEMENT RENO, NV 89520 DEVICE: HANWELLA LATEX PATIENT EXAM. GLOVES POWDER-FREE HANWELLA RUBBER PRODUCTS LTD. 510(k) NO: K000351(TRADITIONAL) ATTN: B. DAMITHA P DHARMASENA PHONE NO : 94 74 796936 46/34 NAVAM MAWATHA, SE DECISION MADE: 23-JUN-00 COLOMBO 2, SRI LANKA 510(k) STATEMENT DEVICE: HARDYDISK CINOXACIN, 100 MCG HARDY DIAGNOSTICS 510(k) NO: K001487(TRADITIONAL) ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766 1430 WEST MCCOY LANE SE DECISION MADE: 07-JUN-00 SANTA MARIA, CA 93455 510(k) STATEMENT DEVICE: HARDYDISK CEFOPERAZONE, 75 MCG HARDY DIAGNOSTICS 510(k) NO: K001489(TRADITIONAL) ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766 1430 WEST MCCOY LANE SE DECISION MADE: 01-JUN-00 SANTA MARIA, CA 93455 510(k) STATEMENT DEVICE: HARDYDISK CEFONICID, 30 MCG HARDY DIAGNOSTICS 510(k) NO: K001490(TRADITIONAL) ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766 1430 WEST MCCOY LANE SE DECISION MADE: 01-JUN-00 SANTA MARIA, CA 93455 510(k) STATEMENT DEVICE: HARVEST TECHNOLOGIES DUAL LIQUID APPLICATOR, MODEL SK/S: HARVES HARVEST TECHNOLOGIES, LLC 510(k) NO: K000456(TRADITIONAL) ATTN: ANNETTE M FAGNANT PHONE NO : 781-982-1900 77 ACCORD PARK DR., D-7 SE DECISION MADE: 01-JUN-00 NORWELL, MA 02061 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOVAC7 HITESYS S.P.A. 510(k) NO: K990209(TRADITIONAL) ATTN: WALTER E GUNDAKER PHONE NO : 757-258-9722 1592 HARBOR ROAD SE DECISION MADE: 22-JUN-00 WILLIAMSBURG, VA 23185 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODULAR ROTATING HINGE KNEE CROSSOVER TIBIAL BEARING COMPONENTS HOWMEDICA OSTEONICS CORP. 510(k) NO: K001548(SPECIAL) ATTN: JENNIFER A DAUDELIN PHONE NO : 201-507-7283 359 VETERANS BLVD. SE DECISION MADE: 07-JUN-00 RUTHERFORD, NJ 07070-2584 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CALCIUM SULFATE PELLETS HOWMEDICA OSTEONICS CORP. 510(k) NO: K001559(TRADITIONAL) ATTN: KAREN ARIEMMA PHONE NO : 201-760-8187 59 ROUTE 17 SE DECISION MADE: 20-JUN-00 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODEL 473SI-64E QUADRATURE LOWER EXTREMITY COIL IGC-MEDICAL ADVANCES, INC. 510(k) NO: K001312(TRADITIONAL) ATTN: THOMAS E TYNES PHONE NO : 414-258-3808 10437 INNOVATION DRIVE SE DECISION MADE: 20-JUN-00 MILWAUKEE, WI 53226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SELF ADHERING NAVIGUS GUIDE IMAGE-GUIDED NEUROLOGICS, INC. 510(k) NO: K001192(TRADITIONAL) ATTN: DAVID M LEE PHONE NO : 321-757-8990 2290 W. EAU GALLIE BLVD. SE DECISION MADE: 07-JUN-00 MELBOURNE, FL 32935 510(k) STATEMENT DEVICE: XPLORER 1000 IMAGING DYNAMICS CORPORATION 510(k) NO: K992955(TRADITIONAL) ATTN: ROBIN WINSOR PHONE NO : 403 251 9939 151,2340 PEGASUS WAY, NE SE DECISION MADE: 02-JUN-00 CALGARY, ALBERTA, CANADA T2E 8M5 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRANS FX ADJUSTABLE PIN TO BAR CLAMP IMMEDICA, INC. 510(k) NO: K001084(TRADITIONAL) ATTN: ROY BOGERT PHONE NO : 973-635-9040 100 PASSAIC AVE. SE DECISION MADE: 15-JUN-00 CHATHAM, NJ 07928-2848 510(k) STATEMENT DEVICE: THE IMPLEX HEDROCEL MODULAR ELLIPTICAL ACETABULAR CUP IMPLEX CORP. 510(k) NO: K001039(ABBREVIATED) ATTN: JOHN SCHALAGO PHONE NO : 201-818-1800 80 COMMERCE DR. SE DECISION MADE: 15-JUN-00 ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUANTA LITE LKM-1 ELISA INOVA DIAGNOSTICS, INC. 510(k) NO: K000535(TRADITIONAL) ATTN: GARY L NORMAN PHONE NO : 858-586-9900 10180 SCRIPPS RANCH BLVD. SE DECISION MADE: 07-JUN-00 SAN DIEGO, CA 92131-1234 510(k) STATEMENT DEVICE: ORTHOCEPH OC100 D INSTRUMENTARIUM CORP. 510(k) NO: K001439(TRADITIONAL) ATTN: TOMMI JOKINIEMI PHONE NO : 300 WEST EDGERTON AVENUE SE DECISION MADE: 22-JUN-00 MILWAUKEE, WI 53207 510(k) STATEMENT DEVICE: DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM) INSTRUMENTARIUM IMAGING, INC. 510(k) NO: K000976(TRADITIONAL) ATTN: MAX LINDERT PHONE NO : 414-747-1030 300 WEST EDGERTON AVENUE SE DECISION MADE: 01-JUN-00 MILWAUKEE, WI 53207 510(k) STATEMENT DEVICE: IL TEST LIQUID ANTITHROMBIN INSTRUMENTATION LABORATORY CO. 510(k) NO: K994238(TRADITIONAL) ATTN: CAROL MARBLE PHONE NO : 781-861-4467 113 HARTWELL AVE SE DECISION MADE: 23-JUN-00 LEXINGTON, MA 02173 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPERM WASH MEDIUM, CAT# 2003/2005 INVITROCARE, INC. 510(k) NO: K000989(TRADITIONAL) ATTN: RPBERT E LOVINS PHONE NO : 858-452-1986 11408 SORRENTO VALLEY RD. SE DECISION MADE: 08-JUN-00 SUITE 202 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92121 DEVICE: IVC THREE BLASTOCYST MEDIUM, CAT # 2007 INVITROCARE, INC. 510(k) NO: K001113(TRADITIONAL) ATTN: ROBERT E LOVINS PHONE NO : 858-452-1986 11408 SORRENTO VALLEY RD. SE DECISION MADE: 13-JUN-00 SUITE 202 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92121 DEVICE: SIGNUM J.F. JELENKO & CO., INC. 510(k) NO: K001360(TRADITIONAL) ATTN: RAPHAEL JUDKINS PHONE NO : 800-431-1785 99 BUSINESS PARK DR. SE DECISION MADE: 20-JUN-00 ARMONK, NY 10504 510(k) STATEMENT DEVICE: QUART ARTERIAL FILTER, MODEL HBF 140 JOSTRA MEDIZINTECHNIK AG 510(k) NO: K001787(TRADITIONAL) ATTN: KATHY JOHNSON PHONE NO : 302-454-9959 2035 SUNSET LAKE ROAD SE DECISION MADE: 30-JUN-00 NEWARK, DE 19702 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KSEA MANHES PNEUMOTROCAR KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K000769(TRADITIONAL) ATTN: KEVIN A KENNAN PHONE NO : 310-410-2769 600 CORPORATE POINTE SE DECISION MADE: 01-JUN-00 CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYDRO-CAST BIS-ACRYL TEMPORARY CROWN AND BRIDGE MATERIAL, MODEL KAY SEE DENTAL MFG. CO. 510(k) NO: K001309(TRADITIONAL) ATTN: CLARK SMITH PHONE NO : 816-842-2817 124 EAST MISSOURI AVE. SE DECISION MADE: 13-JUN-00 KANSAS CITY, MO 64106-1294 510(k) STATEMENT DEVICE: AUDIOSCREENER OAE + ABR KEDLY INC. 510(k) NO: K001058(TRADITIONAL) ATTN: RANDALL J KROHN PHONE NO : 636-349-7770 920 S. HIGHWAY DRIVE SE DECISION MADE: 02-JUN-00 ST. LOUIS, MO 63026 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LAXTEX POWDERED EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (1 KOSSAN LATEX INDUSTRIES (M) SDN. B510(k) NO: K001557(TRADITIONAL) ATTN: LIM KWAN HWA PHONE NO : 603 392 7616 LOT 16632, 5-1/4 MILES, SE DECISION MADE: 09-JUN-00 JALAN MERU 510(k) STATEMENT KELANG, SELANGOR, MALAYSIA 41050 DEVICE: MACH 7 KREATIV, INC. 510(k) NO: K990060() ATTN: JOSEPH FOREHAND PHONE NO : 619-514-4235 9025 BALBOA AVE. SE DECISION MADE: 15-JUN-00 SAN DIEGO, CA 92123 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPAQUE HERRICK PLUG, 0.3MM; 0.5MM; O.7MM LACRIMEDICS, INC. 510(k) NO: K001737(SPECIAL) ATTN: BRIAN P LOGAN PHONE NO : 360-376-7095 310 PRUNE ALLEY SE DECISION MADE: 19-JUN-00 EASTSOUND, WA 98245 510(k) STATEMENT DEVICE: URANUS, COMFORTOUCH LASER SYSTEM LASER MAX MEDICAL TECHNOLOGIES COR510(k) NO: K001031(TRADITIONAL) ATTN: PAUL Y FANG PHONE NO : 559-651-2222 1601 NORTH CLANCY STREET SE DECISION MADE: 29-JUN-00 VISALIA, CA 93291-9263 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LEICA COLPOSCOPE LEICA MICROSCOPY SYSTEMS LTD. 510(k) NO: K000707(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001 55 NORTHERN BLVD. SE DECISION MADE: 27-JUN-00 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA GREAT NECK, NY 11021 DEVICE: TRI-BALL LEVENTON, S.A. 510(k) NO: K994074(TRADITIONAL) ATTN: JOAQUIM SORIANO PHONE NO : 34 93 6532011 POLIGONO CAN SUYER, 11 SE DECISION MADE: 08-JUN-00 SANT ANDREU DE LA BARCA 510(k) STATEMENT BARCELONA, SPAIN 08740 DEVICE: VFSS IMAGER, MODEL SIS-300 LIFECARE IMAGING INTL., LTD. 510(k) NO: K000987(TRADITIONAL) ATTN: RICHARD A ADAMS PHONE NO : 815-477-1290 8411 PYOTT RD. SE DECISION MADE: 01-JUN-00 LAKE IN THE HILLS, IL 60102 510(k) STATEMENT DEVICE: L720 EXAMINATION CHAIR LUNEAU GYNECOLOGIE SA 510(k) NO: K001261(TRADITIONAL) ATTN: BERNARD HOEL PHONE NO : 330 237 252525 BP 252 SE DECISION MADE: 08-JUN-00 CHARTRES CEDEX, FRANCE 28005 510(k) STATEMENT DEVICE: MACROPOREDX DISTRACTOR SYSTEM MACROPORE, INC. 510(k) NO: K000992(TRADITIONAL) ATTN: KENNETH K KLEINHENZ PHONE NO : 858-458-0900 6740 TOP GUN ST. SE DECISION MADE: 26-JUN-00 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRASIM CT SYSTEM MARCONI MEDICAL SYSTEMS 510(k) NO: K001088(TRADITIONAL) ATTN: ROBERT L TUROCY PHONE NO : 440-483-3528 595 MINER RD. SE DECISION MADE: 22-JUN-00 HIGHLAND HEIGHTS, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MASIF POWDER-FREE PATIENT EXAMINATION GLOVES MASIF HEALTHCARE PRODUCTS SDN. BHD510(k) NO: K000377(TRADITIONAL) ATTN: YEOH SENG GUAN PHONE NO : 605 357 1949 LADANG PINJI, BAHAGIAN SENGAT, SE DECISION MADE: 09-JUN-00 KAMPUNG KEPAYANG, 510(k) STATEMENT IPOH, PERAK, DARUL RIDZUAN, MALAYSIA 31300 DEVICE: MAXHEALTH WHEELCHAIR, MODEL HE-8631, HE-8621, HE-8651 MAXHEALTH CORP. 510(k) NO: K001252(TRADITIONAL) ATTN: LEWIS WARD PHONE NO : 303-530-3279 4655 KIRKWOOD COURT SE DECISION MADE: 12-JUN-00 BOULDER, CO 80301 510(k) STATEMENT DEVICE: EUDERMIC PF POWDER-FREE SURGICAL GLOVES MAXXIM MEDICAL, INC. 510(k) NO: K001343(ABBREVIATED) ATTN: PALLIE STODDARD PHONE NO : 864-369-7391 308 CHURCH STREET SE DECISION MADE: 12-JUN-00 HONE PATH, SC 29654 510(k) STATEMENT DEVICE: METROFOCAL TORIC (HIOXIFILCON A) SOFT (MULTIFOCAL) DAILY WEAR CO MED VICE CONSULTING INC. 510(k) NO: K001584(TRADITIONAL) ATTN: MARTIN DALSING PHONE NO : 970-243-5490 623 GLACIER DRIVE SE DECISION MADE: 13-JUN-00 GRAND JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 MEDEFIL, INC. 510(k) NO: K993518(TRADITIONAL) ATTN: PRADEEP AGGARWAL PHONE NO : 847-895-3000 492 LUNT AVENUE SE DECISION MADE: 12-JUN-00 SCHAUMBURG, IL 60193 510(k) STATEMENT DEVICE: MEDI-CULT M3 MEDIUM MEDI-CULT A/S 510(k) NO: K991331(TRADITIONAL) ATTN: RONALD G LEONARDI PHONE NO : 619-586-0751 9915 CAM. CHIRIMOLLA SE DECISION MADE: 20-JUN-00 SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDI-CULT HYALURONIDASE; MEDI-CULT A/S 510(k) NO: K991334(TRADITIONAL) ATTN: RONALD G LEONARDI PHONE NO : 619-586-0751 9915 CAM. CHIRIMOLLA SE DECISION MADE: 20-JUN-00 SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PBN HYSTERO-SALPINGOGRAPHY CATHETER SET MEDICAL DEVICE TECHNOLOGIES, INC. 510(k) NO: K000433(TRADITIONAL) ATTN: KARL SWARTZ PHONE NO : 352-338-0440 3600 S.W. 47TH AVE. SE DECISION MADE: 16-JUN-00 GAINESVILLE, FL 32608 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDTRONIC AVE BRIDGE X3 STENT MEDTRONIC AVE, INC. 510(k) NO: K000744(TRADITIONAL) ATTN: SUSAN WALTON PHONE NO : 707-591-7315 2170 NORTHPOINT PARKWAY SE DECISION MADE: 05-JUN-00 SANTA ROSA, CA 95407 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DYNA-LOK CLASSIC SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K001532(SPECIAL) ATTN: RICHARD W TREHARNE, PH.D. PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 16-JUN-00 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CD HORIZON ECLIPSE MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K001066(TRADITIONAL) ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PL. SE DECISION MADE: 22-JUN-00 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZEPHIR ANTERIOR CERVICAL PLATE SYSTEM MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K994239(TRADITIONAL) ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PL. SE DECISION MADE: 19-JUN-00 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STEATHSTATION TREATMENT GUIDANCE PLATFORM MEDTRONIC SURGICAL NAVIGATION 510(k) NO: K001801(SPECIAL) ATTN: VICTORIA RENDON PHONE NO : 303-439-9709 530 COMPTON ST. SE DECISION MADE: 30-JUN-00 BROOMFIELD, CO 80020 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STEALTHSTATION SYSTEM GOLDENEYE MICRO-MAGNETIC TRACKING SYSTEM MEDTRONIC SURGICAL NAVIGATION TECH510(k) NO: K001284(TRADITIONAL) ATTN: VICTORIA RENDON PHONE NO : 303-439-9709 530 COMPTON ST. SE DECISION MADE: 12-JUN-00 BROOMFIELD, CO 80020 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLACER MODEL 6232 STEERABLE STYLET MEDTRONIC, INC. 510(k) NO: K000955(TRADITIONAL) ATTN: MIKE JOHNSON PHONE NO : 612-514-9835 7000 CENTRAL AVENUE N.E. SE DECISION MADE: 16-JUN-00 MINNEAPOLIS, MN 55432-3576 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEMCATH UROLOGY INTRODUCER SHEATH, MODEL 201 MEMCATH TECHNOLOGIES LLC 510(k) NO: K000767(TRADITIONAL) ATTN: MARC JAKER PHONE NO : 651-450-7400 1777 OAKDALE AVENUE SE DECISION MADE: 05-JUN-00 WEST ST. PAUL, MN 55118-4031 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: METROFOCAL TORIC (POLYMACON) SOFT (MULTIFOCAL) DAILY WEAR CONTAC METRO OPTICS OF AUSTIN, INC. 510(k) NO: K001620(TRADITIONAL) ATTN: MARTIN D ALSING PHONE NO : 970-243-5490 623 GLACIER DRIVE SE DECISION MADE: 13-JUN-00 GRAND JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014" DIAMETER, 145CM LENGTH MICRO THERAPEUTICS, INC. 510(k) NO: K001454(SPECIAL) ATTN: MARIBELLE AGUINALDO PHONE NO : 949-837-3700 2 GOODYEAR SE DECISION MADE: 07-JUN-00 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CEDIA DAU 6-ACETYLMORPHINE ASSAY MICROGENICS CORP. 510(k) NO: K001178(TRADITIONAL) ATTN: CYNTHIA MERRELL PHONE NO : 510-979-5068 46360 FREMONT BLVD. SE DECISION MADE: 09-JUN-00 FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PIPET CURET MILEX PRODUCTS, INC. 510(k) NO: K001545(SPECIAL) ATTN: CARA FURLONG PHONE NO : 773-736-5500 4311 NORTH NORMANDY AVENUE SE DECISION MADE: 15-JUN-00 CHICAGO, IL 60634 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER MINNTECH CORP. 510(k) NO: K991137(TRADITIONAL) ATTN: LYNN LUEDERS PHONE NO : 612-553-3300 14605 28TH AVE. NORTH SE DECISION MADE: 08-JUN-00 MINNEAPOLIS, MN 55447 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABSOLUTE HCG PREGNANCY TEST MIZUHO USA, INC. 510(k) NO: K000844(TRADITIONAL) ATTN: BENEDICT ZIN PHONE NO : 619-457-9734 6730 MESA RIDGE RD., SUITE D SE DECISION MADE: 16-JUN-00 SAN DIEGO, CA 92121 510(k) STATEMENT DEVICE: KLINIDRAPE SURGICAL DRAPES MOLNLYCKE HEALTH CARE INC 510(k) NO: K000906(TRADITIONAL) ATTN: MIGUEL A NEGRON PHONE NO : 610-499-3383 500 BALDWIN TOWER SE DECISION MADE: 23-JUN-00 EDDYSTONE, PA 19022 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BREAST IMMOBILIZATION DEVICE MR-BY 160 MRI DEVICES CORP. 510(k) NO: K001303(TRADITIONAL) ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402 1515 PARAMOUNT DRIVE SE DECISION MADE: 20-JUN-00 WAUKESHA, WI 53186 510(k) STATEMENT DEVICE: HRW-42 WRIST ARRAY COIL FOR 1.0 TESLA MRI DEVICES CORP. 510(k) NO: K001713(SPECIAL) ATTN: TOM SCHUBERT PHONE NO : 262-524-1402 1515 PARAMOUNT DRIVE SE DECISION MADE: 14-JUN-00 WAUKESHA, WI 53186 510(k) STATEMENT DEVICE: ALLON 2001 MTRE ADVANCED TECHNOLOGY LTD. 510(k) NO: K001546(SPECIAL) ATTN: PAUL DRYDEN PHONE NO : 317-335-3780 6329 W. WATERVIEW CT. SE DECISION MADE: 08-JUN-00 MCCORDSVILLE, IN 46055 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHOENIX EPIDURAL & SPINAL NEEDLES MYCO MEDICAL SUPPLIES, INC. 510(k) NO: K990519(TRADITIONAL) ATTN: SANJIV KUMAR PHONE NO : 919-678-0680 101 ROSE VALLEY WOODS DR. SE DECISION MADE: 02-JUN-00 CARY, NC 27513 510(k) STATEMENT DEVICE: NBS CONNECTING TUBE SET NBS PRODUCTS CO 510(k) NO: K001068(TRADITIONAL) ATTN: CHARLES E MEISCH PHONE NO : 732-745-9292 257 LIVINGSTON AVE. SE DECISION MADE: 14-JUN-00 NEW BRUNSWICK, NJ 08901 510(k) STATEMENT DEVICE: MODIFICATION TO NC-STAT NEUROMETRIX, INC. 510(k) NO: K000565(TRADITIONAL) ATTN: CYNTHIA J.M. NOLTE PHONE NO : 919-859-4207 49 PLAIN ST. SE DECISION MADE: 27-JUN-00 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NICOLET EME LEGEND TC22 NICOLET VASCULAR INC. 510(k) NO: K993939(TRADITIONAL) ATTN: DAVID W WAGNER PHONE NO : 303-431-9400 6355 JOYCE DR. SE DECISION MADE: 29-JUN-00 GOLDEN, CO 80403 510(k) STATEMENT DEVICE: MULTI-RACIAL REFERENCE POPULATION FOR PDEXA AND DISCOVERY NORLAND MEDICAL SYSTEMS, INC. 510(k) NO: K993176(TRADITIONAL) ATTN: TERRY SCHWALENBERG PHONE NO : 920-563-8486 W-6340 HACKBARTH RD. SE DECISION MADE: 20-JUN-00 FORT ATKINSON, WI 53538-8999 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENGAGE JAW INSERTS NOVARE SURGICAL SYSTEMS, INC. 510(k) NO: K992980(TRADITIONAL) ATTN: NOEL MESSENGER PHONE NO : 650-529-2850 10231 BUBB RD. SE DECISION MADE: 08-JUN-00 CUPERTINO, CA 95014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECTROSURGICAL ELECTRODE FAMILY, MODEL 20-2 NEEDLE BALLOON CATH NOVASYS MEDICAL, INC. 510(k) NO: K001150(TRADITIONAL) ATTN: THAMAS WEHMAN PHONE NO : 408-730-6300 687 NO. PASTORIA AVENUE SE DECISION MADE: 29-JUN-00 SUNNYVALE, CA 94086 510(k) STATEMENT DEVICE: ELECTROSURGICAL ELECTRODE FAMILY NOVASYS MEDICAL, INC. 510(k) NO: K001151(TRADITIONAL) ATTN: THOMAS WEHMAN PHONE NO : 408-730-6300 687 NO. PASTORIA AVENUE SE DECISION MADE: 27-JUN-00 SUNNYVALE, CA 94086 510(k) STATEMENT DEVICE: NORMOCARB STERILE BICARBONATE RENAL DIALYSIS NOVEX PHARMA 510(k) NO: K001059(TRADITIONAL) ATTN: JOSSEPH W BEYGER PHONE NO : 905 508 2552 380 ELGIN MILLS ROAD EAST SE DECISION MADE: 30-JUN-00 RICHMOND HILL, ONTARIO, CANADA L4C510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON OCULAR CONCEPTS LLC 510(k) NO: K001326(TRADITIONAL) ATTN: KEVIN SCHOU PHONE NO : 503-699-2644 4035 SW MERCANTILE DRIVE SE DECISION MADE: 13-JUN-00 SUITE 208 510(k) SUMMARY AVAILABLE FROM FDA PORTLAND, OR 97035-2591 DEVICE: OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQU OLYMPUS AMERICA, INC. 510(k) NO: K994069(TRADITIONAL) ATTN: LAURA STORMS-TYLER PHONE NO : 516-844-5688 TWO CORPORATE CENTER DR. SE DECISION MADE: 02-JUN-00 MELVILLE, NY 11042-1179 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQU OLYMPUS AMERICA, INC. 510(k) NO: K994106(TRADITIONAL) ATTN: LAURA STORMS- TYLER PHONE NO : 516-844-5688 TWO CORPORATE CENTER DR. SE DECISION MADE: 02-JUN-00 MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-75 OMRON HEALTHCARE, INC. 510(k) NO: K001670(SPECIAL) ATTN: OSAMU SHIRASAKI PHONE NO : 847-680-6200 300 LAKEVIEW PKWY. SE DECISION MADE: 30-JUN-00 VERNON HILLS, IL 60061 510(k) STATEMENT DEVICE: ULTRA COMPACT WRIST BLOOD PRESSURE MONITOR WITH INTELLISENSE, MO OMRON HEALTHCARE, INC. 510(k) NO: K001671(SPECIAL) ATTN: OSAMU SHIRASAKI PHONE NO : 847-680-6200 300 LAKEVIEW PKWY. SE DECISION MADE: 30-JUN-00 VERNON HILLS, IL 60061 510(k) STATEMENT DEVICE: ULTRA VUE 55/P & C (METHAFILCON A) SOFT (MULTIFOCAL, SPHERICAL, OPTI-CENTRE LABORATORIES 510(k) NO: K001227(TRADITIONAL) ATTN: MARTIN DALSING PHONE NO : 970-243-5490 623 GLACIER DRIVE SE DECISION MADE: 29-JUN-00 GRAND JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTION CARE SYSTEM FOR THE CLEANING AND DISINFECTING OF SOFT (HY OPTISONIC, INC. 510(k) NO: K000998(TRADITIONAL) ATTN: JOHN M SZABOCSIK PHONE NO : 312-553-0828 203 NORTH WABASH AVENUE SE DECISION MADE: 05-JUN-00 SUITE #1200 510(k) SUMMARY AVAILABLE FROM FDA CHICAGO, IL 60601 DEVICE: OPUS 10 DENTAL DIODE LASER OPUSDENT LTD. 510(k) NO: K000990(TRADITIONAL) ATTN: SHOSHANA FRIEDMAN PHONE NO : 972 977 18130 117 AHUZAH ST. SE DECISION MADE: 23-JUN-00 RA'ANANNA, ISRAEL 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MDA D-DIMER ORGANON TEKNIKA CORP. 510(k) NO: K000492(TRADITIONAL) ATTN: RON SANYAL PHONE NO : 919-620-2373 100 AKZO AVE. SE DECISION MADE: 07-JUN-00 DURHAM, NC 27712 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULTI ADJUSTABLE FACE MASK ORTHO TECHNOLOGY 510(k) NO: K000358(TRADITIONAL) ATTN: BRIAN LEAGHTY PHONE NO : 800-999-3161 8909 REGENTS PARB DR., #410 SE DECISION MADE: 09-JUN-00 TAMPA, FL 33647 510(k) STATEMENT DEVICE: VITROS CHEMISTRY PRODUCTS CREA DT SLIDES; VITROS CHEMISTRY PRODU ORTHO-CLINICAL DIAGNOSTICS 510(k) NO: K001769(SPECIAL) ATTN: DARLENE J PHILLIPS PHONE NO : 716-453-4253 100 INDIGO CREEK DRIVE SE DECISION MADE: 21-JUN-00 ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITROS CHEMISTRY PRODUCTS AST SLIDE AND CHEMISTRY PRODUCTS CALIB ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K001679(SPECIAL) ATTN: MARLENE A SHULMAN PHONE NO : 716-453-4041 100 INDIGO CREEK DRIVE SE DECISION MADE: 28-JUN-00 ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OMEGA II MODULAR TOTAL HIP SYSTEM OSTEOIMPLANT TECHNOLOGY, INC. 510(k) NO: K000817(TRADITIONAL) ATTN: SAM SON PHONE NO : 410-785-0700 11201 PEPPER RD. SE DECISION MADE: 08-JUN-00 HUNT VALLEY, MD 21031-1201 510(k) STATEMENT DEVICE: LATEX SURGEON SURGEON'S GLOVES POWDER-FREE WITH PROTEIN CONTENT P.T. MAJA AGUNG LATEXINDO 510(k) NO: K001274(TRADITIONAL) ATTN: EMMY TJOENG PHONE NO : 626-913-1798 889 SOUTH AZUSA AVENUE SE DECISION MADE: 23-JUN-00 INDUSTRY, CA 91748 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, PACE MEDICAL 510(k) NO: K001180(TRADITIONAL) ATTN: ROBERT C MACE PHONE NO : 781-890-5656 391 TOTTEN POND RD. SE DECISION MADE: 27-JUN-00 WALTHAM, MA 02451 510(k) STATEMENT DEVICE: HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATION GL PAMITEX INDUSTRIES SDN BHD 510(k) NO: K000952(TRADITIONAL) ATTN: SAID AWANG PHONE NO : 606 631 3122 2 1/2 MILES, JALAN RASAH SE DECISION MADE: 30-JUN-00 SEREMBAN, NAGERI SEMBILAN 510(k) STATEMENT DARUL KHUSUS, MALAYSIA 70300 DEVICE: POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVES PAMITEX INDUSTRIES SDN BHD 510(k) NO: K001672(TRADITIONAL) ATTN: SAID AWANG PHONE NO : 011 606 6313122 2 1/2 MILES, JALAN RASAH SE DECISION MADE: 23-JUN-00 SEREMBAN, NAGERI SEMBILAN 510(k) STATEMENT DARUL KHUSUS, MALAYSIA 70300 DEVICE: POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR PAMITEX INDUSTRIES SDN BHD 510(k) NO: K001674(TRADITIONAL) ATTN: SAID AWANG PHONE NO : 011 606 6313122 2 1/2 MILES, JALAN RASAH SE DECISION MADE: 30-JUN-00 SEREMBAN, NAGERI SEMBILAN 510(k) STATEMENT DARUL KHUSUS, MALAYSIA 70300 DEVICE: OPTIRAD PERMEDICS, INC. 510(k) NO: K993895(TRADITIONAL) ATTN: GREG HOLLAND PHONE NO : 949-262-0411 3722 SAUSALITO AVE. SE DECISION MADE: 02-JUN-00 IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN PERUSAHAAN GETAH ASAS SDN BHD 510(k) NO: K001529(TRADITIONAL) ATTN: TAN KONG CHANG PHONE NO : 603 391 1949 LOT 754, JALAN HAJI SIRAT SE DECISION MADE: 12-JUN-00 SELANGOR, MALAYSIA 41720 510(k) STATEMENT DEVICE: SYNERGY HEAD/NECK COIL PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K001331(TRADITIONAL) ATTN: PETER ALTMAN PHONE NO : 203-926-7674 710 BRIDGEPORT AVE. SE DECISION MADE: 09-JUN-00 SHELTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODEL 4000 EEG MONITOR WITH PSI (PSA4000) PHYSIOMETRIX, INC. 510(k) NO: K001069(TRADITIONAL) ATTN: DAWN E FRAZER PHONE NO : 978-670-2422 FIVE BILLERICA PARK, SE DECISION MADE: 30-JUN-00 101 BILLERICA AVE. 510(k) SUMMARY AVAILABLE FROM FDA NORTH BILLERICA, MA 01862 DEVICE: SERAGARD INJECTION PATCH PLATINUM SERVICES, INC. 510(k) NO: K001240(TRADITIONAL) ATTN: NANCY Y STREET PHONE NO : 302-836-9919 115 BOISE STREET SE DECISION MADE: 21-JUN-00 DEQUINCY, LA 70633 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPERMICIDAL LUBRICATED MALE LATEX CONDOM PLEASURE LATEX PRODUCTS SDN. BHD. 510(k) NO: K001377(ABBREVIATED) ATTN: LIM KOI-YONG PHONE NO : 603 874 0784 LOT 1365, 17TH MILES, JALAN SE DECISION MADE: 08-JUN-00 SUNGAI SEMBILANG 510(k) STATEMENT JERAM, SELANGOR, MALAYSIA 45800 DEVICE: BOFOR REVISION COUP PLUS ORTHOPEDICS 510(k) NO: K993874(TRADITIONAL) ATTN: HARTMUT LOCH PHONE NO : 858-455-2400 3550 GENERAL ATOMICS CT. SE DECISION MADE: 05-JUN-00 BLDG. 15-100 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92121-1122 DEVICE: PULSION CONTINUOUS PULSE CONTOUR CARDIAC OUTPUT (PICCO) SYSTEM PULSION MEDICAL SYSTEMS, INC. 510(k) NO: K001762(TRADITIONAL) ATTN: ULF BORG PHONE NO : 877-655-8844 20462-A CHARTWELL CENTER DRIVE SE DECISION MADE: 13-JUN-00 PO BOX 2637 510(k) SUMMARY AVAILABLE FROM FDA CORNELIUS, NC 28031 DEVICE: HEALTH-PLUS, SANITEX, RELIANCE, POWDERED LATEX EXAM GLOVES CONTA PWA INDUSTRIES SDN. BHD. 510(k) NO: K001475(TRADITIONAL) ATTN: AZHARSYAH M YASSIN PHONE NO : 609 567 0835 LOT 93, SEMAMBU INDUST. ESTATE SE DECISION MADE: 13-JUN-00 KUANTAN, PAHANG, MALAYSIA 25350 510(k) STATEMENT DEVICE: HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE LATEX EXAMINATION GL PWA INDUSTRIES SDN. BHD. 510(k) NO: K001485(TRADITIONAL) ATTN: AZHARSYAH M YASSIN PHONE NO : 609 567 0835 LOT 93, SEMAMBU INDUST. ESTATE SE DECISION MADE: 13-JUN-00 KUANTAN, PAHANG, MALAYSIA 25350 510(k) STATEMENT DEVICE: FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM QUALISYS DIAGNOSTICS, INC. 510(k) NO: K994419(TRADITIONAL) ATTN: VIJAY K MAHANT PHONE NO : 760-918-9165 2042 CORTE DEL NOGAL SE DECISION MADE: 28-JUN-00 CARLSBAD, CA 92009 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT QUANTASE LTD. 510(k) NO: K000754(TRADITIONAL) ATTN: R. STEWART CAMPBELL PHONE NO : 44 017 38444102 3 RIVERVIEW BUSINESS PARK SE DECISION MADE: 19-JUN-00 FRIARTON ROAD 510(k) STATEMENT PERTH, SCOTLAND, UNITED KINGDOM PH2 8DF DEVICE: XPLAN 2.1 RADIONICS, INC. 510(k) NO: K001700(SPECIAL) ATTN: NANCY C MACDONALD PHONE NO : 781-272-1233 22 TERRY AVE. SE DECISION MADE: 28-JUN-00 BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIPAP DUET LX BI-LEVEL SYSTEM RESPIRONICS, INC. 510(k) NO: K000994(SPECIAL) ATTN: DAVID J VANELLA PHONE NO : 724-733-5866 1001 MURRY RIDGE LANE SE DECISION MADE: 22-JUN-00 MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RETRAX RETRACTING NEEDLE SYRINGE, SIZE 3CC RETRAX SAFETY SYSTEMS, INC. 510(k) NO: K001017(TRADITIONAL) ATTN: DAVID GARVIN PHONE NO : 305-371-8166 1401 BRICKELL AVE SUITE 1480 SE DECISION MADE: 02-JUN-00 MIAMI, FL 33131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E RHIGENE, INC 510(k) NO: K000336(TRADITIONAL) ATTN: DAVE KOLESAR PHONE NO : 847-375-9091 455 STATE ST., SE DECISION MADE: 09-JUN-00 SUITE 104 510(k) STATEMENT DES PLAINES, IL 60068 DEVICE: NEPHROSCOPE, 12 DEGREES; DIAPHRAGM VALVE; IRRIGATION ATTACHMENT; RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K994223(TRADITIONAL) ATTN: ROBERT L CASARSA PHONE NO : 847-913-1113 353 CORPORATE WOODS PKWY. SE DECISION MADE: 05-JUN-00 VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECSYS ANTI-TPO CALCHECK ROCHE DIAGNOSTICS CORP. 510(k) NO: K001014(TRADITIONAL) ATTN: KAY A TAYLOR PHONE NO : 317-576-3544 9115 HAGUE RD. SE DECISION MADE: 01-JUN-00 INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ONTRAK TESTCUP 502, MODEL 3016641 ROCHE DIAGNOSTICS CORP. 510(k) NO: K001417(SPECIAL) ATTN: JENNIFER TRIBBETT PHONE NO : 317-576-3742 9115 HAGUE RD. SE DECISION MADE: 29-JUN-00 INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECSYS INSULIN CALCHECK ROCHE DIAGNOSTICS CORP. 510(k) NO: K001846(TRADITIONAL) ATTN: KAY TAYLOR PHONE NO : 317-576-3544 9115 HAGUE RD. SE DECISION MADE: 28-JUN-00 INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAFETYTIP MULTI-SAMPLE NEEDLE, SAFETYTIP BLOOD COLLECTION SYSTEM SAFETY MEDICAL SUPPLY INT,. INC. 510(k) NO: K993125(TRADITIONAL) ATTN: YOVETTE MUMFORD PHONE NO : 781-642-7171 135 BEAVER STREET 4TH FLOOR SE DECISION MADE: 20-JUN-00 WALTHAM, MA 02452-8424 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT SANGUI BIOTECH, INC. 510(k) NO: K992799(TRADITIONAL) ATTN: JOHN J KIANG PHONE NO : 714-429-7807 1508 BROOKHOLLOW DR., #354 SE DECISION MADE: 07-JUN-00 SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM SELFCARE, INC. 510(k) NO: K001427(SPECIAL) ATTN: CAROL A ADILETTO PHONE NO : 781-647-3900 200 PROSPECT ST. SE DECISION MADE: 02-JUN-00 WALTHAM, MA 02154-3457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULTIPLE PRIVATE LABELS, NITRILE EXAM GLOVES, POWDER-FREE (WHITE SHANGHAI POSEIDON PLASTIC PRODUCTS510(k) NO: K001549(TRADITIONAL) ATTN: JANNA P TUCKER PHONE NO : 775-342-2612 198 AVENUE DE LA D'EMERALD SE DECISION MADE: 12-JUN-00 SPARKS, NV 89434-9550 510(k) STATEMENT DEVICE: DISPOSABLE PVC POWDERED SYNTHETIC EXAM GLOVES SHANGHAI PT PLASTICS ENTERPRISE CO510(k) NO: K001601(TRADITIONAL) ATTN: PETER WANG PHONE NO : 011 862 157818521 268 YUSHU RD., CANGQIAO SE DECISION MADE: 23-JUN-00 TOWNSHIP, SONGJIANG COUNTY 510(k) STATEMENT SHANGHAI, CHINA DEVICE: DISPOSABLE PVC SYNTHETIC EXAMINATION GLOVES, POWDER FREE SHANGHAI PT PLASTICS ENTERPRISE CO510(k) NO: K001611(TRADITIONAL) ATTN: PETER WANG PHONE NO : 011 862 157818521 268 YUSHU RD., CANGQIAO SE DECISION MADE: 30-JUN-00 TOWNSHIP, SONGJIANG COUNTY 510(k) STATEMENT SHANGHAI, CHINA DEVICE: DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, GREEN COLOR SHEEN MORE ENT. CO., LTD. 510(k) NO: K001637(TRADITIONAL) ATTN: KEN HUANG PHONE NO : 011 886 55575937 NO.16, TOU KUNG SIX RD. SE DECISION MADE: 23-JUN-00 TOU-LIU EXPANDED INDUST. PARK 510(k) STATEMENT TOU-LIU, YUN-LIN, CHINA (TAIWAN) DEVICE: FUTURA SAFETY SYRINGE SHEILA W. PICKERING 510(k) NO: K000860(ABBREVIATED) ATTN: SHEILA W PICKERING PHONE NO : 650-969-6114 2081 LONGDEN CIRCLE SE DECISION MADE: 30-JUN-00 LOS ALTOS, CA 94024 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG HONGXIANG PLASTICS PR510(k) NO: K001834(TRADITIONAL) ATTN: JAMES CHU PHONE NO : 909-262-8860 12390 EAST END AVENUE SE DECISION MADE: 30-JUN-00 CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHETIC POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG HONGXIANG PLASTICS PR510(k) NO: K001862(TRADITIONAL) ATTN: JAMES CHU PHONE NO : 909-262-8860 12390 EAST END AVENUE SE DECISION MADE: 30-JUN-00 CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHIMADZU MOBILE X-RAY SYSTEM MUX-100 SERIES SHIMADZU CORP. 510(k) NO: K001517(ABBREVIATED) ATTN: MICHAEL FISHBACK PHONE NO : 310-217-8855 20101 SOUTH VERMONT AVENUE SE DECISION MADE: 27-JUN-00 TORRANCE, CA 90502-1328 510(k) STATEMENT DEVICE: MULTIX COMPACT K AND MULTIX L RADIOGRAPHIC X-RAY SYSTEMS SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K001201(TRADITIONAL) ATTN: MALGORZATA STANEK PHONE NO : 732-321-3950 186 WOOD AVENUE SOUTH SE DECISION MADE: 01-JUN-00 ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RECTOSIGHT RS 300-04 SIGHTLINE TECHNOLOGIES LTD. 510(k) NO: K994130(TRADITIONAL) ATTN: AHAVA STEIN PHONE NO : 972 979 20673 P.O. BOX 454 SE DECISION MADE: 30-JUN-00 GINOT, SHOMRON, ISRAEL 44853 510(k) STATEMENT DEVICE: INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568) SIGMA DIAGNOSTICS, INC. 510(k) NO: K001569(TRADITIONAL) ATTN: WILLIAM R GILBERT PHONE NO : 314-286-6693 545 SOUTH EWING AVE. SE DECISION MADE: 26-JUN-00 ST. LOUIS, MO 63103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM SIMS DELTEC, INC. 510(k) NO: K000842(TRADITIONAL) ATTN: LISA STONE PHONE NO : 651-628-7224 1265 GREY FOX RD. SE DECISION MADE: 08-JUN-00 ST. PAUL, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PC COATED FLUOROPLASTIC VENT TUBES SMITH & NEPHEW ENT. 510(k) NO: K000801(TRADITIONAL) ATTN: ALICIA FARAGE PHONE NO : 573-243-3799 2925 APPLING RD. SE DECISION MADE: 19-JUN-00 BARTLETT, TN 38133 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMITH + NEPHEW RF ARTHROSCOPIC WAND SYSTEM SMITH & NEPHEW, INC. 510(k) NO: K001226(TRADITIONAL) ATTN: MARK KIERAS PHONE NO : 978-749-1000 160 DASCOMB RD. SE DECISION MADE: 26-JUN-00 ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROPERFORATION INSTRUMENT SMITH & NEPHEW, INC. 510(k) NO: K001507(TRADITIONAL) ATTN: NICHOLAS CONDAKES PHONE NO : 508-261-3770 130 FORBES BLVD. SE DECISION MADE: 14-JUN-00 MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 SORENSON MEDICAL INC. 510(k) NO: K001287(TRADITIONAL) ATTN: R. DOUGLAS JACOB PHONE NO : 801-352-1888 1375 WEST 8040 SOUTH SE DECISION MADE: 09-JUN-00 WEST JORDAN, UT 84088-8320 510(k) STATEMENT DEVICE: THE WAND SPINTECH, INC. 510(k) NO: K992404(TRADITIONAL) ATTN: DANIEL J MANELLI PHONE NO : 202-261-1000 2000 M STREET, N.W., SUITE 700 SE DECISION MADE: 06-JUN-00 WASHINGTON, DC 20036 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STACKHOUSE SMOKE EVACUATOR, MODELS ST-3000, ST 3100 STACKHOUSE, INC. 510(k) NO: K001082(TRADITIONAL) ATTN: TOM GUTIERREZ PHONE NO : 760-778-7255 1100 BIRD CENTER DR. SE DECISION MADE: 15-JUN-00 PALM SPRINGS, CA 92262 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AC POWERED THERMAL CAUTERY UNIT STARION INSTRUMENTS 510(k) NO: K000893(TRADITIONAL) ATTN: BRIAN GRIGSBY PHONE NO : 408-741-8773 20665 4TH ST. SE DECISION MADE: 14-JUN-00 SARATOGA, CA 95070 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERMAL CAUTERY FORCEPS STARION INSTRUMENTS 510(k) NO: K001262(TRADITIONAL) ATTN: BRIAN GRIGSBY PHONE NO : 408-741-8773 20665 4TH ST. SE DECISION MADE: 14-JUN-00 SARATOGA, CA 95070 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STARION INSTRUMENTS POWER POINT CAUTERY CLAMP STARION INSTRUMENTS 510(k) NO: K001273(TRADITIONAL) ATTN: BRIAN GRIGSBY PHONE NO : 408-741-8773 20665 4TH ST. SE DECISION MADE: 14-JUN-00 SARATOGA, CA 95070 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERITEC AUTOCLAVE TAPES, MODEL CI122 & CI1234 STERITEC PRODUCTS, INC. 510(k) NO: K001649(ABBREVIATED) ATTN: LINDA NELSON PHONE NO : 303-660-4201 599 TOPEKA WAY, SUITE 700 SE DECISION MADE: 23-JUN-00 CASTLE ROCK, CO 80104 510(k) STATEMENT DEVICE: SUGAR CHEX ONE STRECK LABORATORIES, INC. 510(k) NO: K001443(TRADITIONAL) ATTN: PAUL KITTELSON PHONE NO : 402-691-7458 14124 INDUSTRIAL RD. SE DECISION MADE: 29-JUN-00 OMAHA, NE 68145-0625 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TEMPORARY GINGIVAL CUFF AND IMPRESSION POST AND IMPLANT ANALOG SULZER CALCITEK INC. 510(k) NO: K001786(SPECIAL) ATTN: FOSTER BOOP PHONE NO : 760-431-9515 1900 ASTON AVE. SE DECISION MADE: 21-JUN-00 CARLSBAD, CA 92008-7308 510(k) STATEMENT DEVICE: SULZER ORTHOPEDICS MS-30 FEMORAL STEM SULZER ORTHOPEDICS, INC. 510(k) NO: K001078(TRADITIONAL) ATTN: FRANCES E HARRISON PHONE NO : 512-432-9306 9900 SPECTRUM DR. SE DECISION MADE: 23-JUN-00 AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3.5 MM LAPAROSCOPE (LG100, LG103) SURGICAL IMAGE LABORATORIES, INC. 510(k) NO: K001594(SPECIAL) ATTN: ZOLTAN BALAZS PHONE NO : 800-917-2673 1456 WEST NEWPORT CENTER DRIVE SE DECISION MADE: 12-JUN-00 DEERFIELD BEACH, FL 33442 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHARMASEED, MODEL BT-103-2 SYNCOR INTERNATIONAL, INC. 510(k) NO: K993700(TRADITIONAL) ATTN: GARY GILMORE PHONE NO : 303-279-1914 1313 WASHINGTON AVENUE SE DECISION MADE: 02-JUN-00 GOLDEN, CO 80401 510(k) STATEMENT DEVICE: PHARMASEED, MODEL BT-125-2 SYNCOR INTERNATIONAL, INC. 510(k) NO: K993701(TRADITIONAL) ATTN: GARY GILMORE PHONE NO : 303-279-1914 1313 WASHINGTON AVENUE SE DECISION MADE: 09-JUN-00 GOLDEN, CO 80401 510(k) STATEMENT DEVICE: SYNTHES (USA) TROCHANTER STABILIZATION PLATE FOR DHS SYNTHES (USA) 510(k) NO: K000972(TRADITIONAL) ATTN: BONNIE J SMITH PHONE NO : 610-647-9700 1690 RUSSELL ROAD SE DECISION MADE: 16-JUN-00 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES (USA) ORIBITAL MESH PLATES SYNTHES (USA) 510(k) NO: K001311(TRADITIONAL) ATTN: BONNIE J SMITH PHONE NO : 610-647-9700 P.O. BOX 1766 SE DECISION MADE: 20-JUN-00 1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA PAOLI, PA 19301-1222 DEVICE: SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM SYNTHES (USA) 510(k) NO: K993335(TRADITIONAL) ATTN: SHERI L MUSGNUNG PHONE NO : 610-647-9700 1600 RUSSELL RD. SE DECISION MADE: 12-JUN-00 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOR 2000 T.C. MEDICAL INC. 510(k) NO: K984376(TRADITIONAL) ATTN: LINCOLN ONG PHONE NO : 612-935-8829 14710 ORCHARD ROAD SE DECISION MADE: 07-JUN-00 MINNETONKA, MN 55345 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OXYGEN SENSORS, MODELS CIR, C2R, R13, R15, RI7MED, R22MED, R23, TELEDYNE ANALYTICAL INSTRUMENTS 510(k) NO: K001095(TRADITIONAL) ATTN: RAY KHAJAVI PHONE NO : 626-934-1502 16830 CHESTNUT ST. SE DECISION MADE: 30-JUN-00 CITY OF INDUSTRY, CA 91749 510(k) STATEMENT DEVICE: TERUMO U-100 INSULIN SYRING TERUMO MEDICAL CORP. 510(k) NO: K001474(SPECIAL) ATTN: SANDI HARTKA PHONE NO : 410-392-7243 125 BLUE BALL ROAD SE DECISION MADE: 09-JUN-00 ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITH TERUMO MEDICAL CORP. 510(k) NO: K993772(TRADITIONAL) ATTN: GARRY A COURTNEY PHONE NO : 800-283-7866 125 BLUE BALL ROAD SE DECISION MADE: 05-JUN-00 ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3D-MSPECT THE REAGENTS OF THE UNIVERSITY OF 510(k) NO: K001026(TRADITIONAL) ATTN: SHEILA HEMEON-HEYER PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 20-JUN-00 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECHOCOM, IMAGECOM, DOKUCOM TOMTEC IMAGING SYSTEMS, GMBH 510(k) NO: K001592(SPECIAL) ATTN: FLORIAN EISENBERGER PHONE NO : 490 893 2175830 EDISONSTRASSE 6 SE DECISION MADE: 16-JUN-00 UNTERSCHLEISSHEIM, GERMANY D-85716510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AEQUALIS UNIVERSAL SHOULDER GLENOID TORNIER S.A. 510(k) NO: K994393(TRADITIONAL) ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640 200 GREGORY LANE SE DECISION MADE: 22-JUN-00 SUITE C-100 510(k) SUMMARY AVAILABLE FROM FDA PLEASANT HILL, CA 94523-3389 DEVICE: SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (MOXIFLOXACIN) TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K001036(TRADITIONAL) ATTN: CYNTHIA C KNAPP PHONE NO : 440-250-1665 29299 CLEMENS RD. SUITE 1-K SE DECISION MADE: 06-JUN-00 WESTLAKE, OH 44145 510(k) STATEMENT DEVICE: UEDA UDEX SUPER BP-2000 AUTOMATIC BLOOD PRESSURE RECORDING DEVIC UEDA AVANCER CORPORATION 510(k) NO: K993316(TRADITIONAL) ATTN: E.J. SMITH PHONE NO : 410-451-0639 PO BOX 4341 SE DECISION MADE: 09-JUN-00 CROFTON, MD 21114 510(k) STATEMENT DEVICE: MILLENNIA ACUPUNCTURE NEEDLE UNITED PACIFIC CO., LTD. 510(k) NO: K001718(TRADITIONAL) ATTN: DANIEL YE HUA PHONE NO : 626-458-8518 219 SOUTH RAYMOND AVE. SE DECISION MADE: 21-JUN-00 ALHAMBRA, CA 91801 510(k) STATEMENT DEVICE: UNIVEC TWO PIECE SYRINGE UNIVEC, INC. 510(k) NO: K000747(TRADITIONAL) ATTN: S. LEVINSON PHONE NO : 516-777-2000 22 DUBON CT. SE DECISION MADE: 08-JUN-00 FARMINGDALE, NY 11735 510(k) STATEMENT DEVICE: INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PELVIS COIL USA INSTRUMENTS, INC. 510(k) NO: K001209(TRADITIONAL) ATTN: RONY THOMAS PHONE NO : 330-562-1000 1515 DANNER DRIVE SE DECISION MADE: 01-JUN-00 AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HI-RES 9000 PHASED ARRAY CAROTID COIL USA INSTRUMENTS, INC. 510(k) NO: K001210(TRADITIONAL) ATTN: RONY THOMAS PHONE NO : 330-562-1000 1515 DANNER DRIVE SE DECISION MADE: 09-JUN-00 AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VARIS 1.4G VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K001643(SPECIAL) ATTN: LINDA S NASH PHONE NO : 650-424-6990 3100 HANSEN WAY M/S H-055 SE DECISION MADE: 23-JUN-00 PALO ALTO, CA 94304-1129 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VSCORE WITH EKG SIGNAL GATING VITAL IMAGES, INC. 510(k) NO: K001682(TRADITIONAL) ATTN: ROBERT C SAMEC PHONE NO : 612-915-8001 3300 FERNBROOK LANE NORTH SE DECISION MADE: 30-JUN-00 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA PLYMOUTH, MN 55447 DEVICE: SCANDINAVIAN IVF SCIENCES AB, G2.2 VITROLIFE AB/SCANDINAVIAN IVF SCIE510(k) NO: K000619(TRADITIONAL) ATTN: GARY L YINGLING PHONE NO : 202-496-7645 1900 K STREET, N.W. SE DECISION MADE: 27-JUN-00 WASHINGTON, DC 20006-1108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCANDINAVIAN IVF SCIENCES AB, HYBASE-1 VITROLIFE AB/SCANDINAVIAN IVF SCIE510(k) NO: K000627(TRADITIONAL) ATTN: GARY L YINGLING PHONE NO : 202-496-7500 1900 K STREET, N.W. SE DECISION MADE: 13-JUN-00 WASHINGTON, DC 20006-1108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIVANT MEDICAL BIOPSY MARKER SYSTEM VIVANT MEDICAL, INC. 510(k) NO: K000278(TRADITIONAL) ATTN: JACK W MOORMAN PHONE NO : 650-529-1238 3210-B ALPINE ROAD SE DECISION MADE: 23-JUN-00 PORTOLA VALLEY, CA 94028 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WAKO APOLIPOPROTEIN HIGH LEVEL CALIBRATOR WAKO CHEMICALS, USA, INC. 510(k) NO: K001004(TRADITIONAL) ATTN: TONYA MALLORY PHONE NO : 877-714-1924 1600 BELLWOOD RD. SE DECISION MADE: 01-JUN-00 RICHMOND, VA 23237 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WAKO HDL-C/LDL-C CALIBRATOR WAKO CHEMICALS, USA, INC. 510(k) NO: K001005(TRADITIONAL) ATTN: TONYA MALLORY PHONE NO : 800-992-9256 1600 BELLWOOD RD. SE DECISION MADE: 01-JUN-00 RICHMOND, VA 23237 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DELFIA NEONATAL IRT KIT WALLAC OY 510(k) NO: K993697(TRADITIONAL) ATTN: GUNNEL LAAKSONEN PHONE NO : 358 226 78111 MUSTIONKATU 6 SE DECISION MADE: 09-JUN-00 TURKU, FINLAND 20750 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED WALTER ABENDSCHEIN, M.D. 510(k) NO: K000827(TRADITIONAL) ATTN: WALTER ABENDSCHEIN PHONE NO : 301-656-4317 5530 WISCONSIN AVENUE SE DECISION MADE: 23-JUN-00 SUITE 705 510(k) SUMMARY AVAILABLE FROM FDA CHEVY CHASE, MD 20815 DEVICE: DIGITAL INTEGRATION SYSTEM, DIS2000 WELLINGTON MEDICAL SYSTEMS, INC. 510(k) NO: K001012(TRADITIONAL) ATTN: SCOTT AUGUST PHONE NO : 508-965-9850 19 HARVEST AVENUE SE DECISION MADE: 13-JUN-00 DARTMOUTH, MA 02747 510(k) STATEMENT DEVICE: ACTICOAT PRIMARY ANTIMICROBIAL DRESSING WESTAIM BIOMEDICAL INC. 510(k) NO: K992221(TRADITIONAL) ATTN: SALLY L MAHER PHONE NO : 603-775-7300 ONE HAMPTON RD., SUITE 302 SE DECISION MADE: 07-JUN-00 EXETER, NH 03842 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FIRST CHECK HOME DRUG TEST (THC) WORLDWIDE MEDICAL CORP. 510(k) NO: K993663(TRADITIONAL) ATTN: LARRY R PILOT PHONE NO : 202-496-7561 1900 K STREET, N.W. SE DECISION MADE: 23-JUN-00 WASHINGTON, DC 20006-1108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FIRST CHECK HOME DRUG TEST PANEL 3 WORLDWIDE MEDICAL CORP. 510(k) NO: K994138(TRADITIONAL) ATTN: LARRY R PILOT PHONE NO : 202-496-7561 1900 K STREET, N.W. SE DECISION MADE: 23-JUN-00 WASHINGTON, DC 20006-1108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FIRST CHECK HOME DRUG TEST PANEL 2 WORLDWIDE MEDICAL CORP. 510(k) NO: K994139(TRADITIONAL) ATTN: LARRY R PILOT PHONE NO : 202-496-7561 1900 K STREET, N.W. SE DECISION MADE: 23-JUN-00 WASHINGTON, DC 20006-1108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TEARAWAY INTRODUCER SHEATH XENTEK MEDICAL, INC. 510(k) NO: K000313(TRADITIONAL) ATTN: JIM EDDINGS PHONE NO : 903-675-1429 6136 FM 1616 SE DECISION MADE: 16-JUN-00 ATHENS, TX 75751 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEROGEL OTOLOGIC PACK XOMED, INC. 510(k) NO: K001148(TRADITIONAL) ATTN: DAVE TIMLIN PHONE NO : 904-279-7532 6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 03-JUN-00 JACKSONVILLE, FL 32216 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICRO-FRANCE TROCARS AND ACCESSORIES XOMED, INC. 510(k) NO: K993653(TRADITIONAL) ATTN: MARTIN D SARGENT PHONE NO : 904-296-9600 6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 09-JUN-00 JACKSONVILLE, FL 32216 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE APTUS, AUTOMATED APPLICATION OF THE GLIADIN IGA ELISA TEST S ZEUS SCIENTIFIC, INC. 510(k) NO: K001393(TRADITIONAL) ATTN: MARK J KOPNITSKY PHONE NO : 908-526-3744 200 EVANS WAY SE DECISION MADE: 07-JUN-00 BRANCHBURG, NJ 08876 510(k) STATEMENT DEVICE: ALLEN MEDULLARY CEMENT PLUGS, ZIMMER POLY PLUG INTRAMEDULLARY SY ZIMMER, INC. 510(k) NO: K001733(TRADITIONAL) ATTN: FRED MCCLURE PHONE NO : 219-372-4294 P.O. BOX 708 SE DECISION MADE: 20-JUN-00 WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 294 TOTAL WITH SUMMARIES 213 TOTAL WITH STATEMENTS 81
Updated 7/18/2000
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