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510(k)s Final Decisions Rendered for May 1999 |
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DEVICE: ALBUMIN BCG, MODEL AL 103-01
A.P. TOTAL CARE, INC. 510(k) NO: K990978(TRADITIONAL)
ATTN: LUIS P LEON PHONE NO : 203-335-9277
70 HAWLEY AVE, SE DECISION MADE: 25-MAY-99
PO BOX 6216 510(k) STATEMENT
BRIDGEPORT, CT
DEVICE: BUN, MODEL BU 104-01
A.P. TOTAL CARE, INC. 510(k) NO: K990980(TRADITIONAL)
ATTN: LUIS P LEON PHONE NO : 203-335-9277
70 HAWLEY AVE, SE DECISION MADE: 25-MAY-99
PO BOX 6216 510(k) STATEMENT
BRIDGEPORT, CT
DEVICE: GLUCOSE, HEXOKINASE (R1), MODEL GL101-01, GLUCOSE HEXOKINASE (R
A.P. TOTAL CARE, INC. 510(k) NO: K990981(TRADITIONAL)
ATTN: LUIS P LEON PHONE NO : 203-335-9277
70 HAWLEY AVE, SE DECISION MADE: 25-MAY-99
PO BOX 6216 510(k) STATEMENT
BRIDGEPORT, CT
DEVICE: CARBON DIOXIDE (CO2), PRODUCT NO. CC0107-01
A.P. TOTAL CARE, INC. 510(k) NO: K991108(TRADITIONAL)
ATTN: LUIS P LEON PHONE NO : 203-335-9277
70 HAWLEY AVE, SE DECISION MADE: 25-MAY-99
PO BOX 6216 510(k) STATEMENT
BRIDGEPORT, CT
DEVICE: CREATININE REAGENT, PRODUCT NO CR105-01, CREATININE REAGENT, PRO
A.P. TOTAL CARE, INC. 510(k) NO: K991109(TRADITIONAL)
ATTN: LUIS P LEON PHONE NO : 203-335-9277
70 HAWLEY AVE, SE DECISION MADE: 25-MAY-99
PO BOX 6216 510(k) STATEMENT
BRIDGEPORT, CT
DEVICE: BUFFER CHROMOGEN (R1), PRODUCT NO. CA110-01, EDTA REAGEN (R2), P
A.P. TOTAL CARE, INC. 510(k) NO: K991111(TRADITIONAL)
ATTN: LUIS P LEON PHONE NO : 203-335-9277
70 HAWLEY AVE, SE DECISION MADE: 25-MAY-99
PO BOX 6216 510(k) STATEMENT
BRIDGEPORT, CT
DEVICE: TOTAL IRON, MODELS FE 109-01, FE 109-02
A.P. TOTAL CARE, INC. 510(k) NO: K991244(TRADITIONAL)
ATTN: LUIS P LEON PHONE NO : 203-335-9277
70 HAWLEY AVE, SE DECISION MADE: 25-MAY-99
PO BOX 6216 510(k) STATEMENT
BRIDGEPORT, CT
DEVICE: URIC ACID, MODEL UA112-01
A.P. TOTAL CARE, INC. 510(k) NO: K991247(TRADITIONAL)
ATTN: LUIS P LEON PHONE NO : 203-335-9277
70 HAWLEY AVE, SE DECISION MADE: 25-MAY-99
PO BOX 6216 510(k) STATEMENT
BRIDGEPORT, CT 06606
DEVICE: WALKCARE P200 SYSTEM
A.STEIN-REGULATORY AFFAIRS CONSULT510(k) NO: K973592(TRADITIONAL)
ATTN: AHAVA STEIN PHONE NO : 972 979 20673
P.O.B. 454 SE DECISION MADE: 20-MAY-99
GINOT SHOMRON, ISRAEL 44853 510(k) STATEMENT
DEVICE: ABBOTT ARCHITECT CEA
ABBOTT LABORATORIES, INC. 510(k) NO: K990774(TRADITIONAL)
ATTN: KAREN L GATES PHONE NO : 847-938-0538
200 ABBOTT PARK ROAD SE DECISION MADE: 11-MAY-99
ABBOTT PARK, IL 60064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ALCYON DIRECT BILIRUBIN
ABBOTT LABORATORIES, INC. 510(k) NO: K991175(TRADITIONAL)
ATTN: MARK LITTLEFIELD PHONE NO : 972-518-6062
1920 HURD DR. SE DECISION MADE: 28-MAY-99
IRVING, TX 75038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCLAIM INFUSION PUMP
ABBOTT LABORATORIES, INC. 510(k) NO: K991501(SPECIAL)
ATTN: JILL SACKETT PHONE NO : 847-937-4085
200 ABBOTT PARK ROAD SE DECISION MADE: 13-MAY-99
ABBOTT PARK, IL 60064 510(k) STATEMENT
DEVICE: FAMOUS PHYSICIANS BRAND DISPOSABLE ACUPUNCTURE NEEDLES
ACC INTL. 510(k) NO: K990729(TRADITIONAL)
ATTN: ARTHUR K.K. MA PHONE NO : 626-573-9220
108 N. YNEZ AVE SE DECISION MADE: 13-MAY-99
SUITE 128 510(k) STATEMENT
MONTEREY PARK, CA 91754
DEVICE: FLEXNEEDLE PLUS
ACT MEDICAL, INC. 510(k) NO: K990693(TRADITIONAL)
ATTN: WENDY V SHOTTS PHONE NO : 617-964-9100
150 CALIFORNIA ST. SE DECISION MADE: 14-MAY-99
NEWTON, MA 02458 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVENTURE TINTS, COLOR ENHANCED TINTED SOFT CONTACT LENS
ADVENTURE IN COLORS, INC. 510(k) NO: K984098(TRADITIONAL)
ATTN: MARTIN DALSING PHONE NO : 970-243-5490
623 GLACIER DRIVE SE DECISION MADE: 10-MAY-99
GRAND JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER
ALCON LABORATORIES 510(k) NO: K990480(TRADITIONAL)
ATTN: RALPH H LARSEN PHONE NO : 817-551-4702
6201 SOUTH FREEWAY SE DECISION MADE: 10-MAY-99
FORT WORTH, TX 76134-2099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AII-PRO 100 PLUS AND ALL-PRO 200
ALL-PRO IMAGING CORP. 510(k) NO: K991435(TRADITIONAL)
ATTN: FREDERICK R FISCHER PHONE NO : 516-433-7676
70 CANTIAGUE ROCK RD. SE DECISION MADE: 20-MAY-99
HICKSVILLE, NY 11801 510(k) STATEMENT
DEVICE: AIRLIFE BUBBLE HUMIDIFER, MODEL 002003 AND 002006
ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K991484(SPECIAL)
ATTN: SHARON ROBBINS PHONE NO : 847-785-3311
1500 WAUKEGAN RD., MPWM SE DECISION MADE: 13-MAY-99
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLEXIBLE VASCULAR CLAMP, VERSION 2
ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K991589(SPECIAL)
ATTN: PATRICIA SHARPE-GREGG PHONE NO : 847-578-3636
1500 WAUKEGAN RD. SE DECISION MADE: 18-MAY-99
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACID CONCENTRATE AND POWDER, ACETATE CONCENTRATE LIQUID AND POWD
ALTHIN BIOPHARM, INC. 510(k) NO: K990507(TRADITIONAL)
ATTN: JEAN SAURIOL PHONE NO : 450 662 2211
3885 INDUSTRIAL BLVD. SE DECISION MADE: 07-MAY-99
LAVAL, QUEBEC, CANADA H7L 4S3 510(k) STATEMENT
DEVICE: PULSEMASTER DENTAL LASER SYSTEM
AMERICAN DENTAL TECHNOLOGIES, INC.510(k) NO: K984486(TRADITIONAL)
ATTN: JOHN G SULEWSKI PHONE NO : 248-395-3900
18860 WEST TEN MILE ROAD SE DECISION MADE: 13-MAY-99
SOUTHFIELD, MI 48075-2657 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BQ/BM INTEGRATED LASER DELIVERY SYSTEM
AMERICAN LASER CORP. 510(k) NO: K990665(TRADITIONAL)
ATTN: DANIEL HOEFER PHONE NO : 801-972-1311
2417 SOUTH 3850 WEST SE DECISION MADE: 17-MAY-99
SALT LAKE CITY, UT 84120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DBEST OCCULT BLOOD TEST KIT
AMERITEK, INC. 510(k) NO: K984269(TRADITIONAL)
ATTN: K C YEE PHONE NO : 206-527-5086
7030 35TH AVE., N.E. SE DECISION MADE: 11-MAY-99
SEATTLE, WA 98115 510(k) STATEMENT
DEVICE: ATLAST GLUCOSE CONTROL SOLUTION
AMIRA MEDICAL, INC. 510(k) NO: K991075(TRADITIONAL)
ATTN: NINA PELED PHONE NO : 831-440-5448
4742 SCOTTS VALLEY DR. SE DECISION MADE: 10-MAY-99
SCOTTS VALLEY, CA 95066 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM
AMPRI RUBBERWARE INDUSTRIES SDN BH510(k) NO: K990812(TRADITIONAL)
ATTN: PACK LOON TANG PHONE NO : 603 807 3778
LOT B5 & B6, PHASE II, SE DECISION MADE: 04-MAY-99
KAWASAN PERINDUSTRIAN MIEL 510(k) STATEMENT
BATANG KALI, SELANGOR, MALAYSIA 44300
DEVICE: PRE POWDERED LATEX EXAMINATION GLOVES
APL PRODUCTS SDN. BHD. 510(k) NO: K990879(TRADITIONAL)
ATTN: SON HONG LEE PHONE NO : 605 672 3152
LOT 8961 & 8964, BATU 19 SE DECISION MADE: 17-MAY-99
JALAN BRUAS 510(k) STATEMENT
AYER TAWAR, MALAYSIA 32400
DEVICE: POWDER FREE LATEX EXAMINATION GLOVES
APL PRODUCTS SDN. BHD. 510(k) NO: K990901(TRADITIONAL)
ATTN: SON HONG LEE PHONE NO : 605 672 3152
LOT 8961 & 8964, BATU 19 SE DECISION MADE: 04-MAY-99
JALAN BRUAS 510(k) STATEMENT
AYER TAWAR, MALAYSIA 32400
DEVICE: APPLIED BIOTECH SURESTEP DRUG SCREEN MULTI TEST
APPLIED BIOTECH, INC. 510(k) NO: K990616(TRADITIONAL)
ATTN: JAMES TUNG PHONE NO : 619-587-6771
10237 FLANDERS CT. SE DECISION MADE: 04-MAY-99
SAN DIEGO, CA 92121 510(k) STATEMENT
DEVICE: APPLIED BIOTECH SURESTEP H. PYLORI WB
APPLIED BIOTECH, INC. 510(k) NO: K990892(TRADITIONAL)
ATTN: JAMES TUNG PHONE NO : 619-587-6771
10237 FLANDERS CT. SE DECISION MADE: 19-MAY-99
SAN DIEGO, CA 92121 510(k) STATEMENT
DEVICE: CYSTIC DUCT BALLOON DILATING CATHETER
APPLIED MEDICAL RESOURCES 510(k) NO: K983154(TRADITIONAL)
ATTN: HOWARD V ROWE PHONE NO : 949-582-6120
26051 MERIT CIRCLE, #104 SE DECISION MADE: 05-MAY-99
LAGUNA HILLS, CA 92653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT
ARROW INTL., INC. 510(k) NO: K984022(TRADITIONAL)
ATTN: THOMAS D NICKEL PHONE NO : 610-378-0131
2400 BERNVILLE RD. SE DECISION MADE: 18-MAY-99
READING, PA 19605 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR "PTD", MODE
ARROW INTL., INC. 510(k) NO: K990829(SPECIAL)
ATTN: THOMAS D NICKEL PHONE NO : 610-478-3137
2400 BERNVILLE RD. SE DECISION MADE: 04-MAY-99
READING, PA 19605 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT
ARROW INTL., INC. 510(k) NO: K991431(SPECIAL)
ATTN: THOMAS D NICKEL PHONE NO : 610-478-3137
2400 BERNVILLE RD. SE DECISION MADE: 26-MAY-99
READING, PA 19605 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS
ASAHI MEDICAL CO., LTD. 510(k) NO: K983720(TRADITIONAL)
ATTN: DAVID L WEST PHONE NO : 301-548-0504
15825 SHADY GROVE ROAD, SE DECISION MADE: 17-MAY-99
SUITE 90 510(k) SUMMARY AVAILABLE FROM FDA
ROCKVILLE, MD 20850
DEVICE: ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K
ASTORIA-PACIFIC,INC. 510(k) NO: K990957(TRADITIONAL)
ATTN: RAYMOND L PAVITT PHONE NO : 503-657-3010
14600 S.E. 82ND DR. SE DECISION MADE: 11-MAY-99
CLAKAMAS, OR 97015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAIN
ATRIUM MEDICAL CORP. 510(k) NO: K984496(TRADITIONAL)
ATTN: JOSEPH P DEPAOLO PHONE NO : 603-880-1433
5 WENTWORTH DR. SE DECISION MADE: 05-MAY-99
HUDSON, NH 03051 510(k) STATEMENT
DEVICE: BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME
BALLARD MEDICAL PRODUCTS 510(k) NO: K990376(TRADITIONAL)
ATTN: E. MARTIN CHAMBERLAIN PHONE NO : 801-572-6800
12050 LONE PEAK PKWY. SE DECISION MADE: 03-MAY-99
DRAPER, UT 84020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARRIERPLUS SYNTHETIC POWDER-FREE SURGICAL GLOVES
BARRIERMED GLOVE CO. 510(k) NO: K990710(TRADITIONAL)
ATTN: CARLO PONCIPE PHONE NO : 407-323-1604
2500 WEST LAKE MARY BLVD. SE DECISION MADE: 20-MAY-99
LAKE MARY, FL 32746 510(k) STATEMENT
DEVICE: THE IMMUNO 1 CA 125 II ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN V
BAYER CORP. 510(k) NO: K983715(TRADITIONAL)
ATTN: GABRIEL J MURACA, JR. PHONE NO : 914-524-3494
511 BENEDICT AVE. SE DECISION MADE: 14-MAY-99
TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAYER ADVIA 1650 CHEMISTRY SYSTEM
BAYER CORP. 510(k) NO: K990346(TRADITIONAL)
ATTN: GABRIEL J MURACA, JR. PHONE NO : 914-524-3494
511 BENEDICT AVE. SE DECISION MADE: 21-MAY-99
TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARRAY 360 SYSTEM C-REACTIVE PROTEIN (CRP MPE) REAGENT
BECKMAN COULTER, INC. 510(k) NO: K990704(TRADITIONAL)
ATTN: ANNETTE HELLIE PHONE NO : 714-993-8767
200 SOUTH KRAEMER BLVD.,W-337 SE DECISION MADE: 03-MAY-99
BREA, CA 92822-8000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FALCON IVF FOUR WELL PLATE
BECTON DICKINSON LABWARE 510(k) NO: K991249(TRADITIONAL)
ATTN: DAVID BALL PHONE NO : 408-954-2694
1 BECTON DR. SE DECISION MADE: 05-MAY-99
FRANKLIN LAKES, NJ 07465-1886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FALCON IVF ONE WELL DISH
BECTON DICKINSON LABWARE 510(k) NO: K991251(TRADITIONAL)
ATTN: DAVID BALL PHONE NO : 408-954-2694
1 BECTON DR. SE DECISION MADE: 05-MAY-99
FRANKLIN LAKES, NJ 07465-1886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FALCON IVF ROUND DISH
BECTON DICKINSON LABWARE 510(k) NO: K991253(TRADITIONAL)
ATTN: DAVID BALL PHONE NO : 408-954-2694
1 BECTON DR. SE DECISION MADE: 05-MAY-99
FRANKLIN LAKES, NJ 07465-1886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION
BECTON DICKINSON VACUTAINER SYSTEM510(k) NO: K991088(TRADITIONAL)
ATTN: ANDREA HRONCICH PHONE NO : 201-847-6173
ONE BECTON DR. SE DECISION MADE: 28-MAY-99
FRANKLIN LAKES, NJ 07417-1885 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VACUTAINER BRAND CTAD TUBE (MULTIPLE)
BECTON DICKINSON VACUTAINER SYSTEM510(k) NO: K991120(TRADITIONAL)
ATTN: JAMES W HAYNES PHONE NO : 201-847-5170
1 BECTON DR. SE DECISION MADE: 19-MAY-99
FRANKLIN LAKES, NJ 07417-1885 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHROMOPHARE D500, D530, D650
BERCHTOLD GMBH & CO. 510(k) NO: K991527(SPECIAL)
ATTN: WOLFRAM K HILL PHONE NO : 004 974 61181370
LUDWIGSTALER STR. 25 SE DECISION MADE: 27-MAY-99
TUTTLINGEN, GERMANY D-78505 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION OF:BIODERM FOAM WOUND DRESSING
BIODERM, INC. 510(k) NO: K990955(TRADITIONAL)
ATTN: GEORGE WORTHLEY PHONE NO : 630-690-8339
P.O. BOX 4882 SE DECISION MADE: 18-MAY-99
WHEATON, IL 60189 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BONE MULCH SCREW SYSTEM
BIOMET, INC. 510(k) NO: K991298(TRADITIONAL)
ATTN: FRED MCCLURE PHONE NO : 219-372-1568
AIRPORT INDUSTRIAL PARK SE DECISION MADE: 14-MAY-99
WARSAW, IN 46580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASCENT KNEE SYSTEM
BIOMET, INC. 510(k) NO: K991428(SPECIAL)
ATTN: DALENE HUFZIGER BINKLEY PHONE NO : 219-267-6639
P.O. BOX 587 SE DECISION MADE: 21-MAY-99
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E-SCAN
BIOSOUND ESAOTE, INC. 510(k) NO: K990968(TRADITIONAL)
ATTN: COLLEEN HITTLE PHONE NO : 317-849-1793
8000 CASTLEWAY DR. SE DECISION MADE: 27-MAY-99
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VECTORVISION2
BRAINLAB GMBH 510(k) NO: K983831(TRADITIONAL)
ATTN: PHONE NO :
3100 HANSEN WAY SE DECISION MADE: 19-MAY-99
BUILDING 4A, MAILSTOP E233 510(k) STATEMENT
PALO ALTO, CA 94304
DEVICE: BRAINMASTER 2E MODULE AND SOFTWARE BIOFEEDBACK DEVICE
BRAINMASTER 510(k) NO: K990538(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 19-MAY-99
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDER FREE)
BRIGHTWAY HOLDINGS SDN. BHD. 510(k) NO: K990878(TRADITIONAL)
ATTN: G. BASKARAN PHONE NO : 603 343 1007
LOT 1559, JALAN ISTIMEWA SE DECISION MADE: 21-MAY-99
BATU BELAH, KLANG 510(k) STATEMENT
SELANGOR DARUL EHSAN, MALAYSIA 42100
DEVICE: TITANIUM VOCAL FOLD MEDIALIZING IMPLANT, MODELS 5001 001 (FEMAL
BUSINESS SUPPORT INTL. 510(k) NO: K991324(TRADITIONAL)
ATTN: DAGMAR S MASER PHONE NO : 011 312 04289591
AMSTEL 320-I SE DECISION MADE: 18-MAY-99
AMSTERDAM, NETHERLANDS 1017-AP 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRACER O-T-W MAPPING DEVICE
CARDIMA, INC. 510(k) NO: K972803(TRADITIONAL)
ATTN: SHELLEY TRIMM PHONE NO : 510-354-0300
47266 BENICIA ST. SE DECISION MADE: 11-MAY-99
FREMONT, CA 94538-1372 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TAS ANALYZER, MODEL 1009
CARDIOVASCULAR DIAGNOSTICS, INC. 510(k) NO: K990566(TRADITIONAL)
ATTN: PETER SCOTT PHONE NO : 919-874-6103
5301 DEPARTURE DR. SE DECISION MADE: 14-MAY-99
RALEIGH, NC 27616 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
COBE CARDIOVASCULAR, INC. 510(k) NO: K990239(TRADITIONAL)
ATTN: LYNNE LEONARD PHONE NO : 303-467-6586
14401 WEST 65TH WAY SE DECISION MADE: 25-MAY-99
ARVADA, CO 80004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVUS VERDI DELIVERY SYSTEMS
COHERENT, INC. 510(k) NO: K991258(TRADITIONAL)
ATTN: KATHY A MAYNOR PHONE NO : 408-764-3266
2400 CONDENSA ST. SE DECISION MADE: 13-MAY-99
SANTA CLARA, CA 95051-0901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEOGRAM BONE DENSITOMETER
COMPUMED, INC. 510(k) NO: K984285(TRADITIONAL)
ATTN: T WHIT ATHEY PHONE NO : 301-770-9590
12300 TWINBROOK PARKWAY SE DECISION MADE: 19-MAY-99
SUITE 625 510(k) SUMMARY AVAILABLE FROM FDA
ROCKVILLE, MD 20852
DEVICE: MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER
COMPUTER MOTION, INC. 510(k) NO: K991635(SPECIAL)
ATTN: DAVID U THOMAS PHONE NO : 805-685-3729
130 CREMONA DRIVE, SUITE B SE DECISION MADE: 27-MAY-99
GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONMED ABC PROBE FOR FLEXIBLE ENDOSCOPES
CONMED CORP. 510(k) NO: K990586(TRADITIONAL)
ATTN: IRA D DUESLER PHONE NO : 315-797-8375
310 BROAD ST. SE DECISION MADE: 17-MAY-99
UTICA, NY 13501-1203 510(k) STATEMENT
DEVICE: CONTINENTAL 45 TORIC SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY
CONTINENTAL SOFT LENS, INC. 510(k) NO: K990011(TRADITIONAL)
ATTN: KIM MCQUARRIE PHONE NO : 303-795-2130
10 GLENVIEW DR. SE DECISION MADE: 11-MAY-99
LITTLETON, CO 80123 510(k) STATEMENT
DEVICE: SIGNADRESS DUODERM DRESSING
CONVATEC, A DIVISION OF E.R. SQUIB510(k) NO: K990964(TRADITIONAL)
ATTN: NANCY L WOLLEY PHONE NO : 908-281-2571
100 HEADQUARTERS PARK DRIVE SE DECISION MADE: 18-MAY-99
SKILLMAN, NJ 08558 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER
COOK, INC. 510(k) NO: K990753(TRADITIONAL)
ATTN: APRIL LAVENDER PHONE NO : 812-339-2235
925 SOUTH CURRY PIKE SE DECISION MADE: 27-MAY-99
BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORDIS TEMPO ANGIOGRAPHY CATHETER
CORDIS CORP. 510(k) NO: K991673(SPECIAL)
ATTN: ARIEL MACTAVISH PHONE NO : 305-824-2332
14201 N.W. 60TH AVE. SE DECISION MADE: 26-MAY-99
MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COULTER Z2 ANALYZER
COULTER CORP. 510(k) NO: K991070(TRADITIONAL)
ATTN: THOMAS J ENGLISH PHONE NO : 305-380-4331
1950 WEST 8TH AVE. SE DECISION MADE: 11-MAY-99
HIALEAH, FL 33010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION OF N/T PROTEIN CONTROL SL
DADE BEHRING, INC. 510(k) NO: K991182(TRADITIONAL)
ATTN: CAROLYN K GEORGE PHONE NO : 781-826-2073
P.O. BOX 6101 SE DECISION MADE: 19-MAY-99
NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
DADE MICROSCAN, INC. 510(k) NO: K983408(TRADITIONAL)
ATTN: SHAROLYN J LENTSCH PHONE NO : 916-374-3183
1584 ENTERPRISE BLVD. SE DECISION MADE: 10-MAY-99
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR
DANEK MEDICAL, INC. 510(k) NO: K991528(SPECIAL)
ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PL. SE DECISION MADE: 28-MAY-99
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR, MODEL # 0998-
DATASCOPE CORP. 510(k) NO: K983575(TRADITIONAL)
ATTN: RUSSELL OLSEN PHONE NO : 201-967-6894
580 WINTERS AVE. SE DECISION MADE: 13-MAY-99
PARAMUS, NJ 07653 510(k) STATEMENT
DEVICE: STARDENTAL AXCS STERILE WATER SYSTEM
DEN-TAL-EZ, INC. 510(k) NO: K990844(TRADITIONAL)
ATTN: FRANK OELLIG PHONE NO : 717-291-1161
1816 COLONIAL VILLAGE LN. SE DECISION MADE: 28-MAY-99
LANCASTER, PA 17601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DMD DIGITAL X-RAY SYSTEM
DENTAL/MEDICAL DIAGNOSTIC SYSTEMS,510(k) NO: K990087(TRADITIONAL)
ATTN: STEVE BRODY PHONE NO : 949-756-1770
16722 MILLIKAN AVE. SE DECISION MADE: 13-MAY-99
IRVINE, CA 92606 510(k) STATEMENT
DEVICE: MANOMETRIC ASSEMBLIES
DENTSLEEVE PTY., LTD. 510(k) NO: K983665(TRADITIONAL)
ATTN: MARCUS TIPPETT PHONE NO : 618 827 10744
56 A/B GLEN OSMOND RD. SE DECISION MADE: 17-MAY-99
PARKSIDE, SOUTH AUSTRALIA, AUSTRAL510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSING
DERMAPHYLYX, INC. 510(k) NO: K990875(TRADITIONAL)
ATTN: ANDREW M REED PHONE NO : 303-431-6796
12106, WEST 75TH LANE SE DECISION MADE: 27-MAY-99
ARVADA, CO 80005-5306 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DERMAPHYLYX HYDROCOLLOID WOUND DRESSING, HEALIAN HYDROCOLLOID WO
DERMAPHYLYX, INC. 510(k) NO: K990891(TRADITIONAL)
ATTN: ANDREW M REED PHONE NO : 303-431-6796
12106, WEST 75TH LANE SE DECISION MADE: 27-MAY-99
ARVADA, CO 80005-5306 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PELVX INCONTINENCE DISH, MODEL 301-306
DESCHUTES MEDICAL PRODUCTS, INC. 510(k) NO: K990593(TRADITIONAL)
ATTN: DENISE BESTWICK PHONE NO : 541-385-0350
1011 S.W. EMKAY DR., SUITE 104 SE DECISION MADE: 24-MAY-99
BEND, OR 97702 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMULITE 2000 ANTI-TG AB, MODEL L2KTG2, L2KTG6
DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K991094(SPECIAL)
ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200
5700 WEST 96TH ST. SE DECISION MADE: 13-MAY-99
LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMULITE 2000 ANTI-TPO AB, MODEL L2KT02, L2KT06
DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K991096(SPECIAL)
ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200
5700 WEST 96TH ST. SE DECISION MADE: 13-MAY-99
LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COPALIS EBV-M ANTIBODY ASSAY
DIASORIN INC. 510(k) NO: K991459(TRADITIONAL)
ATTN: JUDITH J SMITH PHONE NO : 651-439-9710
9175 GUIFORD ROAD SE DECISION MADE: 14-MAY-99
COLUMBIA, MD 21046 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IONOSIT BOND
DMG CHEMISCH PHARMAZEUTISCHE FABRI510(k) NO: K991172(TRADITIONAL)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552
5 WHITCOMB AVENUE SE DECISION MADE: 17-MAY-99
AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTIPLE-BRAND MALE LATEX CONDOM (LUBRICATED WITH NONOXYNOL-9)
DONGKUK TECHCO RUBBER INDUSTRIES S510(k) NO: K990669(ABBREVIATED)
ATTN: PETER PARK PHONE NO : 604 261 0600
7TH FL. MAYBAN TRUST BLDG. SE DECISION MADE: 17-MAY-99
3 PENANG ST. 510(k) STATEMENT
PENANG, MALAYSIA 10200
DEVICE: EASTGATE PERSONAL MONITOR
EASTGATE TRADING CORP. 510(k) NO: K990731(TRADITIONAL)
ATTN: MORRIS CORN PHONE NO : 212-947-8388
990 AVE. OF AMERICAS, #15D SE DECISION MADE: 19-MAY-99
NEW YORK, NY 10084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EDGE SYSTEMS STERILE TUBING
EDGE SYSTEMS CORP. 510(k) NO: K990748(TRADITIONAL)
ATTN: GARY MOCNIK PHONE NO : 949-363-2953
30001 GOLDEN LANTERN # 334 SE DECISION MADE: 04-MAY-99
LAGUNA NIGUEL, CA 92677 510(k) STATEMENT
DEVICE: ELAN ALKALINE PHOSPHATE REAGENT KIT
ELAN HOLDINGS, INC. 510(k) NO: K991387(TRADITIONAL)
ATTN: RALPH BOLSTAD PHONE NO : 800-733-4424
231 NORTH PUENTE ST. SE DECISION MADE: 19-MAY-99
BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEKSELL GAMMA KNIFE TARGET SYSTEM, MODEL 24001
ELEKTA INSTRUMENT AB 510(k) NO: K984328(TRADITIONAL)
ATTN: CAROL PATTERSON PHONE NO : 619-451-0642
18140 SMOKESIGNAL DRIVE SE DECISION MADE: 21-MAY-99
SAN DIEGO, CA 92127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MILLENNIUM
ENDO TECHNIC CORP. 510(k) NO: K990908(TRADITIONAL)
ATTN: ANDREW I KIMMEL PHONE NO : 949-361-3545
981 CALLE AMANECER SE DECISION MADE: 27-MAY-99
(MOVED FROM BOS/DO TO LA/DOS) 510(k) SUMMARY AVAILABLE FROM FDA
SAN CLEMENTE, CA 92680
DEVICE: VITRON M
ESPE DENTAL AG 510(k) NO: K990763(TRADITIONAL)
ATTN: ANDREAS PETERMANN PHONE NO : 011 498 1527001395
ESPE PLATZ SE DECISION MADE: 25-MAY-99
SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITRON H
ESPE DENTAL AG 510(k) NO: K991220(TRADITIONAL)
ATTN: ANDREAS PETERMANN PHONE NO : 498 152 7001395
ESPE PLATZ SE DECISION MADE: 20-MAY-99
SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VESTOGUM
ESPE DENTAL AG 510(k) NO: K991221(TRADITIONAL)
ATTN: ANDREAS PETERMANN PHONE NO : 498 152 7001395
ESPE PLATZ SE DECISION MADE: 20-MAY-99
SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES
ETHICON ENDO-SURGERY, INC. 510(k) NO: K991030(TRADITIONAL)
ATTN: EDWIN O BILLIPS PHONE NO : 513-786-7162
4545 CREEK ROAD SE DECISION MADE: 17-MAY-99
CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GALLINI ATRA-CUT NEEDLE
GALLINI U.S., LLC 510(k) NO: K990645(TRADITIONAL)
ATTN: PAUL L HAWTHORNE PHONE NO : 804-261-1601
3991 GLENSIDE DR., SUITE F SE DECISION MADE: 19-MAY-99
RICHMOND, VA 23229 510(k) STATEMENT
DEVICE: GALLINI BYCUT NEEDLE
GALLINI U.S., LLC 510(k) NO: K990716(TRADITIONAL)
ATTN: PAUL L HAWTHORNE PHONE NO : 804-261-1601
3991 GLENSIDE DR., SUITE F SE DECISION MADE: 17-MAY-99
RICHMOND, VA 23229 510(k) STATEMENT
DEVICE: GC RELINE SOFT/EXTRA SOFT
GC AMERICA, INC. 510(k) NO: K990736(TRADITIONAL)
ATTN: TERRY L JORITZ PHONE NO : 708-587-0900
3737 WEST 127TH STREET SE DECISION MADE: 28-MAY-99
ALSIP, IL 60803 510(k) STATEMENT
DEVICE: 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM
GE MEDICAL SYSTEMS, INC. 510(k) NO: K990550(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 414-544-3894
P.O. BOX 414, W-709 SE DECISION MADE: 11-MAY-99
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCY
GERMAINE LABORATORIES, INC. 510(k) NO: K991369(TRADITIONAL)
ATTN: MARTIN O'CONNOR PHONE NO : 210-692-4192
4203 GARDENDALE CENTER, #230 SE DECISION MADE: 10-MAY-99
SAN ANTONIO, TX 78229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LATEX EXAMINATION GLOVES POWDERED, LOW PROTEIN
GLOVCO (M) SDN. BHD. 510(k) NO: K991043(TRADITIONAL)
ATTN: TAN PENG HOCK PHONE NO : 603 391 3888
LOT 760, JALAN HAJI SIRAT, SE DECISION MADE: 04-MAY-99
OFF JALAN MERU 510(k) STATEMENT
KLANG, SELANGOR D.E., MALAYSIA 42100
DEVICE: STAPES PROSTHESES
GRACE MEDICAL, INC. 510(k) NO: K991394(SPECIAL)
ATTN: ANTHONY D PRESCOTT PHONE NO : 901-386-0990
7731 HIGHWAY 70, SUITE 107 SE DECISION MADE: 18-MAY-99
BARTLETT, TN 38133 510(k) STATEMENT
DEVICE: GREAT SMOKIES INTESTINAL PERMABILITY TEST SYSTEM
GREAT SMOKIES DIAGNOSTIC LABORATOR510(k) NO: K991156(TRADITIONAL)
ATTN: STEPHEN BARRIE PHONE NO : 800-522-4762
63 ZILLICOA ST. SE DECISION MADE: 28-MAY-99
ASHEVILLE, NC 28801-1074 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHO-GLOW GLITTER
HARRY J. BOSWORTH CO. 510(k) NO: K990699(TRADITIONAL)
ATTN: MILDRED M GOLDSTEIN PHONE NO : 847-679-3400
7227 NORTH HAMLIN AVE. SE DECISION MADE: 17-MAY-99
SKOKIE, IL 60076 510(k) STATEMENT
DEVICE: SMARTPREP CENTRIFUGE SYSTEM
HARVEST TECHNOLOGIES, LLC 510(k) NO: K991430(TRADITIONAL)
ATTN: RICK LARIVIERE PHONE NO : 781-982-1900
77 ACCORD PARK DR., D-7 SE DECISION MADE: 28-MAY-99
NORWELL, MA 02061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLOW LINE
HERAEUS KULZER, INC. 510(k) NO: K990756(TRADITIONAL)
ATTN: CHERYL V ZIMMERMAN PHONE NO : 219-299-6662
4315 SOUTH LAFAYETTE BLVD. SE DECISION MADE: 07-MAY-99
SOUTH BEND, IN 46614-2517 510(k) STATEMENT
DEVICE: HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERA SYSTEM WITH THICK NA
HITACHI MEDICAL CORP. OF AMERICA 510(k) NO: K991129(TRADITIONAL)
ATTN: GARY W ENOS PHONE NO : 330-405-3330
9177 DUTTON DR. SE DECISION MADE: 13-MAY-99
TWINSBURG, OH 44056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HITACHI VERSIFLEX
HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K991231(TRADITIONAL)
ATTN: T. WHIT ATHEY PHONE NO : 301-770-9590
12300 TWINBROOK PARKWAY, SE DECISION MADE: 24-MAY-99
SUITE 625 510(k) SUMMARY AVAILABLE FROM FDA
ROCKVILLE, MD 20852
DEVICE: OSTEONICS SCORPIO TOTAL KNEE RELAXED BACK P/S TIBIAL BEARING INS
HOWMEDICA OSTEONICS CORP. 510(k) NO: K991461(SPECIAL)
ATTN: MARYBETH NAUGHTON PHONE NO : 201-934-4376
59 ROUTE 17 SE DECISION MADE: 17-MAY-99
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SHIELD
HURRICANE MEDICAL 510(k) NO: K990671(TRADITIONAL)
ATTN: DAVID A CLAPP PHONE NO : 941-751-0588
2331K 63RD AVE. EAST SE DECISION MADE: 10-MAY-99
BRADENTON, FL 34203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LACRIMAL INTUBATION SET, DACRYOCYSTORHINOSTOMY (DCR) SET
HURRICANE MEDICAL 510(k) NO: K990672(TRADITIONAL)
ATTN: DAVID A CLAPP PHONE NO : 941-751-0588
2331K 63RD AVE. EAST SE DECISION MADE: 18-MAY-99
BRADENTON, FL 34203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERACOUSTICS AT22T AUTOMATIC IMPEDANCE AUDIOMETER
IDEM (INT'L DIST. OF ELECTRONICS F510(k) NO: K990585(TRADITIONAL)
ATTN: DONNA WARD PHONE NO : 800-947-6334
4814 EAST SECOND STREET SE DECISION MADE: 17-MAY-99
BENICIA, CA 94510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER
IDEM (INT'L DIST. OF ELECTRONICS F510(k) NO: K990652(TRADITIONAL)
ATTN: DONNA WARD PHONE NO : 800-947-6334
4814 EAST SECOND STREET SE DECISION MADE: 17-MAY-99
BENICIA, CA 94510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRANSFX INTERMEDIATE EXTERNAL FIXATION SYSTEM,TRANSFX SMALL EXTE
IMMEDICA, INC. 510(k) NO: K990848(TRADITIONAL)
ATTN: ROY BOGERT PHONE NO : 973-635-9040
100 PASSAIC AVE. SE DECISION MADE: 17-MAY-99
CHATHAM, NJ 07928-2848 510(k) STATEMENT
DEVICE: LAMINOSS DENTAL IMPLANT
IMPLADENT, LTD. 510(k) NO: K982925(TRADITIONAL)
ATTN: MAURICE VALEN PHONE NO : 718-465-1810
198-45 FOOTHILL AVE. SE DECISION MADE: 18-MAY-99
HOLLISWOOD, NY 11423 510(k) STATEMENT
DEVICE: IODINE BRACHYTHERAPY SEEDS, MODEL 3000
IMPLANT SCIENCES CORP. 510(k) NO: K990193(TRADITIONAL)
ATTN: HOWARD L SCHRAYER PHONE NO : 609-924-9510
107 AUDUBON ROAD, #5 SE DECISION MADE: 20-MAY-99
WAKEFIELD, MA 01880-1246 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLIGON FOLEY CATHETER (16 FR) #33816/OLIGON FOLEY CATHETER (18 F
IMPLEMED, INC. 510(k) NO: K990509(ABBREVIATED)
ATTN: ANTHONY L BLANK PHONE NO : 617-923-6375
313 PLEASANT ST. SE DECISION MADE: 18-MAY-99
WATERTOWN, MA 02172 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRIT-SCAN II MONITOR
IN-LINE DIAGNOSTICS CORP. 510(k) NO: K983551(TRADITIONAL)
ATTN: MATTHEW L HAYNIE PHONE NO : 801-451-9000
117 WEST 200 SOUTH SE DECISION MADE: 27-MAY-99
FARMINGTON, UT 84025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSURE PREGNANCY TEST
INBIOS INTL., INC. 510(k) NO: K991515(TRADITIONAL)
ATTN: ESTELA I RAYCHAUDHURI PHONE NO : 206-344-5821
562 1ST. AVE. SOUTH, SUITE 600 SE DECISION MADE: 28-MAY-99
SEATTLE, WA 98104 510(k) STATEMENT
DEVICE: INNERDYNE GENERIC RADIALLY EXPANDING DILATION, G-RED DEVICE
INNERDYNE, INC. 510(k) NO: K990493(TRADITIONAL)
ATTN: RICK GAYKOWSKI PHONE NO : 801-350-3600
5060 WEST AMELIA EARHART DR. SE DECISION MADE: 18-MAY-99
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KERATOME SYSTEM, MODEL K3000
INSIGHT TECHNOLOGIES INSTRUMENTS, 510(k) NO: K984537(TRADITIONAL)
ATTN: CHARLES VASSALLO PHONE NO : 203-876-3481
264 QUARRY ROAD SE DECISION MADE: 14-MAY-99
MILFORD, CT 06460 510(k) STATEMENT
DEVICE: BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL
INTEGRA NEUROCARE LLC 510(k) NO: K981246(TRADITIONAL)
ATTN: LORI HAYS PHONE NO : 800-997-4868
8401 102ND ST., SUITE 200 SE DECISION MADE: 26-MAY-99
PLEASANT PRAIRIE, WI 53158-0390 510(k) STATEMENT
DEVICE: MATHIS VERTEBRAL AND BONE BIOPSY SYSTEM
INTERNATIONAL MEDICAL SYSTEMS 510(k) NO: K990515(TRADITIONAL)
ATTN: PHONE NO :
PO BOX 4936 SE DECISION MADE: 13-MAY-99
ANNAPOLIS, MD 21403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMOCHRON RESPONSE
INTERNATIONAL TECHNIDYNE CORP. 510(k) NO: K983475(TRADITIONAL)
ATTN: JOHN M CLAY PHONE NO : 732-548-5700
8 OLSEN AVENUE SE DECISION MADE: 03-MAY-99
EDISON, NJ 08820 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLATYPUS AV FISTULA NEEDLE PROTECTOR (AVFNP)
ITL CORPORATION, PTY LTD. 510(k) NO: K991404(TRADITIONAL)
ATTN: KENNETH A PALMER PHONE NO : 301-548-0508
15825 SHADY GROVE ROAD SE DECISION MADE: 14-MAY-99
SUITE 90 510(k) SUMMARY AVAILABLE FROM FDA
ROCKVILLE, MD 20850
DEVICE: K-ASSAY CRP CALIBRATOR SET
KAMIYA BIOMEDICAL CO. 510(k) NO: K991210(TRADITIONAL)
ATTN: COLIN GETTY PHONE NO : 206-575-8068
910 INDUSTRY DR. SE DECISION MADE: 11-MAY-99
SEATTLE, WA 98188-3412 510(k) STATEMENT
DEVICE: K-ASSAY CRP
KAMIYA BIOMEDICAL CO. 510(k) NO: K991224(TRADITIONAL)
ATTN: COLIN GETTY PHONE NO : 206-575-8068
910 INDUSTRY DR. SE DECISION MADE: 14-MAY-99
SEATTLE, WA 98188-3412 510(k) STATEMENT
DEVICE: MVM 7.5 FRENCH FLEXIBLE HYSTEROSCOPE
KARL STORZ ENDOSCOPY 510(k) NO: K990411(TRADITIONAL)
ATTN: KEVIN A KENNAN PHONE NO : 310-558-1500
600 CORPORATE POINTE SE DECISION MADE: 11-MAY-99
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CALCITONIN
KMI DIAGNOSTICS, INC. 510(k) NO: K990073(TRADITIONAL)
ATTN: GOTTFRIED KELLERMAN PHONE NO : 715-294-2144
373 280TH STREET SE DECISION MADE: 11-MAY-99
OSCEOLA, WI 54020 510(k) STATEMENT
DEVICE: WARATAH DIGITAL EEG AND SLEEP ACQUISITION DEVICES WITH, OR WITHO
LA MONT MEDICAL, INC. 510(k) NO: K990522(TRADITIONAL)
ATTN: TONY MONTGOMERY PHONE NO : 608-827-9000
555 D'ONOFRIO DR. SE DECISION MADE: 19-MAY-99
MADISON, WI 53719-2053 510(k) STATEMENT
DEVICE: LACTATION TECHNIQUES MODEL B
LACTATION TECHNIQUES INC. 510(k) NO: K981549(TRADITIONAL)
ATTN: MARK LELOUDIS PHONE NO : 801-972-7026
1252 WEST 50 SOUTH SE DECISION MADE: 24-MAY-99
SALT LAKE CITY, UT 84014 510(k) STATEMENT
DEVICE: LAGLOVE BRAND COLORED NITRILE EXAMINATION GLOVES (POWDER FREE)
LAGLOVE (M) SDN. BHD. 510(k) NO: K990882(TRADITIONAL)
ATTN: G. BASKARAN PHONE NO : 603 833 5411
JALAN SIMPANG BALAK, OFF BATU SE DECISION MADE: 21-MAY-99
13, JALAN CHERAS, 43000 KAJANG 510(k) STATEMENT
SELANGOR DARUL EHSAN MALA, MADAGASCAR
DEVICE: QTEXX POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED
LATEXX PARTNERS BHD. 510(k) NO: K991462(TRADITIONAL)
ATTN: CHONG ENG LIM PHONE NO : 605 891 5555
PT. 5054, KAMUNTING IND ESTATE SE DECISION MADE: 28-MAY-99
P.O. BOX 9 510(k) SUMMARY AVAILABLE FROM FDA
KAMUNTING, PERAK, MALAYSIA 34600
DEVICE: LIFE IMAGING SYSTEMS, MODEL L3DI
LIFE IMAGING SYSTEMS, INC. 510(k) NO: K990560(TRADITIONAL)
ATTN: KEVIN MORNINGSTAR PHONE NO : 303-697-8198
PO BOX 218 SE DECISION MADE: 20-MAY-99
INDIAN HILLS, CO 80454 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURESTEP BLOOD GLUCOSE MONITORING SYSTEM
LIFESCAN, INC. 510(k) NO: K984261(TRADITIONAL)
ATTN: ROGER THIES PHONE NO : 202-736-5600
700 THIRTEENTH STREET NW SE DECISION MADE: 21-MAY-99
WASHINGTON, DC 20005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROGAS 7650 TRANSCUTANEOUS MONITOR
LINDE MEDICAL SENSORS AG 510(k) NO: K991644(SPECIAL)
ATTN: ALEX STENZLER PHONE NO : 800-520-4368
AUSTRASSE 25 SE DECISION MADE: 21-MAY-99
BASEL, SWITZERLAND 4051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SKINSENSE NITRILE POWDER-FREE SYNTHETIC MEDICAL EXAMINATION GLOV
LONDON INTERNATIONAL GROUP INC. 510(k) NO: K984249(TRADITIONAL)
ATTN: NEIL ANDERSON PHONE NO : 334-702-2231
P.O. BOX 8308 SE DECISION MADE: 04-MAY-99
2926 COLUMBIA HIGHWAY 510(k) STATEMENT
DOTHAN, AL 36304
DEVICE: BROTHERS VINYL, POWDERED, PATIENT EXAMINATION GLOVES
LONG FIRST (XIAMEN) CO.,LTD. 510(k) NO: K990946(TRADITIONAL)
ATTN: STONE CHEN PHONE NO : 886 075 612201
#23, KOOSHAN 3RD ROAD, SE DECISION MADE: 04-MAY-99
KAOHSIUNG, CHINA (TAIWAN) 510(k) STATEMENT
DEVICE: BROTHERS, VINYL, POWDER-FREE, PATIENT EXAMINATION GLOVES
LONG FIRST (XIAMEN) CO.,LTD. 510(k) NO: K991085(TRADITIONAL)
ATTN: STONE CHEN PHONE NO : 886 075 612201
#23, KOOSHAN 3RD ROAD, SE DECISION MADE: 05-MAY-99
KAOHSIUNG, CHINA (TAIWAN) 510(k) STATEMENT
DEVICE: HEALTH AID PREMIUM PRE-POWDERED NITRILE EXAMINATION GLOVES
M.R.G. INDUSTRIES BERHAD 510(k) NO: K991640(TRADITIONAL)
ATTN: LIM CHONG PHONE NO : 605 891 1111
PT. 4004, JALAN PERUSAHAAN 3 SE DECISION MADE: 28-MAY-99
KAMUNTING INDUSTRIAL ESTATE 510(k) SUMMARY AVAILABLE FROM FDA
KAMUNTING, TAIPING, PERAK, MALAYSIA 34600
DEVICE: BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
MASJU SDN. BHD. 510(k) NO: K991493(TRADITIONAL)
ATTN: HENG CHENG HUI PHONE NO : 044 388 518
PLOT 3, JALAN 1, TIKAM BATU SE DECISION MADE: 26-MAY-99
SUNGAI PETANI, MALAYSIA 08600 510(k) STATEMENT
DEVICE: SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES
MAXXIM MEDICAL, INC. 510(k) NO: K983982(ABBREVIATED)
ATTN: PETER GRAHAM PHONE NO : 727-561-2100
4750 118TH AVE. NORTH SE DECISION MADE: 04-MAY-99
CLEARWATER, FL 34622 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARGON MULTI-LUMEN CENTRAL VENOUS CATHETER
MAXXIM MEDICAL, INC. 510(k) NO: K984189(TRADITIONAL)
ATTN: EDDIE MONROE PHONE NO : 903-675-9321
1445 FLAT CREEK RD. SE DECISION MADE: 05-MAY-99
ATHENS, TX 75751 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRU-CORE I REUSABLE BIOPSY INSTRUMENT
MEDICAL DEVICE TECHNOLOGIES, INC. 510(k) NO: K990839(TRADITIONAL)
ATTN: KARL SWARTZ PHONE NO : 352-338-0440
4600 S.W. 47TH AVE. SE DECISION MADE: 20-MAY-99
GAINESVILLE, FL 32608 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION OF MLT R694 RUBY LASER SYSTEM
MEDICAL LASER TECHNOLOGIES LTD. 510(k) NO: K990902(TRADITIONAL)
ATTN: DAVID HAMILTON PHONE NO : 011 441 383411555
UNIT 15,BELLEKNOWES INDUSTRIAL SE DECISION MADE: 27-MAY-99
ESTATE 510(k) SUMMARY AVAILABLE FROM FDA
INVERKEITHING,FIFE, UNITED KINGDOM KY11 1HY
DEVICE: INTROMIT HAND ACCESS PORT FOR HAND ASSISTED LAPAROSCOPIC SURGERY
MEDTECH LTD. 510(k) NO: K990663(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 13TH STREET N.W. SE DECISION MADE: 27-MAY-99
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ULTRA-SELECT GUIDEWIRE
MICROVENA CORP. 510(k) NO: K991194(SPECIAL)
ATTN: ANGELA MALLERY PHONE NO : 651-777-6700
1861 BUERKLE RD. SE DECISION MADE: 05-MAY-99
WHITE BEAR LAKE, MN 55110-5246 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3M CLINPRO PROPHY PASTE, MODEL 12611
MINNESOTA MINING AND MFG. CO. 510(k) NO: K990482(TRADITIONAL)
ATTN: REBECCA L HANNACK PHONE NO : 651-737-1105
3M CENTER, BUILDING 260-2B-12 SE DECISION MADE: 13-MAY-99
ST. PAUL, MN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DBC, DONG BANG ACUPUNCTURE NEEDLES
MORNING STAR, DONG BANG ACUPUNCTUR510(k) NO: K990328(TRADITIONAL)
ATTN: AE-HOE KWON PHONE NO : 626-403-5959
1429 LYNDON ST. SE DECISION MADE: 04-MAY-99
SOUTH PASADENA, CA 91030-3811 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYGENICLEAR WKR 1, WATER-DELIVERY DEVICE ULTRACLEAR
NEAL DUNNING ASSOC., INC. 510(k) NO: K990479(TRADITIONAL)
ATTN: NEAL DUNNING PHONE NO : 301-122-9213
8309 BRYANT DR. SE DECISION MADE: 13-MAY-99
BETHESDA, MD 20817 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM
OLYMPUS AMERICA, INC. 510(k) NO: K991136(TRADITIONAL)
ATTN: LAURA STORMS TYLER PHONE NO : 516-844-5688
TWO CORPORATE CENTER DR. SE DECISION MADE: 11-MAY-99
MELVILLE, NY 11747-3157 510(k) STATEMENT
DEVICE: OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED WHITE
OMNIGRACE (THAILAND) LTD. 510(k) NO: K990695(TRADITIONAL)
ATTN: K.C. CHOONG PHONE NO : 667 443 9526
641 MOO 5 KANCHANAWANIT RD. SE DECISION MADE: 04-MAY-99
TAMBON BANPRU 510(k) STATEMENT
HATYAI, SONGKHLA, THAILAND 90250
DEVICE: OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE,WHITE
OMNIGRACE (THAILAND) LTD. 510(k) NO: K990696(TRADITIONAL)
ATTN: K.C. CHOONG PHONE NO : 667 443 9526
641 MOO 5 KANCHANAWANIT RD. SE DECISION MADE: 13-MAY-99
TAMBON BANPRU 510(k) STATEMENT
HATYAI, SONGKHLA, THAILAND 90250
DEVICE: OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED PURPLE
OMNIGRACE (THAILAND) LTD. 510(k) NO: K990698(TRADITIONAL)
ATTN: K.C. CHOONG PHONE NO : 667 443 9526
641 MOO 5 KANCHANAWANIT RD. SE DECISION MADE: 13-MAY-99
TAMBON BANPRU 510(k) STATEMENT
HATYAI, SONGKHLA, THAILAND 90250
DEVICE: OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, PURPLE
OMNIGRACE (THAILAND) LTD. 510(k) NO: K990701(TRADITIONAL)
ATTN: K.C. CHOONG PHONE NO : 667 443 9526
641 MOO 5 KANCHANAWANIT RD. SE DECISION MADE: 05-MAY-99
TAMBON BANPRU 510(k) STATEMENT
HATYAI, SONGKHLA, THAILAND 90250
DEVICE: OMNI GRACE LATEX EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED
OMNIGRACE (THAILAND) LTD. 510(k) NO: K990702(TRADITIONAL)
ATTN: K.C. CHOONG PHONE NO : 667 443 9526
641 MOO 5 KANCHANAWANIT RD. SE DECISION MADE: 04-MAY-99
TAMBON BANPRU 510(k) STATEMENT
HATYAI, SONGKHLA, THAILAND 90250
DEVICE: ORALGIENE TONGUE CLEANER
ORALGIENE USA, INC. 510(k) NO: K990344(TRADITIONAL)
ATTN: BILL MUCKLEROY PHONE NO : 310-204-7888
8460 HIGUERA ST. SE DECISION MADE: 04-MAY-99
CULVER CITY, CA 90232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORATEC INTERVENTIONS ORA-50 S PROGRAMMABLE ELECTROTHERMAL SPINE
ORATEC INTERVENTIONS, INC. 510(k) NO: K990474(TRADITIONAL)
ATTN: SHEILA RAMERMAN PHONE NO : 650-687-3475
3700 HAVEN CT. SE DECISION MADE: 17-MAY-99
MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEMP TELLER-INFRARED TYMPANIC THERMOMETER, MODELS TT-200, TT-201
ORIENTAL SYSTEM TECHNOLOGY INC. 510(k) NO: K984497(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511
55 NORTHERN BLVD SE DECISION MADE: 26-MAY-99
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II CALIBRATORS, VITROS I
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K983875(TRADITIONAL)
ATTN: ANNE ZAVERTNIK PHONE NO : 716-453-3790
100 INDIGO CREEK DR. SE DECISION MADE: 14-MAY-99
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS ANEMIA CONTROLS
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K990016(TRADITIONAL)
ATTN: ANNE ZAVERTNIK PHONE NO : 716-453-3790
100 INDIGO CREEK DRIVE SE DECISION MADE: 19-MAY-99
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CENTRAFIX EXTERNAL FIXATOR
OWANDAR MEDICAL LTD 510(k) NO: K991732(TRADITIONAL)
ATTN: JOHN RADWELL PHONE NO : 014 944 84250
PO BOX 389 SE DECISION MADE: 21-MAY-99
HIGH WYCOMBE 510(k) SUMMARY AVAILABLE FROM FDA
HP14 3XP, UNITED KINGDOM
DEVICE: SYNERGY IOM SYSTEM
OXFORD INSTRUMENTS MEDICAL SYSTEMS510(k) NO: K984052(TRADITIONAL)
ATTN: E J SMITH PHONE NO : 410-451-0639
P.O. BOX 4341 SE DECISION MADE: 17-MAY-99
CROFTON, MD 21114 510(k) STATEMENT
DEVICE: LATEX EXAMINATION GLOVES- POWDER FREE, SIZES EXTRA SMALL, SMALL,
P. T. TATA RUBBERINDO INDUSTRIES 510(k) NO: K991158(TRADITIONAL)
ATTN: EMMY TJOENG PHONE NO : 626-913-1798
889 SOUTH AZUSA AVENUE SE DECISION MADE: 28-MAY-99
INDUSTRY, CA 91748 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOTALBOND
PARKELL PRODUCTS, INC. 510(k) NO: K990381(TRADITIONAL)
ATTN: NELSON J GENDUSA PHONE NO : 516-249-1134
155 SCHMITT BLVD. SE DECISION MADE: 17-MAY-99
FARMINGDALE, NY 11735 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTEMP
PARKELL PRODUCTS, INC. 510(k) NO: K991270(TRADITIONAL)
ATTN: NELSON J GENDUSA PHONE NO : 516-249-1134
155 SCHMITT BLVD. SE DECISION MADE: 21-MAY-99
FARMINGDALE, NY 11735 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALLERGEN IMMUNOCAP, MODELS E7, F93, F94, F95, F203, F204, F208,
PHARMACIA & UPJOHN CO. 510(k) NO: K991048(TRADITIONAL)
ATTN: KAREN E MATIS PHONE NO : 614-794-3324
5094 ST. ANDREWS DRIVE SE DECISION MADE: 14-MAY-99
WESTERVILLLE, OH 43082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHILIPS TOMOSCAN AV-NT
PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K991278(TRADITIONAL)
ATTN: FRANK GIANELLI PHONE NO : 203-926-7729
710 BRIDGEPORT AVENUE SE DECISION MADE: 13-MAY-99
P.O. BOX 860 510(k) SUMMARY AVAILABLE FROM FDA
SHELTON, CT 06484-0197
DEVICE: PHILIPS EASY VISION FAMILY WORKSTATION LEGS OPTION
PHILIPS MEDICAL SYSTEMS, INC. 510(k) NO: K990455(TRADITIONAL)
ATTN: FRANK GIANELLI PHONE NO : 203-926-7729
710 BRIDGEPORT AVENUE SE DECISION MADE: 12-MAY-99
SHELTON, CT 06484-4708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAMOND II VALVE
PHOENIX BIOMEDICAL CORP. 510(k) NO: K991429(SPECIAL)
ATTN: COURTNEY SMITH PHONE NO : 610-539-9300
2495 GENERAL ARMSTEAD AVE. SE DECISION MADE: 19-MAY-99
NORRISTOWN, PA 19403 510(k) STATEMENT
DEVICE: LIFEPAK 500 BIPHASIC
PHYSIO-CONTROL CORP. 510(k) NO: K983393(TRADITIONAL)
ATTN: SHERRI L POCOCK PHONE NO : 425-867-4332
11811 WILLOWS RD., N.E. SE DECISION MADE: 05-MAY-99
REDMOND, WA 98073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTICAL FORCEPS
PILLING WECK SURGICAL 510(k) NO: K990561(TRADITIONAL)
ATTN: ELIZABETH LAZARO PHONE NO : 800-523-6507
420 DELAWARE DR. SE DECISION MADE: 14-MAY-99
FORT WASHINGTON, PA 19034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JACKSON ESOPHAGEAL DILATOR
PILLING WECK SURGICAL 510(k) NO: K990935(TRADITIONAL)
ATTN: ELIZABETH LAZARO PHONE NO : 800-523-6507
420 DELAWARE DR. SE DECISION MADE: 17-MAY-99
FORT WASHINGTON, PA 19034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BERACLAMP, MODEL BC-1
POAMAX L.L.C. 510(k) NO: K990045(TRADITIONAL)
ATTN: MICHAEL J PALMER PHONE NO : 757-868-9865
17 ALPHUS ST. SE DECISION MADE: 24-MAY-99
POGUOSON, VA 23662 510(k) STATEMENT
DEVICE: MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470
POLYMER TECHNOLOGY SYSTEMS, INC. 510(k) NO: K990247(TRADITIONAL)
ATTN: MARGO ENRIGHT PHONE NO : 317-870-5610
7736 ZIONSVILLE ROAD SE DECISION MADE: 28-MAY-99
INDIANAPOLIS, IN 46268 510(k) STATEMENT
DEVICE: APOLLO 5, APOLLO 10
PRECITRON A.B. 510(k) NO: K990383(TRADITIONAL)
ATTN: KJELL WESTERLUND PHONE NO : 461 830 0690
ULTUNAALLEN 2 SE DECISION MADE: 05-MAY-99
UPPSALA, SWEDEN S-756 51 510(k) STATEMENT
DEVICE: MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TE
PRINCETON BIOMEDITECH CORP. 510(k) NO: K991299(TRADITIONAL)
ATTN: JEMO KANG PHONE NO : 732-274-1000
4242 U.S. RT. 1 SE DECISION MADE: 28-MAY-99
MONMOUTH JUNCTION, NJ 08852-1905 510(k) STATEMENT
DEVICE: ROCS ULTRASEED
RADIATION ONCOLOGY COMPUTER SYSTEM510(k) NO: K984241(TRADITIONAL)
ATTN: CHARLENE NEBLETT PHONE NO : 760-929-1811
6190 CORTE DEL CEDRO SE DECISION MADE: 12-MAY-99
CARLSBAD, CA 92009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLOUD 1 HUMIDIFICATION SYSTEM
RESPIRATORY SUPPORT PRODUCTS, INC.510(k) NO: K983862(TRADITIONAL)
ATTN: GORDON SHIGEZAWA PHONE NO : 949-756-2250
2552 MCGRAW AVENUE SE DECISION MADE: 24-MAY-99
IRVINE, CA 92704 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIPAP HARMONY S/T, MODEL 1001445
RESPIRONICS, INC. 510(k) NO: K984407(ABBREVIATED)
ATTN: DAVID J VANELLA PHONE NO : 724-733-5866
1001 MURRY RIDGE DR. SE DECISION MADE: 19-MAY-99
MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STICK-ON DISPOSABLE NASAL MASK, MODEL 312174, 1001964
RESPIRONICS, INC. 510(k) NO: K990574(TRADITIONAL)
ATTN: DAVID J VANELLA PHONE NO : 724-733-5866
1001 MURRY RIDGE DR. SE DECISION MADE: 24-MAY-99
MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 3600
RESPIRONICS, INC. 510(k) NO: K991627(SPECIAL)
ATTN: BETSY CORTELLONI PHONE NO : 770-429-2894
1255 KENNESTONE CIR. SE DECISION MADE: 17-MAY-99
MARIETTA, GA 30066 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REUSABLE CONTOUR II NASAL MASK
RESPIRONICS, INC. 510(k) NO: K991648(SPECIAL)
ATTN: DAVID J VANELLA PHONE NO : 724-733-5866
1001 MURRY RIDGE DRIVE SE DECISION MADE: 28-MAY-99
MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-STERI
RIVERSTONE RESOURCES SDN. BHD. 510(k) NO: K990963(TRADITIONAL)
ATTN: CHU MEE CHONG PHONE NO : 603 636 8077
5, LORONG HELANG HINDIK SE DECISION MADE: 26-MAY-99
KEPONG BARU INDUSTRIAL ESTATE 510(k) STATEMENT
KUALA LUMPAR, MALAYSIA 52100
DEVICE: NORMAL SALINE FLUSH SYRINGE
ROCAP DIV. OF SABRATEK CORP. 510(k) NO: K984614(TRADITIONAL)
ATTN: AVIA TONEY PHONE NO : 407-855-5104
1629 PRIME COURT SE DECISION MADE: 27-MAY-99
BUILDING 100 510(k) STATEMENT
ORLANDO, FL 32809
DEVICE: MODIFICATION TO ABUSCREEN ONLINE BARBITURATES
ROCHE DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K983698(TRADITIONAL)
ATTN: RITA SMITH PHONE NO : 908-253-7545
BRANCHBURG TOWNSHIP SE DECISION MADE: 03-MAY-99
1080 U.S. HIGHWAY 202 510(k) SUMMARY AVAILABLE FROM FDA
BRANCHBURG, NJ 08876-3771
DEVICE: ROCHE COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
ROCHE MOLECULAR SYSTEMS, INC. 510(k) NO: K974342(TRADITIONAL)
ATTN: ALEX WESOLOWSKI PHONE NO : 908-253-7540
1080 U.S. HIGHWAY 202 SE DECISION MADE: 28-MAY-99
SOMERVILLE, NJ 08876-3771 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VAPO-SOLUTION FOR USE IN MDT HARVEY CHEMICLAVE STERILIZERS, MODE
ROGER L. GOODMAN, D.D.S., P.C. 510(k) NO: K984270(TRADITIONAL)
ATTN: ROGER L GOODMAN PHONE NO : 517-676-5200
200 TEMPLE ST. SE DECISION MADE: 20-MAY-99
MASON, MI 48854-1837 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION OF SAS SERUM/URINE HCG
SA SCIENTIFIC, INC. 510(k) NO: K990684(TRADITIONAL)
ATTN: JOSH WESSLING PHONE NO : 210-699-8800
4919 GOLDEN QUAIL SE DECISION MADE: 10-MAY-99
SAN ANTONIO, TX 78240 510(k) STATEMENT
DEVICE: SAS ONE-STEP PREGNANCY
SA SCIENTIFIC, INC. 510(k) NO: K990741(TRADITIONAL)
ATTN: HARBI A SHADFAN PHONE NO : 210-699-8800
4919 GOLDEN QUAIL SE DECISION MADE: 10-MAY-99
SAN ANTONIO, TX 78240 510(k) STATEMENT
DEVICE: SAS HCG-CHECK
SA SCIENTIFIC, INC. 510(k) NO: K991193(TRADITIONAL)
ATTN: J. WESSLING PHONE NO : 210-699-8800
4919 GOLDEN QUAIL SE DECISION MADE: 04-MAY-99
SAN ANTONIO, TX 78240 510(k) STATEMENT
DEVICE: EASYSAFE RETRACTING NEEDLE SYRINGE
SAF-T-MED, INC. 510(k) NO: K991039(TRADITIONAL)
ATTN: JAMES ERBS PHONE NO : 847-842-8444
1250 SOUTH GROVE, SUITE 200 SE DECISION MADE: 21-MAY-99
BARRINGTON, IL 60010-5011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER-FREE LATEX SURGEON'S GLOVE SAFESKIN PFS PLUS CONTAINS 50M
SAFESKIN CORP. 510(k) NO: K991317(TRADITIONAL)
ATTN: EUGENE V GOORCHENKO PHONE NO : 619-509-7010
12671 HIGH BLUFF DR. SE DECISION MADE: 21-MAY-99
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PNEUMATIC DEMAND OXYGEN CONSERVER (PDOC)
SALTER LABORATORIES 510(k) NO: K990678(TRADITIONAL)
ATTN: DUANE KAZAL PHONE NO : 805-854-3166
100 WEST SYCAMORE RD. SE DECISION MADE: 07-MAY-99
ARVIN, CA 93203 510(k) STATEMENT
DEVICE: LATEX EXAMINATION GLOVES (POWDERED)
SAMA KEJURUTERAAN SDN.BHD. 510(k) NO: K984229(TRADITIONAL)
ATTN: KUAN TECK PHONE NO : 603 961 5981
TAMAN BUKIT BELIMBING SE DECISION MADE: 17-MAY-99
43300 BALAKONG 510(k) STATEMENT
SELANGOR D.E., MALAYSIA 43300
DEVICE: CVS PERSONAL LUBRICANT
SAN-MAR LABORATORIES, INC. 510(k) NO: K983216(ABBREVIATED)
ATTN: IRWIN SILVERBERG PHONE NO : 914-592-3130
4 WAREHOUSE LANE SE DECISION MADE: 17-MAY-99
ELMSFORD, NY 10523 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSIGHT SPHINCTER OF ODDI MANOMETRY MODULE, MODEL S981300
SANDHILL SCIENTIFIC, INC. 510(k) NO: K990441(TRADITIONAL)
ATTN: LINDA L DIEDERICH PHONE NO : 303-470-7020
8955 SOUTH RIDGELINE BLVD., SE DECISION MADE: 12-MAY-99
UNIT #500 510(k) SUMMARY AVAILABLE FROM FDA
HIGHLANDS RANCH, CO 80126
DEVICE: DPD-12PCC
SCANDITRONIX MEDICAL AB 510(k) NO: K990734(SPECIAL)
ATTN: EVA LARSTEN PHONE NO : 461 818 0700
STALGATAN 14 SE DECISION MADE: 28-MAY-99
UPPSALA, SWEDEN S-754 50 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMCEE INFUSION INTRODUCER SHEATH, EMCEE INFUSION INTRODUCER SET
SCHNEIDER/NAMIC 510(k) NO: K983039(TRADITIONAL)
ATTN: KARIN L SMITH PHONE NO : 518-798-0067
PRUYN'S ISLAND SE DECISION MADE: 07-MAY-99
GLENS FALLS, NY 12801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISOLOCK SPINAL SYSTEM
SCIENT'X 510(k) NO: K990721(TRADITIONAL)
ATTN: DEBBIE DE LOS SANTOS PHONE NO : 512-834-6237
9800 METRIC BLVD. SE DECISION MADE: 27-MAY-99
AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WRIST BLOOD PRESSURE METER MODEL SE-330
SEIN ELECTRONICS CO., LTD. 510(k) NO: K973078(TRADITIONAL)
ATTN: BRENDA M KELLY PHONE NO : 201-529-3111
ONE LETHBRIDGE PLAZA , SE DECISION MADE: 20-MAY-99
SUITE #1 510(k) SUMMARY AVAILABLE FROM FDA
MAHWAH, NJ 07430
DEVICE: EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR
SELFCARE, INC. 510(k) NO: K991386(TRADITIONAL)
ATTN: CAROL ADILETTO PHONE NO : 781-647-3900
200 PROSPECT ST. SE DECISION MADE: 25-MAY-99
WALTHAM, MA 02154-3457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICT
SELFCARE, INC. 510(k) NO: K991466(TRADITIONAL)
ATTN: CAROL ADILETTO PHONE NO : 781-647-3900
200 PROSPECT ST. SE DECISION MADE: 25-MAY-99
WALTHAM, MA 02154-3457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CTS-310(B)
SHANTOU INSTITUTE OF ULTRASONIC IN510(k) NO: K984161(TRADITIONAL)
ATTN: ROBERT MORTON PHONE NO : 925-210-0715
1106 CHILTERN DRIVE SE DECISION MADE: 05-MAY-99
WALNUT CREEK, CA 94596 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CALCIUM SCORING
SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K990426(TRADITIONAL)
ATTN: ALICIA BUSTOS-JUERGENSEN PHONE NO : 732-321-3243
186 WOOD AVE. SOUTH SE DECISION MADE: 12-MAY-99
ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIEMENS MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER
SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K991661(SPECIAL)
ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500
16 ELECTRONICS AVE. SE DECISION MADE: 28-MAY-99
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GBACT + KIT
SIENCO, INC. 510(k) NO: K984141(SPECIAL)
ATTN: BARBARA DEBIASE PHONE NO : 303-420-1148
4892 VAN GORDON ST., UNIT 203 SE DECISION MADE: 28-MAY-99
WHEATRIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: "DIGI-SNAP"
SNAP LABORATORIES, L.L.C. 510(k) NO: K984169(TRADITIONAL)
ATTN: GIL RAVIV PHONE NO : 847-657-8100
3633 WEST LAKE AVE., SUITE 406 SE DECISION MADE: 26-MAY-99
GLENVIEW, IL 60025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM
SOFAMOR DANEK 510(k) NO: K991460(SPECIAL)
ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 19-MAY-99
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO TENOR SPINAL SYSTEM-PLATES
SOFAMOR DANEK USA,INC. 510(k) NO: K991364(SPECIAL)
ATTN: BAILEY LIPSCOMB PHONE NO : 901-396-3133
1730 PENNSYLVANIA AVE SE DECISION MADE: 19-MAY-99
WASHINGTON, DC 20006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONOTOME
SONOKINETICS, INC. 510(k) NO: K990572(TRADITIONAL)
ATTN: DEBBIE IAMPIETRO PHONE NO : 508-435-9893
7 TIFFANY TRAIL SE DECISION MADE: 21-MAY-99
HOPKINTON, MA 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCANFLEX SOLID COUPLANT MEMBRANE
SONOTECH, INC. 510(k) NO: K983691(TRADITIONAL)
ATTN: MARGARET J LARSON PHONE NO : 360-671-9121
P.O. BOX 2189 SE DECISION MADE: 05-MAY-99
BELLINGHAM, WA 98227 510(k) STATEMENT
DEVICE: 30 PUMP, CONTINUOUS LOW FLOW, 200 PUMP, INTERMITTENT WITH KVO OR
SORENSON MEDICAL INC. 510(k) NO: K991363(SPECIAL)
ATTN: R. DOUGLAS JACOB PHONE NO : 801-352-1888
1375 WEST 8040 SOUTH SE DECISION MADE: 13-MAY-99
WEST JORDAN, UT 84088-8320 510(k) STATEMENT
DEVICE: CONSEAL F
SOUTHERN DENTAL INDUSTRIES, INC. 510(k) NO: K990650(TRADITIONAL)
ATTN: SAMANTHA J CHEETHAM PHONE NO : 415-975-8060
246 FIRST ST., SUITE 204 SE DECISION MADE: 14-MAY-99
SAN FRANCISCO, CA 94105 510(k) STATEMENT
DEVICE: SURGEON'S GLOVES
SRI ANUSHAM RUBBER INDUSTRIES PVT.510(k) NO: K984395(TRADITIONAL)
ATTN: N. PARAMASIVAN PHONE NO : 914 652 33091
PIONEER MANIKANDAN BLDG. SE DECISION MADE: 21-MAY-99
VADASERY, NAGERCOIL, TN, INDIA 629510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERISHARP 2.5-GALLON RSDC, MODEL #RSDC2.5G
STERILOGIC WASTE SYSTEMS, INC. 510(k) NO: K991612(TRADITIONAL)
ATTN: CALVIN A ODHNER PHONE NO : 610-756-3003
9948 KISTLER VALLEY ROAD SE DECISION MADE: 28-MAY-99
SUITE 102, P.O. BOX 84 510(k) SUMMARY AVAILABLE FROM FDA
KEMPTON, PA 19529
DEVICE: STERNGOLD IMPLAMED NARROW PLATFORM DENTAL IMPLANTS AND RELATED P
STERNGOLD 510(k) NO: K991436(SPECIAL)
ATTN: GORDON NELSON PHONE NO : 508-226-5660
23 FRANK MOSSBERG DR. SE DECISION MADE: 07-MAY-99
ATTLEBORO, MA 02703-0967 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE VAULT
STIK STOPPERS INC. 510(k) NO: K990936(TRADITIONAL)
ATTN: DARRYL CRAWFORD PHONE NO : 800-300-1989
6 HAYDEN BRIDGE WAY SE DECISION MADE: 18-MAY-99
SPRINGFIELD, OR 97477 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ITI DENTAL IMPLANT SYSTEM
STRAUMANN USA 510(k) NO: K984104(TRADITIONAL)
ATTN: LINDA JALBERT PHONE NO : 800-448-8168
RESERVOIR PLACE, SE DECISION MADE: 13-MAY-99
1601 TRAPELO ROAD 510(k) SUMMARY AVAILABLE FROM FDA
WALTHAM, MA 02451
DEVICE: STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM
STRYKER INSTRUMENTS 510(k) NO: K991703(SPECIAL)
ATTN: NICOLE PETTY PHONE NO : 616-323-7700
4100 EAST MILHAM AVE. SE DECISION MADE: 27-MAY-99
KALAMAZOO, MI 49001 510(k) STATEMENT
DEVICE: SUPERGLOVES, POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES
SUPERMAX SDN BHD 510(k) NO: K991415(TRADITIONAL)
ATTN: STANLEY THAI PHONE NO : 603 657 2328
LOT 42, PUTRA INDUSTRIAL PARK SE DECISION MADE: 26-MAY-99
BUKIT RAHMAN PUTRA 510(k) STATEMENT
SUNGAI PELONG, SELANGOR, MALAYSIA 47500
DEVICE: SURGISORB
SUTURES LTD. 510(k) NO: K990432(TRADITIONAL)
ATTN: ELEANOR JONES PHONE NO : 019 788 23664
VAUXHALL IND. ESTATE SE DECISION MADE: 27-MAY-99
RUABON RD. 510(k) STATEMENT
CLWYD, UNITED KINGDOM LL14 6HA
DEVICE: QUANTEC-E ENDO SYSTEM
SYBRON DENTAL SPECIALTIES INC. 510(k) NO: K990739(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE SE DECISION MADE: 26-MAY-99
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCRAMBLED ENDOOTO LASER PROBE, STRAIGHT TIP, MODEL 59.02, SCRAMB
SYNERGETICS, INC. 510(k) NO: K990568(TRADITIONAL)
ATTN: KURT W GAMPP PHONE NO : 314-939-5100
88 HUBBLE DR. SE DECISION MADE: 14-MAY-99
ST. CHARLES, MO 63304-8694 510(k) STATEMENT
DEVICE: TA CHIA POWDERED NON-STERILE NITRILE PATIENT EXAMINATION GLOVES
TA CHIA RUBBER IND. CORP. 510(k) NO: K990575(TRADITIONAL)
ATTN: CHIN-MING YANG PHONE NO : 886 468 63359
903 CHUNG SHAN RD., SEC. 2 SE DECISION MADE: 04-MAY-99
TA CHIA, TAICHUNG, CHINA (TAIWAN) 510(k) STATEMENT
DEVICE: TA CHIA POWDER FREE NON-STERILE NITRILE PATIENT EXAMINATION GLOV
TA CHIA RUBBER IND. CORP. 510(k) NO: K990577(TRADITIONAL)
ATTN: CHIN-MING YANG PHONE NO : 886 468 63359
903 CHUNG SHAN RD., SEC. 2 SE DECISION MADE: 04-MAY-99
TA CHIA, TAICHUNG, CHINA (TAIWAN) 510(k) STATEMENT
DEVICE: ELECTRODE NEEDLES
TECHNOMED EUROPE 510(k) NO: K990015(TRADITIONAL)
ATTN: HARRY KNUTH PHONE NO : 31 464 370371
STATIONSTRAAT 122 SE DECISION MADE: 27-MAY-99
P.O. BOX 239 510(k) SUMMARY AVAILABLE FROM FDA
6191 BG BEEK, NETHERLANDS 6191 BG
DEVICE: SENSIFLEX POWDERFREE LATEX EXAMINATION GLOVE
TERANG NUSA SDN BHD 510(k) NO: K990488(TRADITIONAL)
ATTN: CHIN GUAN LOW PHONE NO : 609 773 5133
LOT E4(4), JALAN 8 SE DECISION MADE: 28-MAY-99
PENGKALAN CHEPA II FTZ 510(k) SUMMARY AVAILABLE FROM FDA
KOTA BHARU, KELANTAN, MALAYSIA 16100
DEVICE: NUGARD NITRIL POWDERFREE NITRILE EXAMINATION GLOVE
TERANG NUSA SDN BHD 510(k) NO: K990840(TRADITIONAL)
ATTN: CHIN-GUAN LOW PHONE NO : 609 773 5133
1 JALAN 8, PENGKALAN CHEPA 2 SE DECISION MADE: 17-MAY-99
INDUSTRIAL ZONE, 510(k) SUMMARY AVAILABLE FROM FDA
KOTA BHARU, KELANTAN, MALAYSIA 16100
DEVICE: NUGARD NITRIL NITRILE EXAMINATION GLOVE
TERANG NUSA SDN BHD 510(k) NO: K990841(TRADITIONAL)
ATTN: CHIN-GUAN LOW PHONE NO : 609 773 5133
1 JALAN 8, PENGKALAN CHEPA 2 SE DECISION MADE: 17-MAY-99
INDUSTRIAL ZONE, 510(k) SUMMARY AVAILABLE FROM FDA
KOTA BHARU, KELANTAN, MALAYSIA 16100
DEVICE: ETB TROCAR SYSTEM
THE ALTOMEC CORP. 510(k) NO: K990894(TRADITIONAL)
ATTN: JIM CHITTY PHONE NO : 626-960-3449
400 CRENSHAW BLVD., SUITE 109 SE DECISION MADE: 19-MAY-99
TORRANCE, CA 90503 510(k) STATEMENT
DEVICE: NEUROSIGN 400, 4 CHANNEL MOTOR NERVE MONITOR
THE MAGSTIM COMPANY LTD. 510(k) NO: K991583(SPECIAL)
ATTN: REZA JALINOUS PHONE NO : 888-624-7846
730 FIFTH AVE, 9TH FLOOR SE DECISION MADE: 19-MAY-99
NEW YORK, NY 10019 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TTCGHI-T AND TTCTN3-T-T
TINNITUS TREATMENT CENTERS, INC. 510(k) NO: K982451(TRADITIONAL)
ATTN: DAVID W HOLMES PHONE NO : 800-871-4327
8215 WESTCHESTER, SUITE 150 SE DECISION MADE: 07-MAY-99
DALLAS, TX 75225 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLYMER COATED POWDERFREE LATEX EXAMINTATION GLOVES
TOP GLOVE SDN. BHD. 510(k) NO: K990690(TRADITIONAL)
ATTN: LIM WEE CHAI PHONE NO : 603 392 19921905
41050 KLANG,SELANGOR SE DECISION MADE: 20-MAY-99
DARUL EHSAN, MALAYSIA 510(k) STATEMENT
DEVICE: EXCELART
TOSHIBA AMERICA MRI, INC. 510(k) NO: K990620(TRADITIONAL)
ATTN: HSU CHANG PHONE NO : 650-872-2722
280 UTAH AVE. SE DECISION MADE: 14-MAY-99
SOUTH SAN FRANCISCO, CA 94080-6883510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXTRA LARGE BODY COIL FOR OPART (MRT-600)
TOSHIBA AMERICA MRI, INC. 510(k) NO: K991057(TRADITIONAL)
ATTN: KEN NEHMER PHONE NO : 650-872-2722
280 UTAH AVE. SE DECISION MADE: 20-MAY-99
SOUTH SAN FRANCISCO, CA 94080-6883510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIA-PACK FT3 ASSAY
TOSOH MEDICS, INC. 510(k) NO: K991252(TRADITIONAL)
ATTN: LOIS NAKAYAMA PHONE NO : 650-615-4970
347 OYSTER POINT BLVD., SE DECISION MADE: 11-MAY-99
SUITE 201 510(k) STATEMENT
SOUTH SAN FRANCISCO, CA 94080
DEVICE: POWDER FREE LATEX EXAMINATION GLOVES
TOWER RUBBER INDUSTRIES SDN. BHD. 510(k) NO: K990686(TRADITIONAL)
ATTN: S. VICKNESWARAN PHONE NO : 603 376 1568
LOT 18, JALAN LINGKARAN SULTAN SE DECISION MADE: 04-MAY-99
HISHAMUDDIN, KAW. PERUSAHAAN 510(k) STATEMENT
SELAT KLANG UTARA, PORT KLANG, MALAYSIA 42000
DEVICE: UROMED BRACHYTHERAPHY IODINE-125 SOURCES
UROMED CORP. 510(k) NO: K982226(TRADITIONAL)
ATTN: FREDERICK TOBIA PHONE NO : 781-433-0033
64 A ST. SE DECISION MADE: 13-MAY-99
NEEDHAM, MA 02194 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 1000 PRESSURE INFUSION SIGMACON 1000
VALLEY WEST, INC. 510(k) NO: K990447(TRADITIONAL)
ATTN: C. KENNETH FRENCH PHONE NO : 254-435-2306
HWY. 6 NORTH SE DECISION MADE: 12-MAY-99
MERIDIAN, TX 76665 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISTA STEREOSCOPE SYSTEM
VISTA MEDICAL TECHNOLOGIES, INC. 510(k) NO: K990635(TRADITIONAL)
ATTN: VICKI S ANASTASI PHONE NO : 508-366-3668
134 FLANDERS RD. SE DECISION MADE: 19-MAY-99
WESTBOROUGH, MA 01581 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUVUE (ETAFILCON A)SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND
VISTAKON, JOHNSON & JOHNSON VISION510(k) NO: K991134(TRADITIONAL)
ATTN: MARTINE D MARTINO PHONE NO : 904-443-1808
4500 SALISBURY ROAD SE DECISION MADE: 06-MAY-99
SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA
JACKSONVILLE, FL 32216
DEVICE: ADVANCED DIAGNOSTIC VIEWER (AOX), MODEL VITRED 1.3
VITAL IMAGES, INC. 510(k) NO: K990442(TRADITIONAL)
ATTN: ROBERT C SAMEC PHONE NO : 612-915-8001
3100 WEST LAKE ST. SE DECISION MADE: 11-MAY-99
MINNEAPOLIS, MN 55416 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED)
WALLACH SURGICAL DEVICES, INC. 510(k) NO: K983840(TRADITIONAL)
ATTN: MICHAEL MALIS PHONE NO : 203-799-2000
235 EDISON RD. SE DECISION MADE: 20-MAY-99
ORANGE, CT 06477 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LORENZ IMF SCREW
WALTER LORENZ SURGICAL, INC. 510(k) NO: K983728(TRADITIONAL)
ATTN: DIANA PRESTON PHONE NO : 904-741-4400
1520 TRADEPORT DR. SE DECISION MADE: 13-MAY-99
JACKSONVILLE, FL 32218 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTRA-UTERINE TRANSFER, INTRA-FOLOPIAN TRANSFER
WASHINGTON REGULATORY SERVICES 510(k) NO: K983604(TRADITIONAL)
ATTN: RANDOLPH L COOKE PHONE NO : 609-466-0510
23 WELISEWITZ ROAD SE DECISION MADE: 27-MAY-99
RINGOES, NJ 08551 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FRESGLOOK BIFOCAL UV-ABSORBING (PHEMFILCON A) MOLDED SPHERICAL H
WESLEY-JESSEN 510(k) NO: K991550(TRADITIONAL)
ATTN: JOSEPH FOOS PHONE NO : 847-294-3306
333 EAST HOWARD AVE. SE DECISION MADE: 14-MAY-99
DES PLAINES, IL 60018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGG ELISA TEST
ZEUS SCIENTIFIC, INC. 510(k) NO: K983805(TRADITIONAL)
ATTN: MARK J KOPNITSKY PHONE NO : 908-526-3744
P.O. BOX 38 SE DECISION MADE: 26-MAY-99
RARITAN, NJ 08869 510(k) STATEMENT
DEVICE: THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYS
ZEUS SCIENTIFIC, INC. 510(k) NO: K984120(TRADITIONAL)
ATTN: MARK J KOPNITSKY PHONE NO : 908-526-3744
200 EVANS WAY SE DECISION MADE: 26-MAY-99
BRANCHBURG, NJ 08876 510(k) STATEMENT
DEVICE: THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SY
ZEUS SCIENTIFIC, INC. 510(k) NO: K984135(TRADITIONAL)
ATTN: MARK J KOPNITSKY PHONE NO : 908-526-3744
200 EVANS WAY SE DECISION MADE: 26-MAY-99
BRANCHBURG, NJ 08876 510(k) STATEMENT
DEVICE: GAS PLASMA STERILIZATION
ZIMMER, INC. 510(k) NO: K972774(TRADITIONAL)
ATTN: RALPH H LARSEN PHONE NO : 219-372-4129
P.O. BOX 708 SE DECISION MADE: 05-MAY-99
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZYMED TELEMETRY SYSTEM: MODEL EASIVIEW
ZYMED CORP. 510(k) NO: K990093(TRADITIONAL)
ATTN: DUDLEY HARRIS PHONE NO : 800-235-5941
20 NORTH AVIADOR ST. SE DECISION MADE: 11-MAY-99
CAMARILLO, CA 93010 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 248
TOTAL WITH SUMMARIES 162
TOTAL WITH STATEMENTS 86
Updated 8/3/1999
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