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Medical Devices
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June 2000 510(k) Clearances
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE)
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD 01-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
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