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510(k)s Final Decisions Rendered for June 1999 |
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DEVICE: AST/SGOT
A.P. TOTAL CARE, INC. 510(k) NO: K991663(TRADITIONAL)
ATTN: LUIS P LEON PHONE NO : 203-335-9277
70 HAWLEY AVE, SE DECISION MADE: 30-JUN-99
PO BOX 6216 510(k) STATEMENT
BRIDGEPORT, CT
DEVICE: TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02
A.P. TOTAL CARE, INC. 510(k) NO: K991666(TRADITIONAL)
ATTN: LUIS P LEON PHONE NO : 203-335-9277
70 HAWLEY AVE, SE DECISION MADE: 30-JUN-99
PO BOX 6216 510(k) STATEMENT
BRIDGEPORT, CT
DEVICE: HEPA-CARE AIR CLEANER AMERICAN AIR FILTER AIR FILTRATION SYSTEM
ABATEMENT TECHNOLOGIES, INC. 510(k) NO: K984116(TRADITIONAL)
ATTN: DAVID WILLYARD PHONE NO : 770-339-2600
2220 NORTHMONT PKWY., SE DECISION MADE: 24-JUN-99
SUITE 100 510(k) STATEMENT
DULUTH, GA
DEVICE: CELL-DYN 1200 SYSTEM
ABBOTT LABORATORIES, INC. 510(k) NO: K991142(ABBREVIATED)
ATTN: JANICE E BROWN PHONE NO : 408-567-3521
5440 PATRICK HENRY DR. SE DECISION MADE: 23-JUN-99
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRP
ABBOTT LABORATORIES, INC. 510(k) NO: K991372(TRADITIONAL)
ATTN: LINDA MORRIS PHONE NO : 972-518-6711
1920 HURD SE DECISION MADE: 01-JUN-99
IRVING, TX 75062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE ACME MEDICAL AESTHETIC ND:YAG LASER
ACME MEDICAL, INC. 510(k) NO: K991234(TRADITIONAL)
ATTN: MIKE LEVERNIER PHONE NO : 650-372-1332
1181 CHESS DRIVE, SUITE B SE DECISION MADE: 28-JUN-99
FOSTER CITY, CA 94404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPYROGEL HYDROGEL WOUND AND BURN DRESSING SA
ADVANCED MEDICAL SOLUTIONS GROUP P510(k) NO: K991287(TRADITIONAL)
ATTN: CHRISTOPHER OAKES PHONE NO : 011 441 606863500
ROAD THREE, SE DECISION MADE: 29-JUN-99
WINFORD INDUSTRIAL ESTATE 510(k) SUMMARY AVAILABLE FROM FDA
WINSFORD, CHESHIRE, UNITED KINGDOM CW7 3PD
DEVICE: ADVANCED MEDICAL SOLUTIONS-SILICONE GEL SCAR MANAGEMENT SHEET
ADVANCED MEDICAL SOLUTIONS GROUP P510(k) NO: K991630(TRADITIONAL)
ATTN: CHRIS OAKES PHONE NO : 011 441 606863500
ROAD THREE, SE DECISION MADE: 11-JUN-99
WINFORD INDUSTRIAL ESTATE 510(k) SUMMARY AVAILABLE FROM FDA
WINSFORD, CHESHIRE, UNITED KINGDOM CW7 3PD
DEVICE: LAMITRODE LEADS
ADVANCED NEUROMODULATION SYSTEMS, 510(k) NO: K990469(TRADITIONAL)
ATTN: DREW JOHNSON PHONE NO : 972-390-9800
ONE ALLENTOWN PKWY. SE DECISION MADE: 03-JUN-99
ALLEN, TX 75002-4211 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RENEW LEAD EXTENSION
ADVANCED NEUROMODULATION SYSTEMS, 510(k) NO: K991784(SPECIAL)
ATTN: KATRYNA WARREN PHONE NO : 972-390-9800
ONE ALLENTOWN PKWY. SE DECISION MADE: 24-JUN-99
ALLEN, TX 75002-4211 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION OF: STERRAD BI TEST PACK
ADVANCED STERILIZATION PRODUCTS 510(k) NO: K991675(SPECIAL)
ATTN: KEVIN CORRIGAN PHONE NO : 949-453-6410
33 TECHNOLOGY DR. SE DECISION MADE: 15-JUN-99
IRVINE, CA 92718 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM
ADVANCED TECHNOLOGY LABORATORIES, 510(k) NO: K991671(TRADITIONAL)
ATTN: TERRENCE J SWEENEY PHONE NO : 425-487-7602
22100 BOTHELL EVERETT HWY. SE DECISION MADE: 18-JUN-99
P.O. BOX 3003 510(k) SUMMARY AVAILABLE FROM FDA
BOTHELL, WA 98041-3003
DEVICE: AKTINA MEDICALPHYSICS CORPORATION MECHANICAL FRONTPOINTER
AKTINA MEDICAL PHYSICS CORP. 510(k) NO: K990997(TRADITIONAL)
ATTN: JOAN Z ACHAROPOULOS PHONE NO : 914-268-0101
360 NORTH ROUTE 9W SE DECISION MADE: 22-JUN-99
CONGERS, NY 10920 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BROWNE MVI ETHYLENE OXIDE INDICATOR
ALBERT BROWNE LTD. 510(k) NO: K991418(ABBREVIATED)
ATTN: CYNTHIA J.M. NOLTE PHONE NO : 919-859-4207
49 PLAIN STREET SE DECISION MADE: 10-JUN-99
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODULAR LAPAROSCOPIC GRASPING FORCEPS, SCISSORS, NEEDLE HOLDERS
ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K991928(SPECIAL)
ATTN: PATRICIA SHARPE-GREGG PHONE NO : 847-578-3636
1500 WAUKEGAN RD. SE DECISION MADE: 25-JUN-99
WILLIAM MERZ BUILDING 510(k) SUMMARY AVAILABLE FROM FDA
MCGAW PARK, IL 60085
DEVICE: AMIB7
ALLIANCE MEDICAL, INC. 510(k) NO: K990198(TRADITIONAL)
ATTN: JAMES RIEDL PHONE NO : 514 344 3030
7800 COTE DE LIESSE SE DECISION MADE: 29-JUN-99
ST. LAURENT, QUEBEC, CANADA H4T 1G510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALPHAMED GEMINI SENSOR, SNORING SENSOR
ALPHAMED, INC. 510(k) NO: K990321(TRADITIONAL)
ATTN: PETER STASE PHONE NO : 612-789-8200
3989 CENTRAL AVE. NE SE DECISION MADE: 01-JUN-99
SUITE 560 510(k) SUMMARY AVAILABLE FROM FDA
MINNEAPOLIS, MN 55421
DEVICE: MODIFICATION TO 'RAPID DRUG SCREEN' 9-PANEL
AMERICAN BIO MEDICA CORP. 510(k) NO: K992033(TRADITIONAL)
ATTN: JOHN B DUBECK PHONE NO : 202-434-4125
1001 G STREET, NW SE DECISION MADE: 30-JUN-99
SUITE 500W 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20001
DEVICE: AMERICAN DENTAL PRODUCTS ETCH-DETECT
AMERICAN DENTAL PRODUCTS, INC. 510(k) NO: K991099(TRADITIONAL)
ATTN: GEORGE NICOLAE PHONE NO : 630-238-0275
603-B COUNTRY CLUB DR. SE DECISION MADE: 10-JUN-99
BENSENVILLE, IL 60106-1329 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COAGULOOP
AMERICAN MEDICAL SYSTEMS, INC. 510(k) NO: K991314(TRADITIONAL)
ATTN: DAVID WORRELL PHONE NO : 612-933-4666
10700 BREN RD., WEST SE DECISION MADE: 29-JUN-99
MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMIGO MODEL 590000
AMIGO MOBILITY INTL., INC. 510(k) NO: K983987(TRADITIONAL)
ATTN: DALE CONFER PHONE NO : 517-777-0910
6693 DIXIE HIGHWAY SE DECISION MADE: 08-JUN-99
BRIDGEPORT, MI 48722 510(k) STATEMENT
DEVICE: SOFTINJECT
ANDROSYSTEMS SRL 510(k) NO: K991680(TRADITIONAL)
ATTN: MARIA E DONAWA PHONE NO : 390 657 82665
VIALE LIEGI, 12 SE DECISION MADE: 03-JUN-99
ROME, ITALY 00198 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANGIODYNAMICS BALLOON EXPANDABLE BILIARY STENT SYSTEM
ANGIODYNAMICS, INC. 510(k) NO: K991793(SPECIAL)
ATTN: TERI JUCKETT PHONE NO : 518-798-1215
603 QUEENSBURY AVE. SE DECISION MADE: 25-JUN-99
QUEENSBURY, NY 12804 510(k) STATEMENT
DEVICE: C-FLEX URETERAL STENTS
APPLIED MEDICAL RESOURCES 510(k) NO: K991219(TRADITIONAL)
ATTN: ANIL BHALANI PHONE NO : 949-582-6120
26051 MERIT CIRCLE, #104 SE DECISION MADE: 21-JUN-99
LAGUNA HILLS, CA 92653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LATEX EXAMINATION GLOVES, POWDER FREE WITH PROTEIN LABELING CLAI
ARISTA LATINDO INDUSTRIAL, LTD. P.510(k) NO: K991686(TRADITIONAL)
ATTN: LINGA SUMARTA PHONE NO : 622 166 20201/195
128 JALAN KYAI HAJI MUHAMMAD SE DECISION MADE: 11-JUN-99
MANSYUR 510(k) STATEMENT
JAKARTA BARAT, INDONESIA 11210
DEVICE: ASTRA TECH IMPLANTS - DENTAL SYSTEM: NEW FIXTURES (MICROMACRO)
ASTRA TECH, INC. 510(k) NO: K991053(TRADITIONAL)
ATTN: NIKLAS LIDSKOG PHONE NO : 781-861-7707
430 BEDFORD STREET SE DECISION MADE: 25-JUN-99
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
LEXINGTON, MA 02420
DEVICE: UNI-GRAFT K DV VASCULAR GRAFT
ATRIUM MEDICAL CORP. 510(k) NO: K991813(TRADITIONAL)
ATTN: JOE DE PAOLO PHONE NO : 603-880-1433
5 WENTWORTH DR. SE DECISION MADE: 01-JUN-99
HUDSON, NH 03051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVOGEL
AVOCET POLYMER TECHNOLOGIES, INC. 510(k) NO: K981353(TRADITIONAL)
ATTN: MARY CAPELLI-SCHELLPFEFFER PHONE NO : 205-533-4201
2305 SPRING BRANCH RD. SE DECISION MADE: 01-JUN-99
HUNTSVILLE, AL 35801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMPACT BALLOON DILATION CATHETER
B. BRAUN/MCGAW 510(k) NO: K983373(TRADITIONAL)
ATTN: MARK S ALSBERGE PHONE NO : 610-997-4360
824 12TH AVENUE SE DECISION MADE: 22-JUN-99
BETHLEHEM, PA 18018-0027 510(k) STATEMENT
DEVICE: RENAL LINK
BAXTER HEALTHCARE CORP. 510(k) NO: K990953(TRADITIONAL)
ATTN: DAVID E CURTIN PHONE NO : 847-473-6079
1620 WAUKEGAN ROAD SE DECISION MADE: 18-JUN-99
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULA
BAXTER RESEARCH MEDICAL, INC. 510(k) NO: K983791(TRADITIONAL)
ATTN: JOHN W SMITH PHONE NO : 801-565-6213
6864 SOUTH 300 WEST SE DECISION MADE: 11-JUN-99
MIDVALE, UT 84047 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLUCOMETER ELITE TEST STRIPS
BAYER CORP. 510(k) NO: K991242(TRADITIONAL)
ATTN: GEORGE M TANCOS PHONE NO : 219-262-6928
1884 MILES AVE. SE DECISION MADE: 30-JUN-99
ELKHART, IN 46515-2004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
BAYER CORP. 510(k) NO: K991576(TRADITIONAL)
ATTN: GABRIEL J MURACA PHONE NO : 914-524-3494
511 BENEDICT AVE. SE DECISION MADE: 30-JUN-99
TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAPNOCHECK II, MODEL 8400
BCI INTL., INC. 510(k) NO: K991086(TRADITIONAL)
ATTN: DONALD ALEXANDER PHONE NO : 414-542-3100
N7 W22025 JOHNSON ROAD SE DECISION MADE: 09-JUN-99
WAUKESHA, WI 53186 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3402 HANDHELD PULSE OXIMETER
BCI INTL., INC. 510(k) NO: K991410(TRADITIONAL)
ATTN: DONALD ALEXANDER PHONE NO : 414-542-3100
N7 W22025 JOHNSON ROAD SE DECISION MADE: 09-JUN-99
WAUKESHA, WI 53186 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNO
BECKMAN 510(k) NO: K991707(SPECIAL)
ATTN: ANGELA BYLAND PHONE NO : 612-368-1615
1000 LAKE HAZELTINE DR. SE DECISION MADE: 01-JUN-99
CHASKA, MN 55318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VARIANT II B-THALASSEMIA
BIO-RAD LABORATORIES, INC. 510(k) NO: K991127(SPECIAL)
ATTN: JULIET CARRARA PHONE NO : 510-741-6188
4000 ALFRED NOBEL DR. SE DECISION MADE: 10-JUN-99
HERCULES, CA 94547 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATA
BIOCHECK, INC. 510(k) NO: K990993(TRADITIONAL)
ATTN: ROBIN HELLEN PHONE NO : 818-709-5646
9418 LASAINE AVE SE DECISION MADE: 22-JUN-99
NORTHRIDGE, CA 91325 510(k) STATEMENT
DEVICE: TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001
BIOCHECK, INC. 510(k) NO: K991146(TRADITIONAL)
ATTN: ROBIN J HELLEN PHONE NO : 818-709-5646
9418 LASAINE AVE SE DECISION MADE: 22-JUN-99
NORTHRIDGE, CA 91325 510(k) STATEMENT
DEVICE: TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005
BIOCHECK, INC. 510(k) NO: K991311(TRADITIONAL)
ATTN: ROBIN J HELLEN PHONE NO : 818-709-5646
9418 LASAINE AVE SE DECISION MADE: 02-JUN-99
NORTHRIDGE, CA 91325 510(k) STATEMENT
DEVICE: BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007
BIOCHECK, INC. 510(k) NO: K991432(TRADITIONAL)
ATTN: ROBIN J HELLEN PHONE NO : 818-709-5646
9418 LASAINE AVE SE DECISION MADE: 02-JUN-99
NORTHRIDGE, CA 91325 510(k) STATEMENT
DEVICE: EPI-FOAM SILICONE SHEETING
BIODERMIS CORP. 510(k) NO: K991604(TRADITIONAL)
ATTN: JEFF S SCHLEUNING PHONE NO : 800-322-3729
3078 EAST SUNSET RD. SUITE #1 SE DECISION MADE: 09-JUN-99
LAS VEGAS, NV 89120 510(k) STATEMENT
DEVICE: BIOPOTENTIAL SKIN ELECTRODE, MODELS BME 300, BME 200, BME 100, B
BIOMED PRODUCTS 510(k) NO: K991199(TRADITIONAL)
ATTN: TIMOTHY THYGESON PHONE NO : 707-576-1924
5262 VISTA GRANDE DR. SE DECISION MADE: 22-JUN-99
SANTA ROSA, CA 95403 510(k) STATEMENT
DEVICE: RC BUTTRESS
BIOMET, INC. 510(k) NO: K991009(TRADITIONAL)
ATTN: TRACY BICKEL PHONE NO : 219-372-1761
AIRPORT INDUSTRIAL PARK SE DECISION MADE: 23-JUN-99
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: COLOR BUFFED ANSWER CEMENTED FEMORAL
BIOMET, INC. 510(k) NO: K991987(SPECIAL)
ATTN: DALENE HUFZIGER BINKLEY PHONE NO : 219-372-1612
AIRPORT INDUSTRIAL PARK SE DECISION MADE: 28-JUN-99
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: BIONIKE AQ BARBITURATE TEST
BIONIKE, INC. 510(k) NO: K990280(TRADITIONAL)
ATTN: CLEVE W LAIRD PHONE NO : 805-522-6223
1420 LOS ANGELES AVENUE SE DECISION MADE: 28-JUN-99
SUITE 201 510(k) SUMMARY AVAILABLE FROM FDA
SIMI VALLEY, CA 93065
DEVICE: BIOSENSOR HOLTER MONITOR SYSTEM SOFTWARE, MODEL 1005
BIOSENSOR CORP. 510(k) NO: K990956(TRADITIONAL)
ATTN: STEVE SPRINGROSE PHONE NO : 612-890-5135
11481 RUPP DRIVE SE DECISION MADE: 14-JUN-99
BURNSVILLE, MN 55337 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOTEST ANTI-EBV RECOMBINANT
BIOTEST DIAGNOSTICS CORP. 510(k) NO: K983839(TRADITIONAL)
ATTN: PATRICIA E BONNESS PHONE NO : 609-397-8511
66 FORD RD., SUITE 131 SE DECISION MADE: 09-JUN-99
DENVILLE, NJ 07834 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOTEST ANTI-EBV RECOMBINANT, EBNA IGG
BIOTEST DIAGNOSTICS CORP. 510(k) NO: K983841(TRADITIONAL)
ATTN: PATRICIA E BONNESS PHONE NO : 609-397-8511
66 FORD RD., SUITE 131 SE DECISION MADE: 09-JUN-99
DENVILLE, NJ 07834 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOTEST ANTI-EBV RECOMBINANT, EA IGM
BIOTEST DIAGNOSTICS CORP. 510(k) NO: K983842(TRADITIONAL)
ATTN: PATRICIA E BONNESS PHONE NO : 609-397-8511
66 FORD RD., SUITE 131 SE DECISION MADE: 09-JUN-99
DENVILLE, NJ 07834 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RETROX RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777
BIOTRONIK, INC. 510(k) NO: K990483(TRADITIONAL)
ATTN: JON BRUMBAUGH PHONE NO : 888-345-0374
6024 JEAN RD. SE DECISION MADE: 03-JUN-99
LAKE OSWEGO, OR 97035-5369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BMT ANSCORE HEALTH MANAGEMENT SYSTEM, MODEL 1.1
BOSTON MEDICAL TECHNOLOGIES, INC. 510(k) NO: K991831(TRADITIONAL)
ATTN: DONALD BROKS PHONE NO : 781-213-9200
591 NORTH AVE., SUITE 5 SE DECISION MADE: 11-JUN-99
WAKEFIELD, MA 01880 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228
BOSTON SCIENTIFIC CORP. 510(k) NO: K990864(TRADITIONAL)
ATTN: ABBY LIPMAN PHONE NO : 508-650-8249
ONE BOSTON SCIENTIFIC PLACE SE DECISION MADE: 11-JUN-99
NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WALLSTENT ENTERAL ENDOPROSTHESIS WITH UNISTEP DELIVERY SYSTEM
BOSTON SCIENTIFIC CORP. 510(k) NO: K991056()
ATTN: DANIEL J DILLON PHONE NO : 508-650-8751
ONE BOSTON SCIENTIFIC DRIVE SE DECISION MADE: 22-JUN-99
NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BONE SCREWS
BREGMA INTERNATIONAL TRADING COMPA510(k) NO: K990351(TRADITIONAL)
ATTN: ASSEM HEDAYAT PHONE NO : 306 934 8270
214-111 RESEARCH DRIVE SE DECISION MADE: 01-JUN-99
SASKATOON, SASKATCHEWAN, CANADA S7510(k) STATEMENT
DEVICE: STAINLESS STEEL FIXATION PINS
BREGMA INTERNATIONAL TRADING COMPA510(k) NO: K990353(TRADITIONAL)
ATTN: ASSEM HEDAYAT PHONE NO : 306 934 8270
214-111 RESEARCH DRIVE SE DECISION MADE: 01-JUN-99
SASKATOON, SASKATCHEWAN, CANADA S7510(k) STATEMENT
DEVICE: BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDER FREE
BRIGHTSWAY HOLDINGS SDN BHD 510(k) NO: K991750(TRADITIONAL)
ATTN: G. BASKARAN PHONE NO : 603 343 1007
BATU BELAH SE DECISION MADE: 23-JUN-99
KLANG SELANGOR DARUL EHSAN, MALAYS510(k) STATEMENT
DEVICE: BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDERED CON
BRIGHTSWAY HOLDINGS SDN BHD 510(k) NO: K991752(TRADITIONAL)
ATTN: G. BASKARAN PHONE NO : 603 343 1007
BATU BELAH SE DECISION MADE: 23-JUN-99
KLANG SELANGOR DARUL EHSAN, MALAYS510(k) STATEMENT
DEVICE: BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDERED)
BRIGHTWAY HOLDINGS SDN. BHD. 510(k) NO: K990876(TRADITIONAL)
ATTN: G. BASKARAN PHONE NO : 603 343 1007
LOT 1559, JALAN ISTIMEWA SE DECISION MADE: 23-JUN-99
BATU BELAH, KLANG 510(k) STATEMENT
SELANGOR DARUL EHSAN, MALAYSIA 42100
DEVICE: CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES
C.V. ANLIS ABADI INTERNASIONAL 510(k) NO: K991155(TRADITIONAL)
ATTN: ANWAR FIRMAN PHONE NO : 626 155 7758573068
JALAN SEKIP BARU, NO 23 SE DECISION MADE: 21-JUN-99
MEDAN, INDONESIA 510(k) STATEMENT
DEVICE: CADISCOPE ELECTRONIC STETHOSCOPE
CADITEC AG 510(k) NO: K990809(TRADITIONAL)
ATTN: BETTY LOCK PHONE NO : 847-949-3109
ONE MEDICAL PLACE SE DECISION MADE: 09-JUN-99
MUNDELEIN, IL 60060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIOLIGHT
CAPINTEC, INC. 510(k) NO: K982448(TRADITIONAL)
ATTN: MARY ANNE DELL PHONE NO : 412-963-1988
540 ALPHA DR. SE DECISION MADE: 11-JUN-99
PITTSBURGH, PA 15238 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TENDER TOUCH SILICONE GEL PADS
CAPITAL MARKETING TECHNOLOGIES, IN510(k) NO: K991478(TRADITIONAL)
ATTN: JOHN SNYDER PHONE NO : 800-887-3370
3630 SOUTH I 35, SUITE A SE DECISION MADE: 21-JUN-99
WACO, TX 76706 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TELEMEDICINE 2000
CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K991307(SPECIAL)
ATTN: LEONID TRACHTENBERG PHONE NO : 972 894 84600
2 PERERIS ST., SCIENCE PARK SE DECISION MADE: 14-JUN-99
REHOVOT, ISRAEL 76100 510(k) STATEMENT
DEVICE: MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER; CARDIAC PATHWAYS EG
CARDIAC PATHWAYS CORP. 510(k) NO: K990795(TRADITIONAL)
ATTN: ERIN DIGNAN PHONE NO : 408-737-0505
995 BENECIA AVE. SE DECISION MADE: 08-JUN-99
SUNNYVALE, CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CERALAS DIODE LASER SYSTEM, MODEL CERALAS D15
CERAMOPTEC, INC. 510(k) NO: K991891(TRADITIONAL)
ATTN: CAROL J MORELLO PHONE NO : 413-525-0600
515 SHAKER ROAD SE DECISION MADE: 24-JUN-99
EAST LONGMEADOW, MA 01028 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 221-1
CHALGREN ENT., INC. 510(k) NO: K982950(TRADITIONAL)
ATTN: RICHARD KAISER PHONE NO : 408-847-3994
8021 CARMEL ST. SE DECISION MADE: 22-JUN-99
GILROY, CA 95020 510(k) STATEMENT
DEVICE: CHIRON DIAGNOSTICS ACS: 180 FOLATE
CHIRON DIAGNOSTICS CORP. 510(k) NO: K991582(TRADITIONAL)
ATTN: WILLIAM J PIGNATO PHONE NO : 508-359-3825
63 NORTH ST. SE DECISION MADE: 30-JUN-99
MEDFIELD, MA 02052-1688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHIRON DIAGNOSTICS ACS: 180 FT3
CHIRON DIAGNOSTICS CORP. 510(k) NO: K991692(TRADITIONAL)
ATTN: WILLIAM J PIGNATO PHONE NO : 508-359-3825
63 NORTH ST. SE DECISION MADE: 18-JUN-99
MEDFIELD, MA 02052-1688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENERAL PURPOSE NEOFLEX TRANSDUCER COVER, EDOCAVITY NEOFLEX TRAN
CIVCO MEDICAL INSTRUMENTS CO., INC510(k) NO: K991236(TRADITIONAL)
ATTN: J. WILLIAM JONES PHONE NO : 319-656-4447
102 FIRST ST. SOUTH SE DECISION MADE: 02-JUN-99
KALONA, IA 52247 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTSPOT 2000
CMT MEDICAL TECHNOLOGIES, LTD. 510(k) NO: K991578(SPECIAL)
ATTN: YESHAYAHU RAZ PHONE NO : 972 485 66233
MATAM HIGH TECHNOLOGY CENTER SE DECISION MADE: 03-JUN-99
HAIFA, ISRAEL 31905 510(k) STATEMENT
DEVICE: MODIFICATION TO WOUN'DRES
COLOPLAST CORP. 510(k) NO: K991202(TRADITIONAL)
ATTN: HARVEY M ARBIT PHONE NO : 507-386-4308
1940 COMMERCE DR. SE DECISION MADE: 04-JUN-99
P.O. BOX 8300 510(k) SUMMARY AVAILABLE FROM FDA
NORTH MANKATO, MN 56003-8300
DEVICE: COLORSOFT, COLOR ENHANCED TINTED SOFT CONTACT LENS
COLORSOFT LABORATORIES CORP. 510(k) NO: K990815(TRADITIONAL)
ATTN: MARTIN DALSING PHONE NO : 970-243-5490
623 GLACIER DRIVE SE DECISION MADE: 03-JUN-99
GRANT JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: "HERMES CONTROL CENTER", WITH CONTROL OF THE AESOP 3000HR (HERME
COMPUTER MOTION, INC. 510(k) NO: K991444(TRADITIONAL)
ATTN: DAVID THOMAS PHONE NO : 805-968-9600
130-B CREMONA DR. SE DECISION MADE: 25-JUN-99
GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION OF: HERMES OPERATING ROOM CONTROL CENTER
COMPUTER MOTION, INC. 510(k) NO: K991734(SPECIAL)
ATTN: DAVID U THOMAS PHONE NO : 805-968-9600
130 CREMONA DRIVE, SUITE B SE DECISION MADE: 09-JUN-99
GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONMED STEALTH NON-STICK ACCESSORY ELECTRODE, MODEL 138XXX
CONMED CORP. 510(k) NO: K991855(SPECIAL)
ATTN: IRA D DUESLER JR PHONE NO : 315-797-8375
310 BROAD ST. SE DECISION MADE: 15-JUN-99
UTICA, NY 13501-1203 510(k) STATEMENT
DEVICE: COOPERSURGICAL COAGULATOR FOR TATTOO REMOVAL
COOPERSURGICAL, INC. 510(k) NO: K990850(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, N.W. SE DECISION MADE: 01-JUN-99
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COOPERSURGICAL INFRARED COAGULATOR
COOPERSURGICAL, INC. 510(k) NO: K990852(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, N.W. SE DECISION MADE: 11-JUN-99
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 6F HYDROLYSER THROMBECTOMY CATHETER
CORDIS CORP. 510(k) NO: K990771(TRADITIONAL)
ATTN: ARIEL MACTAVISH PHONE NO : 305-824-2404
14201 N.W. 60TH AVE. SE DECISION MADE: 25-JUN-99
MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORDIS MAXI DS PTA BALLOON CATHETER
CORDIS CORP. 510(k) NO: K991811(SPECIAL)
ATTN: ARIEL MACTAVISH PHONE NO : 305-824-2332
14201 N.W. 60TH AVE. SE DECISION MADE: 15-JUN-99
MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DADE BEHRING QUIKLYTE METABOLYTE CARTRIDGE, MODEL DIMENSION(R) X
DADE BEHRING, INC. 510(k) NO: K983344(TRADITIONAL)
ATTN: LORRAINE H PIESTRAK PHONE NO : 302-631-6279
RT. 896, GLASCOW BLDG. 500 SE DECISION MADE: 22-JUN-99
NEWARK, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION OF N PROTEIN STANDARD SL
DADE BEHRING, INC. 510(k) NO: K991181(TRADITIONAL)
ATTN: CAROLYN K GEORGE PHONE NO : 781-826-2073
P.O. BOX 6101 SE DECISION MADE: 01-JUN-99
NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: N/T PROTEIN CONTROL LC
DADE BEHRING, INC. 510(k) NO: K991704(TRADITIONAL)
ATTN: REBECCA S AYASH PHONE NO : 781-826-2073
GLASGOW SITE SE DECISION MADE: 25-JUN-99
P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714
DEVICE: DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
DADE MICROSCAN, INC. 510(k) NO: K983922(TRADITIONAL)
ATTN: CYNTHIA VAN DUKER PHONE NO : 916-374-3105
2040 ENTERPRISE BLVD. SE DECISION MADE: 17-JUN-99
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MO
DAKO CORP. 510(k) NO: K991402(TRADITIONAL)
ATTN: GRETCHEN M MURRAY PHONE NO : 805-566-6655
6392 VIA REAL SE DECISION MADE: 21-JUN-99
CARPINTERIA, CA 93013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOUSE IGG1 NEGATIVE CONTROLS
DAKO CORP. 510(k) NO: K991454(TRADITIONAL)
ATTN: GRETCHEN M MURRAY PHONE NO : 805-566-6655
6392 VIA REAL SE DECISION MADE: 21-JUN-99
CARPINTERIA, CA 93013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DAUM MRI/CONVENTIONAL BIOPSY KIT
DAUM GMBH 510(k) NO: K991366(TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 410-451-0639
P.O. BOX 4341 SE DECISION MADE: 25-JUN-99
CROFTON, MD 21114 510(k) STATEMENT
DEVICE: BARD SPERMA-TEX PRESHAPED MESH (2.4"X5.6"), MODEL 0114700
DAVOL, INC., SUB. C.R. BARD, INC. 510(k) NO: K991637(TRADITIONAL)
ATTN: RINI GEORGEKUTTY PHONE NO : 401-463-7000
100 SOCKANOSSETT CROSSROAD SE DECISION MADE: 22-JUN-99
CRANSTON, RI 02920 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PUMP SEGMENT RINSE LINE W/ SLIP-ON CONNECTOR, PUMP SEGMENT RINSE
DAYSPRING MEDICAL, INC. 510(k) NO: K991003(TRADITIONAL)
ATTN: NEIL RASMUSSEN PHONE NO : 303-442-4514
1936 BEACON CT. SE DECISION MADE: 09-JUN-99
BOULDER, CO 80302 510(k) STATEMENT
DEVICE: VENTED DIAKYSATE PORT CCAP, RED PLIABLE VINYL - DAYSPRING MEDICA
DAYSPRING MEDICAL, INC. 510(k) NO: K991005(TRADITIONAL)
ATTN: NEIL RASMUSSEN PHONE NO : 303-442-4514
1936 BEACON CT. SE DECISION MADE: 22-JUN-99
BOULDER, CO 80302 510(k) STATEMENT
DEVICE: P.F.C. SIGMA POROUS MODULAR KEEL TIBIAL TRAY
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K991106(TRADITIONAL)
ATTN: JANET G JOHNSON PHONE NO : 219-267-8143
700 ORTHOPAEDIC DR. SE DECISION MADE: 09-JUN-99
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING
DERMAPHYLYX, INC. 510(k) NO: K991061(TRADITIONAL)
ATTN: ANDREW M REED PHONE NO : 781-933-4772
78-E,, OLYMPIA AVENUE SE DECISION MADE: 28-JUN-99
WOBURN, MA 01801-3933 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTACHOICE INSTRUMENTS
DEXIDE, INC. 510(k) NO: K991814(SPECIAL)
ATTN: JOHN CORZINE PHONE NO : 817-589-1454
7509 FLAGSTONE DR. SE DECISION MADE: 23-JUN-99
FORT WORTH, TX 76118-6995 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMULITE TURBO TROPONIN I, MODELS LSKTI1, LSKTI5
DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K991795(SPECIAL)
ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200
5700 WEST 96TH ST. SE DECISION MADE: 09-JUN-99
LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5
DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K991796(SPECIAL)
ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200
5700 WEST 96TH ST. SE DECISION MADE: 09-JUN-99
LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5
DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K991797(SPECIAL)
ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200
5700 WEST 96TH ST. SE DECISION MADE: 09-JUN-99
LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DSL ACTIVE AFP ELISA, MODEL DSL-10-8400
DIAGNOSTIC SYSTEMS LABORATORIES, I510(k) NO: K990138(TRADITIONAL)
ATTN: JOHN CLASS PHONE NO : 281-332-9678
445 MEDICAL CENTER BLVD. SE DECISION MADE: 21-JUN-99
WEBSTER, TX 77598 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COPALIS MULTIPLEX EBV ANTIBODY ASSAY
DIASORIN INC. 510(k) NO: K991660(TRADITIONAL)
ATTN: JUDITH J SMITH PHONE NO : 301-497-0005
9175 GUIFORD ROAD SE DECISION MADE: 04-JUN-99
COLUMBIA, MD 21046 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIXION INTRAMEDULLARY NAILING SYSTEM
DISCO-O-TECH MEDICAL TECHNOLOGIES,510(k) NO: K990717(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5600
COLUMBIA SQUARE SE DECISION MADE: 02-JUN-99
555 THIRTEENTH STREET, NW 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20004-1109
DEVICE: DAHEDI INSULIN INFUSION PUMP
DISETRONIC MEDICAL SYSTEMS 510(k) NO: K991376(TRADITIONAL)
ATTN: PATRIK DE HAES PHONE NO : 612-571-6878
7690 CAMERON CIRCLE SE DECISION MADE: 15-JUN-99
FORT MYERS, FL 33912 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRG TITANIUM BONE PLATE
DOCTOR'S RESEARCH GROUP, INC. 510(k) NO: K990920(TRADITIONAL)
ATTN: RICHARD DESLAURIERS PHONE NO : 203-879-9422
143 WOLCOTT RD. SE DECISION MADE: 10-JUN-99
WOLCOTT, CT 06716 510(k) STATEMENT
DEVICE: DORNIER LASERTRODE FIBER
DORNIER SURGICAL PRODUCTS, INC. 510(k) NO: K991183(TRADITIONAL)
ATTN: CAROL WERNECKE PHONE NO : 770-426-1315
1155 ROBERTS BLVD. SE DECISION MADE: 09-JUN-99
KENNESAW, GA 30144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INDEPENDENCE 624
EAGLE PARTS AND PRODUCTS, INC. 510(k) NO: K990122(TRADITIONAL)
ATTN: CHARLES B WALKER JR. PHONE NO : 706-729-9911
1811 WILKINSON RD. SE DECISION MADE: 25-JUN-99
AUGUSTA, GA 30904 510(k) STATEMENT
DEVICE: INDEPENDENCE 324
EAGLE PARTS AND PRODUCTS, INC. 510(k) NO: K990484(TRADITIONAL)
ATTN: CHARLES B WALKER PHONE NO : 706-729-9911
1811 WILKINSON RD. SE DECISION MADE: 25-JUN-99
AUGUSTA, GA 30904 510(k) STATEMENT
DEVICE: LYNX ULTRASOUND SYSTEM
ECTON, INC. 510(k) NO: K991872(TRADITIONAL)
ATTN: CHRISTOPHER B KNELL PHONE NO : 215-283-1800
110 WEST BUTLER AVENUE SE DECISION MADE: 16-JUN-99
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
AMBLER, PA 19002
DEVICE: DIFOTI SYSTEM
ELECTRO-OPTICAL SCIENCES, INC 510(k) NO: K991098(TRADITIONAL)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552
5 WHITCOMB AVE SE DECISION MADE: 30-JUN-99
AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 1000
ELECTROMED, INC. 510(k) NO: K982889(TRADITIONAL)
ATTN: CHET SIEVERT PHONE NO : 612-932-9387
14920 MINNETONKA IND. ROAD SE DECISION MADE: 01-JUN-99
MINNETONKA, MN 55345 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FOUNDATION POROUS HIP STEM
ENCORE ORTHOPEDICS, INC. 510(k) NO: K991226(TRADITIONAL)
ATTN: DEBBIE DE LOS SANTOS PHONE NO : 512-834-6237
9800 METRIC BLVD. SE DECISION MADE: 01-JUN-99
AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 8MM FORGED CEMENTED STEM
ENCORE ORTHOPEDICS, INC. 510(k) NO: K991227(TRADITIONAL)
ATTN: DEBBIE DE LOS SANTOS PHONE NO : 512-834-6237
9800 METRIC BLVD. SE DECISION MADE: 01-JUN-99
AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION OF ENCORE LINEAR POROUS COATED HIP
ENCORE ORTHOPEDICS, INC. 510(k) NO: K991325(TRADITIONAL)
ATTN: DEBBIE DE LOS SANTOS PHONE NO : 512-834-6237
9800 METRIC BLVD. SE DECISION MADE: 25-JUN-99
AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GRIT BLASTED HUMERAL STEM
ENCORE ORTHOPEDICS, INC. 510(k) NO: K991603(TRADITIONAL)
ATTN: DEBBIE DE LOS SANTOS PHONE NO : 512-834-6237
9800 METRIC BLVD. SE DECISION MADE: 29-JUN-99
AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION BITE
ESPE DENTAL AG 510(k) NO: K991008(TRADITIONAL)
ATTN: ANDREAS PETERMANN PHONE NO : 011 498 1527001395
ESPE PLATZ SE DECISION MADE: 18-JUN-99
SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOPATH ENDOSCOPIC INSTRUMENTS
ETHICON ENDO-SURGERY, INC. 510(k) NO: K984240(ABBREVIATED)
ATTN: JACKIE A STRASSER PHONE NO : 513-786-7978
4545 CREEK ROAD SE DECISION MADE: 22-JUN-99
CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSIGHT MILLENNIUM
FASSTECH 510(k) NO: K990778(TRADITIONAL)
ATTN: LEE BRODY PHONE NO : 781-229-1500
155 MIDDLESEX TURNPIKE SE DECISION MADE: 03-JUN-99
BURLINGTON, MA 01803 510(k) STATEMENT
DEVICE: ORASCOPE
FIBERDENT CORP. 510(k) NO: K991011(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 23-JUN-99
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FOTONA FIDELIS ER:YAG LASER SYSTEM & ACCESSORIES
FOTONA D.D. 510(k) NO: K990243(TRADITIONAL)
ATTN: MOJCA VALJAVEC PHONE NO : 386 611 511215
STEGNE 7, SE DECISION MADE: 09-JUN-99
1210 LJUBLJANA, SLOVENIA 1210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRS
FRESENIUS HEMOTECHNOLOGY, INC. 510(k) NO: K984586(TRADITIONAL)
ATTN: VIRGINIA R SINGER PHONE NO : 925-688-0990
110 MASON CIRCLE SUITE A SE DECISION MADE: 29-JUN-99
CONCORD, CA 94520-1238 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUJI WAVELET COMPRESSION OR FFCOMP IRREVERSIBLE COMPRESSION
FUJI MEDICAL SYSTEMS U.S.A., INC. 510(k) NO: K991257(TRADITIONAL)
ATTN: JOSEPH AZARY PHONE NO : 203-602-3677
419 WEST AVE. SE DECISION MADE: 25-JUN-99
STAMFORD, CT 06902 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GASTRIC AND RECTAL CATHETERS
G & J ELECTRONICS, INC. 510(k) NO: K973844(TRADITIONAL)
ATTN: SAM JUNDLER PHONE NO : 416 733 0528
6 DORNFELL STREET SE DECISION MADE: 04-JUN-99
WILLOWDALE, ONTARIO, CANADA M2R2Y6510(k) STATEMENT
DEVICE: DISTENDER SERIES II BAROSTAT
G & J ELECTRONICS, INC. 510(k) NO: K991288(TRADITIONAL)
ATTN: SAM JUNDLER PHONE NO : 416 733 0528
6 DORNFELL STREET SE DECISION MADE: 08-JUN-99
WILLOWDALE, ONTARIO, CANADA M2R2Y6510(k) STATEMENT
DEVICE: FLUOREX 700 -UV (FLUSILFOCON A), FLUOREX 500-UV (FLUSILFOCON B)
G.T. LABORATORIES, INC. 510(k) NO: K991780(TRADITIONAL)
ATTN: JOHN M SZABOCSIK PHONE NO : 312-553-0828
203 NORTH WABASH AVENUE SE DECISION MADE: 29-JUN-99
SUITE 1200 510(k) SUMMARY AVAILABLE FROM FDA
CHICAGO, IL 60601
DEVICE: FLUOREX ULTRA (FLUSILFOCON E) RIGID GAS PERMEABLE CONTACT LENS
G.T. LABORATORIES, INC. 510(k) NO: K991781(TRADITIONAL)
ATTN: JOHN M SZABOCSIK PHONE NO : 312-553-0828
203 NORTH WABASH AVENUE SE DECISION MADE: 29-JUN-99
SUITE 1200 510(k) SUMMARY AVAILABLE FROM FDA
CHICAGO, IL 60601
DEVICE: HISPEED NX/I CT SCANNER SYSTEM
GE MEDICAL SYSTEMS, INC. 510(k) NO: K991716(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 414-544-3894
P.O. BOX 414 SE DECISION MADE: 18-JUN-99
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYSTEM FIVE/ECHOPAC WITH STRAIN RATE IMAGING
GE VINGMED ULTRASOUND 510(k) NO: K991842(TRADITIONAL)
ATTN: PAUL FREDRIKSEN PHONE NO : 011 473 3021107
P.O. BOX 141 SE DECISION MADE: 11-JUN-99
HORTEN, NORWAY N-3191 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE LOGIQ 500
GENERAL ELECTRIC CO. 510(k) NO: K991611(SPECIAL)
ATTN: ALLEN SCHUH PHONE NO : 414-647-4385
P.O. BOX 414 SE DECISION MADE: 09-JUN-99
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENYX MEDICAL INJECTION NEEDLE
GENYX MEDICAL INC. 510(k) NO: K990996(TRADITIONAL)
ATTN: JUDY F GORDON PHONE NO : 949-454-4177
36 ARGONAUT, SUITE 100 SE DECISION MADE: 18-JUN-99
ALISO VIEJO, CA 92656-1467 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE
GENZYME SURGICAL PRODUCTS CORP. 510(k) NO: K991191(TRADITIONAL)
ATTN: MARY E GRAY PHONE NO : 508-677-6512
600 AIRPORT ROAD SE DECISION MADE: 22-JUN-99
FALL RIVER, MA 02720-4740 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GREINER MINICOLLECT LITHIUM HEPARIN GEL BLOOD COLLECTION TUBE
GREINER MEDITECH, INC. 510(k) NO: K991843(TRADITIONAL)
ATTN: DOUG HARRIS PHONE NO : 410-836-8228
260 GATEWAY DR., SUITE 17A SE DECISION MADE: 25-JUN-99
BEL AIR, MD 21014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331
GUIDANT CORP. 510(k) NO: K991102(TRADITIONAL)
ATTN: STACEY SIMON PHONE NO : 909-914-4527
26531 YNEZ RD. SE DECISION MADE: 09-JUN-99
TEMECULA, CA 92591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GYRUS ENDOUROLOGY SYSTEM
GYRUS MEDICAL LTD. 510(k) NO: K990628(TRADITIONAL)
ATTN: DAVID KAY PHONE NO : 440 122 2300100
ST. MELLONS SE DECISION MADE: 29-JUN-99
CARDIFF, UNITED KINGDOM CF3 OLT 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MALE NATURAL RUBBER LATEX CONDOM (WITH LUBRICATION)
HARDCOVER PRODUCTS INC. 510(k) NO: K990925(ABBREVIATED)
ATTN: GERRY GLAZER PHONE NO : 905 660 8700
55 ADMINISTRATION RD., UNIT 12 SE DECISION MADE: 17-JUN-99
CONCORD, ONTARIO, CANADA L4K 4G9 510(k) STATEMENT
DEVICE: HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE)
HARDCOVER PRODUCTS INC. 510(k) NO: K991047(ABBREVIATED)
ATTN: GERRY PERSON PHONE NO : 905 660 8700
55 ADMINISTRATION RD., UNIT 12 SE DECISION MADE: 18-JUN-99
CONCORD, ONTARIO, CANADA L4K 4G9 510(k) STATEMENT
DEVICE: SELF CURE COMPOSITE
HARRY J. BOSWORTH CO. 510(k) NO: K991488(TRADITIONAL)
ATTN: MILDRED M GOLDSTEIN PHONE NO : 847-679-3400
7227 NORTH HAMLIN AVE. SE DECISION MADE: 21-JUN-99
SKOKIE, IL 60076 510(k) STATEMENT
DEVICE: FLC COMPOSITE
HARRY J. BOSWORTH CO. 510(k) NO: K991491(TRADITIONAL)
ATTN: MILDRED M GOLDSTEIN PHONE NO : 847-679-3400
7227 NORTH HAMLIN AVE. SE DECISION MADE: 21-JUN-99
SKOKIE, IL 60076 510(k) STATEMENT
DEVICE: POLYSLIT IFE KIT
HELENA LABORATORIES 510(k) NO: K990998(TRADITIONAL)
ATTN: PAT FRANKS PHONE NO : 800-231-5663
1530 LINDBERGH DR. SE DECISION MADE: 28-JUN-99
PO BOX 752 510(k) STATEMENT
BEAUMONT, TX 77704
DEVICE: BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS
HELIX MEDICAL, INC. 510(k) NO: K991587(TRADITIONAL)
ATTN: CYNTHIA ANDERSON PHONE NO : 805-684-3304
1110 MARK AVE. SE DECISION MADE: 25-JUN-99
CARPINTERIA, CA 93013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: K-SYSTEMS WORK STATIONS, TYPE L-13W, L-13E, L-13ES, L-13ET, L-13
HENNING KNUDSEN ENGINEERING A/S 510(k) NO: K991229(TRADITIONAL)
ATTN: JACOB MOLLENBACH PHONE NO : 454 594 0440
KLINTEHOJ VAENGE 1 SE DECISION MADE: 29-JUN-99
BIRKEROD, DENMARK DK-3460 510(k) STATEMENT
DEVICE: XANTOPREN COMFORT
HERAEUS KULZER, INC. 510(k) NO: K991425(TRADITIONAL)
ATTN: CHERYL V ZIMMERMAN PHONE NO : 219-299-6662
4315 SOUTH LAFAYETTE BLVD. SE DECISION MADE: 15-JUN-99
SOUTH BEND, IN 46614-2517 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP
HEWLETT-PACKARD GMBH 510(k) NO: K991773(SPECIAL)
ATTN: EGON PFEIL PHONE NO : 703-114-2243
HERRENBERGER STR. 110-140 SE DECISION MADE: 07-JUN-99
BOEBLINGEN, GERMANY 71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONVERGENCE NUA FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS
HITACHI MEDICAL CORP. OF AMERICA 510(k) NO: K991318(TRADITIONAL)
ATTN: GARY W ENOS PHONE NO : 330-405-3330
9177 DUTTON DR. SE DECISION MADE: 18-JUN-99
TWINSBURG, OH 44056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEONICS SPINAL SYSTEM VERSATILE CROSS CONNECTOR
HOWMEDICA OSTEONICS CORP. 510(k) NO: K990922(TRADITIONAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-760-8187
59 ROUTE 17 SE DECISION MADE: 02-JUN-99
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEONICS ALUMINA C-TAPER HEAD, OSTEONICS TRIDENT POLYETHYLENE I
HOWMEDICA OSTEONICS CORP. 510(k) NO: K991952(SPECIAL)
ATTN: MARYBETH NAUGHTON PHONE NO : 201-934-4376
59 ROUTE 17 SE DECISION MADE: 29-JUN-99
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOMEPUMP C-SERIES AND HOMEPUMP C-SERIES ONE-STEP KVO
I-FLOW CORP. 510(k) NO: K991513(TRADITIONAL)
ATTN: ROBERT J BARD PHONE NO : 949-206-2700
20202 WINDROW DR. SE DECISION MADE: 21-JUN-99
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PANATOME
IMAGING SCIENCES INTL., INC. 510(k) NO: K991518(TRADITIONAL)
ATTN: ROBERT E HAY PHONE NO : 215-997-5666
1910 NORTH PENN RD. SE DECISION MADE: 18-JUN-99
HATFIELD, PA 19440 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501
IMAGYN MEDICAL TECHNOLOGIES, INC. 510(k) NO: K991526(SPECIAL)
ATTN: CHERYL BLAKE PHONE NO : 714-708-7748
3050 REDHILL AVE. SE DECISION MADE: 17-JUN-99
COSTA MESA, CA 92626 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMPLEX RADIAL HEAD REPLACEMENT SYSTEM
IMPLEX CORP. 510(k) NO: K984290(TRADITIONAL)
ATTN: JOHN SCHALAGO PHONE NO : 201-818-1800
80 COMMERCE DR. SE DECISION MADE: 01-JUN-99
ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMPLEX ALUMINA FEMORAL HEAD
IMPLEX CORP. 510(k) NO: K990183(TRADITIONAL)
ATTN: ROBERT POGGIE PHONE NO : 201-818-1800
80 COMMERCE DR. SE DECISION MADE: 11-JUN-99
ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMTEC BIOPIN
IMTEC CORP. 510(k) NO: K982951(TRADITIONAL)
ATTN: M.K. PATTERSON PHONE NO : 405-223-4456
2401 NORTH COMMERCE SE DECISION MADE: 21-JUN-99
ARDMORE, OK 73401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INVIGRA
INDUS MEDICARE LTD. 510(k) NO: K991374(ABBREVIATED)
ATTN: P.K. REDDY PHONE NO : 914 077 60241
144, S.P. RD., BEGUMPET SE DECISION MADE: 15-JUN-99
HYDERABAD ANDHRA PRADESH, INDIA 50510(k) STATEMENT
DEVICE: METRA PS PROCEDURE KIT
INLET MEDICAL, INC. 510(k) NO: K984600(TRADITIONAL)
ATTN: MARK STERRETT PHONE NO : 502-634-5900
2400 CRITTENDEN DRIVE SE DECISION MADE: 03-JUN-99
LOUISVILLE, KY 40217 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTA LITE ANA ELISA
INOVA DIAGNOSTICS, INC. 510(k) NO: K991657(TRADITIONAL)
ATTN: BRYS C MYERS PHONE NO : 619-586-9900
10180 SCRIPPS RANCH BLVD. SE DECISION MADE: 17-JUN-99
SAN DIEGO, CA 92131 510(k) STATEMENT
DEVICE: FRAMELESS NEUROMATE
INTEGRATED SURGICAL SYSTEMS, INC. 510(k) NO: K991081(TRADITIONAL)
ATTN: R.D. HIBBERT PHONE NO : 530-792-2600
1850 RESEARCH PARK DR. SE DECISION MADE: 25-JUN-99
DAVIS, CA 95616 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DOSE CALC, MODEL VS. 1.02
INTEGRITY MEDICAL SOFTWARE, INC. 510(k) NO: K990833(TRADITIONAL)
ATTN: CRAIG A LAUGHTON PHONE NO : 903-595-0209
403 MOCKINGBIRD LANE SE DECISION MADE: 08-JUN-99
TYLER, TX 75701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERSOURCE 125, MODEL 1251L
INTERNATIONAL BRACHYTHERAPY, INC. 510(k) NO: K984235(TRADITIONAL)
ATTN: RUTH FEICHT PHONE NO : 770-582-0662
6000 LIVE OAK PARKWAY, SE DECISION MADE: 09-JUN-99
SUITE 107 510(k) SUMMARY AVAILABLE FROM FDA
NORCROSS, GA 30093
DEVICE: SYNERGY ADJUSTABLE LENGTH ROD
INTERPORE CROSS INTL. 510(k) NO: K990057(TRADITIONAL)
ATTN: LYNN M RODARTI PHONE NO : 949-453-3200
181 TECHNOLOGY DR. SE DECISION MADE: 28-JUN-99
IRVINE, CA 92618-2402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEAR-GUARD II, CLEAR-THERM HMEF, CLEAR-THERM HMEF W/ FLEXTUBE,
INTERSURGICAL, INC. 510(k) NO: K990949(TRADITIONAL)
ATTN: THOMAS R GUNERMAN PHONE NO : 315-451-2900
417 ELECTRONICS PKWY. SE DECISION MADE: 15-JUN-99
LIVERPOOL, NY 13088 510(k) STATEMENT
DEVICE: INTRACOIL PERIPHERAL STENT
INTRATHERAPEUTICS, INC. 510(k) NO: K990221(TRADITIONAL)
ATTN: AMY PETERSON PHONE NO : 612-937-0322
6271 BURY DR. SE DECISION MADE: 02-JUN-99
EDEN PRAIRIE, MN 55436 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARROW FWD POWER WHEELCHAIR
INVACARE CORP. 510(k) NO: K991168(TRADITIONAL)
ATTN: EDWARD A KROLL PHONE NO : 440-329-6595
1200 TAYLOR STREET SE DECISION MADE: 25-JUN-99
ELYRIA, OH 44036 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: "ORTHOGONAL EP CATHETERS"
IRVINE BIOMEDICAL, INC. 510(k) NO: K990958(SPECIAL)
ATTN: ROGER TU PHONE NO : 949-851-3053
2146-A MICHELSON DR. SE DECISION MADE: 03-JUN-99
IRVINE, CA 92612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOSCOPIC FIBEROPTIC CABLE
ISOLUX AMERICA 510(k) NO: K991208(TRADITIONAL)
ATTN: STUART L MCGHEE PHONE NO : 941-514-7475
1479 RAILHEAD BLVD. SE DECISION MADE: 23-JUN-99
NAPLES, FL 34110-8444 510(k) STATEMENT
DEVICE: JELTEMP
J.F. JELENKO & CO., INC. 510(k) NO: K991564(TRADITIONAL)
ATTN: RAPHAEL JUDKINS PHONE NO : 800-431-1785
99 BUSINESS PARK DR. SE DECISION MADE: 23-JUN-99
ARMONK, NY 10504 510(k) STATEMENT
DEVICE: ASH ADVANTAGE PERITONEAL CATHETER
JANIN GROUP, INC. 510(k) NO: K991042(TRADITIONAL)
ATTN: JOHN A NAVIS PHONE NO : 630-585-1991
615 ENTERPRISE ST. SE DECISION MADE: 25-JUN-99
AURORA, IL 60504-8138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WRIST TYPE DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-303S
JAWON MEDICAL CO., LTD. 510(k) NO: K991688(TRADITIONAL)
ATTN: ROBERT D WAXHAM PHONE NO : 757-365-0978
222 INSTITUTE ST. SE DECISION MADE: 01-JUN-99
SMITHFIELD, VA 23430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIRECT HDL-CHOLESTEROL REAGENT
KAMIYA BIOMEDICAL CO. 510(k) NO: K990581(TRADITIONAL)
ATTN: COLIN GETTY PHONE NO : 206-575-8068
910 INDUSTRY DR. SE DECISION MADE: 18-JUN-99
SEATTLE, WA 98188-3412 510(k) STATEMENT
DEVICE: K-ASSAY MICROALBUMIN CALIBRATOR SET
KAMIYA BIOMEDICAL CO. 510(k) NO: K991166(TRADITIONAL)
ATTN: COLIN GETTY PHONE NO : 206-565-8066
910 INDUSTRY DR. SE DECISION MADE: 10-JUN-99
SEATTLE, WA 98188-3412 510(k) STATEMENT
DEVICE: K-ASSAY RHEUMATOID FACTOR
KAMIYA BIOMEDICAL CO. 510(k) NO: K991409(TRADITIONAL)
ATTN: COLIN GETTY PHONE NO : 206-575-8068
910 INDUSTRY DR. SE DECISION MADE: 09-JUN-99
SEATTLE, WA 98188-3412 510(k) STATEMENT
DEVICE: K-ASSAY RHEUMATOID FACTOR CALIBRATOR SET
KAMIYA BIOMEDICAL CO. 510(k) NO: K991467(TRADITIONAL)
ATTN: COLIN GETTY PHONE NO : 206-575-8068
910 INDUSTRY DR. SE DECISION MADE: 10-JUN-99
SEATTLE, WA 98188-3412 510(k) STATEMENT
DEVICE: DCI ENDOSCOPE
KARL STORZ ENDOSCOPY 510(k) NO: K991171(TRADITIONAL)
ATTN: KEVIN A KENNAN PHONE NO : 800-421-0837
600 CORPORATE POINTE SE DECISION MADE: 23-JUN-99
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DCI ENDOSCOPE
KARL STORZ ENDOSCOPY 510(k) NO: K991228(TRADITIONAL)
ATTN: KEVIN KENNAN PHONE NO : 310-410-2769
600 CORPORATE POINTE SE DECISION MADE: 23-JUN-99
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KSEA EPIDUROSCOPE
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K991051(TRADITIONAL)
ATTN: KEVIN KENNAN PHONE NO : 310-410-2769
600 CORPORATE POINTE SE DECISION MADE: 01-JUN-99
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KSEA NEURO-FIBERSCOPE
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K991069(TRADITIONAL)
ATTN: KEVIN KENNAN PHONE NO : 310-410-2769
600 CORPORATE POINTE SE DECISION MADE: 03-JUN-99
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEM
KARL STORZ IMAGING, INC. 510(k) NO: K990154(TRADITIONAL)
ATTN: TERRY FERNANDEZ PHONE NO : 805-968-5563
175 CREMONA DR. SE DECISION MADE: 01-JUN-99
GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONOJECT INSULIN SYRINGE
KENDALL CO. 510(k) NO: K991758(ABBREVIATED)
ATTN: FRANK J FUCILE PHONE NO : 508-261-8532
15 HAMPSHIRE STREET SE DECISION MADE: 14-JUN-99
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XK-95 HIGH SPEED MOTOR DRILL SYSTEM
KOMET MEDICAL 510(k) NO: K984035(TRADITIONAL)
ATTN: COURTNEY S PARADICE PHONE NO : 770-355-9980
1679 KELLOGG SPRINGS DRIVE SE DECISION MADE: 03-JUN-99
ATLANTA, GA 30338 510(k) STATEMENT
DEVICE: KONICA SRX- 701 AUTOMATIC X-RAY FILM PROCESSOR
KONICA MEDICAL CORP. 510(k) NO: K990969(TRADITIONAL)
ATTN: RUSSELL D MUNVES PHONE NO : 212-490-4100
THE CHRYSLER BUILDING SE DECISION MADE: 18-JUN-99
405 LEXINGTON AVENUE 510(k) STATEMENT
NEW YORK, NY 10174
DEVICE: HOC SET WITH VALVE, HOC SET WITHOUT VALVE, HOC SET WITH VALVE -
LABORATOIRES PRODIMED 510(k) NO: K990913(TRADITIONAL)
ATTN: RANDOLPH L COOKE PHONE NO : 609-466-0510
23 WELISEWITZ RD. SE DECISION MADE: 08-JUN-99
RINGOES, NJ 08551 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LAGLOVE BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDERED CONTA
LAGLOVE (M) SDN. BHD. 510(k) NO: K991748(TRADITIONAL)
ATTN: G. BASKARAN PHONE NO : 603 833 5411
LOT 478, JALAN SIMPANG BALAK, SE DECISION MADE: 23-JUN-99
OFF BATU 13, JALAN CHERAS 510(k) STATEMENT
KAJANG, SELANGOR, D.E., MALAYSIA 43000
DEVICE: LAGLOVE BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDER FREE CO
LAGLOVE (M) SDN. BHD. 510(k) NO: K991749(TRADITIONAL)
ATTN: G. BASKARAN PHONE NO : 603 833 5054
LOT 478, JALAN SIMPANG BALAK, SE DECISION MADE: 23-JUN-99
OFF BATU 13, JALAN CHERAS 510(k) STATEMENT
KAJANG, SELANGOR, D.E., MALAYSIA 43000
DEVICE: COOLTOUCH "V" ND:YAG
LASER AESTHETICS, INC. 510(k) NO: K983984(TRADITIONAL)
ATTN: JONATHAN M BAUMGARDNER PHONE NO : 530-823-1434
11802 KEMPER ROAD SE DECISION MADE: 07-JUN-99
AUBURN, CA 95603 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEICA AT550
LEICA MICROSYSTEMS, INC. 510(k) NO: K990869(TRADITIONAL)
ATTN: FRANK J DREXELIUS PHONE NO : 716-686-4548
3374 WALDEN AVE. SE DECISION MADE: 07-JUN-99
DEPEW, NY 14043 510(k) STATEMENT
DEVICE: PILLOWPOSITIVE CERVICAL PILLOW
LIFESLEEP SYSTEMS, INC. 510(k) NO: K990871(TRADITIONAL)
ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5813
555 THIRTEENTH STREET, N.W. SE DECISION MADE: 10-JUN-99
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THYROCHEK ONE-STEP WHOLE BLOOD RAPID TSH ASSAY
LITTLE NELL LABS, INC. 510(k) NO: K990658(TRADITIONAL)
ATTN: JOEL R. L. EHRENKRANZ PHONE NO : 970-927-5253
1676 EAST SOPRIS CREEK RD. SE DECISION MADE: 02-JUN-99
BASALT, CO 81621 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LONGPORT MODEL LDS -1
LONGPORT, INC. 510(k) NO: K990238(TRADITIONAL)
ATTN: MICHAEL G FARROW PHONE NO : 202-223-0298
1625 K STREET, NW SE DECISION MADE: 23-JUN-99
SUITE 1000 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20006-1604
DEVICE: HEALTH + AID PREMIUM POWDER FREE NITRILE EXAMINATION GLOVES, BLU
M.R.G. INDUSTRIES SDN. BHD. 510(k) NO: K991304(TRADITIONAL)
ATTN: CHONG ENG LIM PHONE NO : 605 891 1111
PT. 4004 KAMUNTING IND. ESTATE SE DECISION MADE: 23-JUN-99
P.O. BOX 9 510(k) SUMMARY AVAILABLE FROM FDA
KAMUNTING, PERAK, MALAYSIA 34600
DEVICE: HEALTH + AID PREMIUM POWDER FREE LATEX EXAMINATION GLOVES
M.R.G. INDUSTRIES SDN. BHD. 510(k) NO: K991305(TRADITIONAL)
ATTN: CHONG ENG LIM PHONE NO : 605 891 1111
PT. 4004 KAMUNTING IND. ESTATE SE DECISION MADE: 21-JUN-99
P.O. BOX 9 510(k) SUMMARY AVAILABLE FROM FDA
KAMUNTING, PERAK, MALAYSIA 34600
DEVICE: MAERSK MEDICAL CONTOUR INFUSION SET
MAERSK MEDICAL A/S 510(k) NO: K991759(TRADITIONAL)
ATTN: DON SELVEY PHONE NO : 520 527 0107
12744 SAN FERNANDO ROAD SE DECISION MADE: 25-JUN-99
SYLMAR, CA 91342 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MASIMO SET 2000 PULSE OXIMETER, MASIMO LNOP -ADT-ADULT/PEDIATRIC
MASIMO CORP. 510(k) NO: K990966(TRADITIONAL)
ATTN: JAMES J CRONIN PHONE NO : 949-250-9688
2852 KELVIN AVE. SE DECISION MADE: 07-JUN-99
IRVINE, CA 92614-5826 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MCKINLEY SP DISPOSABLE INFUSION PUMP
MCKINLEY, INC. 510(k) NO: K990461(TRADITIONAL)
ATTN: JOHN MCINROY PHONE NO : 303-420-9569
4080 YOUNGFIELD ST. SE DECISION MADE: 30-JUN-99
WHEAT RIDGE, CO 80033 510(k) STATEMENT
DEVICE: MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC C
MEDAMICUS, INC. 510(k) NO: K990705(TRADITIONAL)
ATTN: DENNIS S MADISON PHONE NO : 612-559-2613
15301 HWY. 55 WEST SE DECISION MADE: 28-JUN-99
MINNEAPOLIS, MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: METACARPAL FIXATION SYSTEM
MEDCANICA, INC. 510(k) NO: K991064(TRADITIONAL)
ATTN: AL WEISENBORN PHONE NO : 305-829-3437
19526 EAST LAKE DRIVE SE DECISION MADE: 23-JUN-99
MIAMI, FL 33015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: `INEAR WRIST COIL, MODEL 440GE-09
MEDICAL ADVANCES, INC. 510(k) NO: K991113(TRADITIONAL)
ATTN: THOMAS E TYNES PHONE NO : 414-258-3808
10437 INNOVATION DR. SE DECISION MADE: 10-JUN-99
MILWAUKEE, WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LINEAR SHOULDER COIL, MODEL 414GE-09
MEDICAL ADVANCES, INC. 510(k) NO: K991115(TRADITIONAL)
ATTN: THOMAS E TYNES PHONE NO : 414-258-3808
10437 INNOVATION DR. SE DECISION MADE: 08-JUN-99
MILWAUKEE, WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 11.5F X 6" (15CM) DUO-SPLIT CATHETER MCDS116MT, 11.5F X 8" (20CM
MEDICAL COMPONENTS, INC. 510(k) NO: K980438(TRADITIONAL)
ATTN: JEANNE M CUSH PHONE NO : 215-256-4201
1499 DELP DR. SE DECISION MADE: 10-JUN-99
HARLEYSVILLE, PA 19438 510(k) STATEMENT
DEVICE: SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 12CM, SOFT-LINE IJ D
MEDICAL COMPONENTS, INC. 510(k) NO: K983511(TRADITIONAL)
ATTN: JEANNE M CUSH PHONE NO : 215-256-4201
1499 DELP DR. SE DECISION MADE: 08-JUN-99
HARLEYSVILLE, PA 19438 510(k) STATEMENT
DEVICE: PRONTO DRY
MEDICAL INSTRUMENTS CORPORATION MI510(k) NO: K991248(TRADITIONAL)
ATTN: JOHN C MATHERLY PHONE NO : 413 262 34355
FRIEDHOFPLATZ 16 SE DECISION MADE: 22-JUN-99
SOLOTHURN, SWITZERLAND 4502 510(k) STATEMENT
DEVICE: CLIMAX
MEDILATEX SDN. BHD. 510(k) NO: K991049(TRADITIONAL)
ATTN: LEE KIM LANG PHONE NO : 607 896 1888
LOT PTB 500, PERINDUSTRIAN SE DECISION MADE: 15-JUN-99
PKT2, BANDAR TENGGARA 510(k) STATEMENT
KULAI, JOHOR, MALAYSIA 81000
DEVICE: MEDIPOINT
MEDIPOINT LTD. 510(k) NO: K982961(TRADITIONAL)
ATTN: JULES T MITCHEL PHONE NO : 212-681-2100
305 MADISON AVENUE, SUITE 2501 SE DECISION MADE: 07-JUN-99
NEW YORK, NY 10165 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTEXX POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL
MEDTEXX INDUSTRIES (THAI) CO. LTD.510(k) NO: K991153(TRADITIONAL)
ATTN: STEPHEN TAN CKENG KIM PHONE NO : 661 230 3606
200 MU4, TAMBUN TACHANG SE DECISION MADE: 21-JUN-99
AMPHUR BANGKLAM 510(k) SUMMARY AVAILABLE FROM FDA
SONGKHLA, THAILAND 90110
DEVICE: MODIFICATION TO COMPUTERIZED CATHETERIZATION LABORATORY - HORIZO
MENNEN MEDICAL, INC. 510(k) NO: K991775(SPECIAL)
ATTN: KENNETH RAICHMAN PHONE NO : 972 893 83030
KIRYAT WEIZMANN SE DECISION MADE: 24-JUN-99
P.O. BOX 102 510(k) SUMMARY AVAILABLE FROM FDA
ROHOVOT, ISRAEL 76100
DEVICE: PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST
MERIDIAN DIAGNOSTICS, INC. 510(k) NO: K984343(TRADITIONAL)
ATTN: ALAN NICHOL PHONE NO : 513-271-3700
3471 RIVER HILLS DR. SE DECISION MADE: 25-JUN-99
CINCINNATI, OH 45244 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST
MERIDIAN DIAGNOSTICS, INC. 510(k) NO: K984346(TRADITIONAL)
ATTN: ALAN NICHOL PHONE NO : 513-271-3700
3471 RIVER HILLS DR. SE DECISION MADE: 25-JUN-99
CINCINNATI, OH 45244 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FOUNTAIN INFUSION SYSTEM
MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K991619(SPECIAL)
ATTN: CHESTER MCCOY PHONE NO : 801-253-1600
1600 WEST MERIT PKWY. SE DECISION MADE: 09-JUN-99
SOUTH JORDAN, UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHADOW TRAYS
MICK RADIO-NUCLEAR INSTRUMENTS, IN510(k) NO: K991107(TRADITIONAL)
ATTN: FELIX MICK PHONE NO : 718-597-3999
1470 OUTLOOK AVE. SE DECISION MADE: 29-JUN-99
BRONX, NY 10465 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROELECTROENCEPHALOGRAPHY PROFESSIONAL SYSTEM 5000 (EEG PRO SY
MICRORECORDING SYSTEMS CONSULTANTS510(k) NO: K991077(TRADITIONAL)
ATTN: ROBERT L ROGERS PHONE NO : 626-395-0884
2842 E. FOOTHILL BLVD. SE DECISION MADE: 09-JUN-99
PASADENA, CA 91107 510(k) STATEMENT
DEVICE: ULTRA-SELECT GUIDEWIRE, HYTEK GUIDEWIRE
MICROVENA CORP. 510(k) NO: K991898(SPECIAL)
ATTN: ANGELA MALLERY PHONE NO : 651-777-6700
1861 BUERKLE RD. SE DECISION MADE: 16-JUN-99
WHITE BEAR LAKE, MN 55110-5246 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACTIWATCH-SCORE
MINI-MITTER CO., INC. 510(k) NO: K991033(TRADITIONAL)
ATTN: JACK E MCKENZIE PHONE NO : 800-685-2999
PO BOX 3386 SE DECISION MADE: 23-JUN-99
56885 ENTERPRISE DR. 510(k) SUMMARY AVAILABLE FROM FDA
SUNRIVER, OR 97707
DEVICE: MINIMED 508 INSULIN PUMP
MINIMED TECHNOLOGIES, INC. 510(k) NO: K990801(TRADITIONAL)
ATTN: DON SELVEY PHONE NO : 818-362-5958
12744 SAN FERNANDO ROAD SE DECISION MADE: 08-JUN-99
SYLMAR, CA 91342 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINIMED 407C INFUSION PUMP, MODEL 407C
MINIMED TECHNOLOGIES, INC. 510(k) NO: K991013(TRADITIONAL)
ATTN: DON SELVEY PHONE NO : 818-362-5958
12744 SAN FERNANDO RD. SE DECISION MADE: 23-JUN-99
SYLMAR, CA 91342 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUGITA TITANIUM ANEURYSM CLIP
MIZUHO AMERICA, INC. 510(k) NO: K990202(TRADITIONAL)
ATTN: T.WHIT ATHEY PHONE NO : 301-770-9590
12300 TWINBROOK PARKWAY SE DECISION MADE: 04-JUN-99
SUITE 625 510(k) SUMMARY AVAILABLE FROM FDA
ROCKVILLE, MD 20852
DEVICE: EUCLID REDUCTION AND GUIDANCE SYSTEM
MODULAR CUTTING SYSTEMS INC. 510(k) NO: K991037(TRADITIONAL)
ATTN: ALLEN P SCHLEIN PHONE NO : 203-336-3526
650 CLINTON AVE. SE DECISION MADE: 23-JUN-99
BRIDGEPORT, CT 06605 510(k) STATEMENT
DEVICE: HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL C
MORAX 510(k) NO: K990250(TRADITIONAL)
ATTN: BOREK JANIK PHONE NO : 734-475-2441
13805 WATERLOO ROAD SE DECISION MADE: 18-JUN-99
CHELSEA, MI 48118 510(k) STATEMENT
DEVICE: HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15
MORAX 510(k) NO: K991362(TRADITIONAL)
ATTN: BOREK JANIK PHONE NO : 734-475-2441
13805 WATERLOO ROAD SE DECISION MADE: 21-JUN-99
CHELSEA, MI 48118 510(k) STATEMENT
DEVICE: MTP UROPUMP DISPOSABLE TUBING SET
MTP MEDICAL TECHNICAL PROMOTION GM510(k) NO: K990909(TRADITIONAL)
ATTN: KEVIN KENNAN PHONE NO : 310-410-2769
P.O. BOX 1954 SE DECISION MADE: 09-JUN-99
CULVER CITY, CA 90232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MTP HAMOU ENDOMAT DISPOSABLE TUBING SETS
MTP MEDICAL TECHNICAL PROMOTION GM510(k) NO: K990910(TRADITIONAL)
ATTN: KEVIN KENNAN PHONE NO : 310-410-2769
P.O. BOX 1954 SE DECISION MADE: 03-JUN-99
CULVER CITY, CA 90232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MTP ARTHROPUMP DISPOSABLE TUBING SET
MTP MEDICAL TECHNICAL PROMOTION GM510(k) NO: K990911(TRADITIONAL)
ATTN: KEVIN KENNAN PHONE NO : 310-410-2769
P.O. BOX 1954 SE DECISION MADE: 03-JUN-99
CULVER CITY, CA 90232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MTP EXTRACTION BAG
MTP MEDICAL TECHNICAL PROMOTION GM510(k) NO: K990912(TRADITIONAL)
ATTN: KEVIN KENNAN PHONE NO : 310-410-2769
P.O. BOX 1954 SE DECISION MADE: 09-JUN-99
CULVER CITY, CA 90232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AILEE SUTURES AND AILEE NEEDLES
MYCO MEDICAL SUPPLIES, INC. 510(k) NO: K982646(TRADITIONAL)
ATTN: SANJIV KUMAR PHONE NO : 910-678-0680
101 ROSE VALLEY WOODS DR. SE DECISION MADE: 02-JUN-99
CARY, NC 27513 510(k) STATEMENT
DEVICE: HYDROTONE-THERMAL CAPSULE SYSTEM
NATS CORP. 510(k) NO: K991184(ABBREVIATED)
ATTN: RICHARD C LANZILLOTTO PHONE NO : 516-744-0059
30 NORTHPORT ROAD SE DECISION MADE: 23-JUN-99
SOUND BEACH, NY 11789-1734 510(k) STATEMENT
DEVICE: ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL
NEOMETRICS, INC. 510(k) NO: K991498(TRADITIONAL)
ATTN: DAVID SCHWARTZ PHONE NO : 516-754-8080
104 BELLEROSE AVE. SE DECISION MADE: 16-JUN-99
EAST NORTHPORT, NY 11731 510(k) STATEMENT
DEVICE: UNI-CLIP STAPLE
NEWDEAL S.A. 510(k) NO: K991482(TRADITIONAL)
ATTN: NORMAN F ESTRIN PHONE NO : 301-279-2899
9109 COPENHAVER DRIVE SE DECISION MADE: 03-JUN-99
POTOMAC, MD 20854 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIHON KOHDEN TG-901T CO2 SENSOR KIT WITH ACCESSORIES
NIHON KOHDEN, INC. 510(k) NO: K990063(TRADITIONAL)
ATTN: GARY REASONER PHONE NO : 949-250-3959
2601 CAMPUS DR. SE DECISION MADE: 09-JUN-99
IRVINE, CA 92612-1601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMORPHOUS DIAMOND COATED DRILL
NOBEL BIOCARE USA, INC. 510(k) NO: K990846(TRADITIONAL)
ATTN: KIM RENDON PHONE NO : 714-282-4800
22895 EAST PARK DR. SE DECISION MADE: 10-JUN-99
YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC
NOBELPHARMA USA, INC. 510(k) NO: K984162(TRADITIONAL)
ATTN: BETSY A BROWN PHONE NO : 708-654-9100
777 OAKMONT LANE SE DECISION MADE: 28-JUN-99
WESTMONT, IL 60559 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HAL SCOPE HOLDER SYSTEM
NOVED MEDICAL 510(k) NO: K991548(TRADITIONAL)
ATTN: MIKE GRIFFIN PHONE NO : 714-366-2944
168 AVENIDA DEL MAR, SUITE 120 SE DECISION MADE: 23-JUN-99
SAN CLEMENTE, CA 92672 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET
NSK NAKANISHI, INC. 510(k) NO: K990954(TRADITIONAL)
ATTN: HIROSHI SEKIGUCHI PHONE NO : 028 964 3380
340 KAMIHINATA, KANUMA-SHI SE DECISION MADE: 09-JUN-99
TOCHIGI-KEN, JAPAN 322 510(k) STATEMENT
DEVICE: SONIC SCALER WITH FIBER OPTIC, MODEL NAS-L, SONIC SCALER WITHOUT
NSK NAKANISHI, INC. 510(k) NO: K991021(TRADITIONAL)
ATTN: HIROJI SEKIGUCHI PHONE NO : 028 964 3380
340 KAMIHINATA, KANUMA-SHI SE DECISION MADE: 23-JUN-99
TOCHIGI-KEN, JAPAN 322 510(k) STATEMENT
DEVICE: NORMA 10
ODIN TECHNOLOGIES LTD. 510(k) NO: K991243(TRADITIONAL)
ATTN: ADI ICKOWICZ PHONE NO : 972 495 91010
P.O. BOX 248 SE DECISION MADE: 18-JUN-99
YOKNEAM ELIT, ISRAEL 20698 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEFLECTABLE TAC ELECTROTHERMAL PROBE
ORATEC INTERVENTIONS, INC. 510(k) NO: K990859(TRADITIONAL)
ATTN: SHEILA RAMERMAN PHONE NO : 650-369-9904
3700 HAVEN CT. SE DECISION MADE: 14-JUN-99
MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEFLECTABLE ELECTROSURGICAL PROBES
ORATEC INTERVENTIONS, INC. 510(k) NO: K991190(TRADITIONAL)
ATTN: SHEILA RAMERMAN PHONE NO : 650-369-9904
3700 HAVEN CT. SE DECISION MADE: 23-JUN-99
MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COAG-A-MATE MAX
ORGANON TEKNIKA CORP. 510(k) NO: K991101(TRADITIONAL)
ATTN: REBECCA A RIVAS PHONE NO : 919-620-2288
100 AKZO AVENUE SE DECISION MADE: 01-JUN-99
DURHAM, NC 27712 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORIBRUSH - STANDARD - B002
ORIFICE MEDICAL AB 510(k) NO: K991593(TRADITIONAL)
ATTN: PATRIK NILSSON PHONE NO : 011 464 1165430
BRONSGATAN 12 SE DECISION MADE: 29-JUN-99
YSTAD, SWEDEN S-271 39 510(k) STATEMENT
DEVICE: ORIBRUSH - WITH PROTECTIVE TIP - B001
ORIFICE MEDICAL AB 510(k) NO: K991595(TRADITIONAL)
ATTN: PATRIC NILSSON PHONE NO : 001 464 1165430
BRONSGATAN 12 SE DECISION MADE: 29-JUN-99
YSTAD, SWEDEN S-271 39 510(k) STATEMENT
DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS CEA CALIBRATORS, VITROS IMMUNOD
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K990943(TRADITIONAL)
ATTN: ANNE ZAVERTNIK PHONE NO : 716-453-3790
100 INDIGO CREEK DRIVE SE DECISION MADE: 01-JUN-99
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCUTRED SHOE
ORTHOPEDIC TECHNOLOGY RESEARCH, IN510(k) NO: K991313(TRADITIONAL)
ATTN: CHERYL G DYER PHONE NO : 423-870-7207
4717 ADAMS ROAD SE DECISION MADE: 23-JUN-99
P.O. BOX 489 510(k) STATEMENT
HIXSON, TN 37343
DEVICE: OSTEOMED INTRAORAL DISTRACTION SYSTEM
OSTEOMED CORP. 510(k) NO: K990944(TRADITIONAL)
ATTN: RICK A BUSS PHONE NO : 972-241-3401
3750 REALTY RD. SE DECISION MADE: 16-JUN-99
ADDISON, TX 75001-4311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IDS4 V3.2 IMAGE DISPLAY SYSTEM
OTECH, INC. 510(k) NO: K991643(SPECIAL)
ATTN: HERMAN OOSTERWIJK PHONE NO : 940-440-9530
2001 EAST OAKSHORES DRIVE SE DECISION MADE: 08-JUN-99
CROSSROADS, TX 76227 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PACIFIC HEMOSTASIS THROMBOSCREEN 200
PACIFIC HEMOSTASIS 510(k) NO: K991321(TRADITIONAL)
ATTN: LARRY KOPYTA PHONE NO : 412-490-8816
11515 VANSTORY DR. SE DECISION MADE: 21-JUN-99
HUNTERSVILLE, NC 28078-8144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PSI TITANIUM MICRO-LIGATION HEMOSTATIC CLIP
PACIFIC SURGICAL INNOVATIONS, INC.510(k) NO: K991002(TRADITIONAL)
ATTN: TERRY JOHNSTON PHONE NO : 650-802-6988
360 INDUSTRIAL RD., UNIT H SE DECISION MADE: 11-JUN-99
SAN CARLOS, CA 94070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A P HARNESS
PARAWORKS ENTERPRISE, LTD. 510(k) NO: K981860(TRADITIONAL)
ATTN: MICHAEL C CAMPBELL PHONE NO : 604 871 0040
#1-179 WEST 17TH AVENUE SE DECISION MADE: 03-JUN-99
VANCOUVER, BRITISH COLUMBIA, CANAD510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RC CORNET, MODEL #44F50
PARI RESPIRATORY EQUIPMENT, INC. 510(k) NO: K983308(TRADITIONAL)
ATTN: MIGUEL A ARRIZON PHONE NO : 804-639-7235
13800 HULL ST. RD. SE DECISION MADE: 04-JUN-99
MIDLOTHIAN, VA 23112 510(k) STATEMENT
DEVICE: PASSY-MUIR LOW-PROFILE TRACHEOSTOMY SPEAKING VALVE PMV 2020 (CLE
PASSY-MUIR, INC. 510(k) NO: K990905(TRADITIONAL)
ATTN: PATRICIA E PASSY PHONE NO : 949-833-8255
4521 CAMPUS DR., SUITE 273 SE DECISION MADE: 11-JUN-99
IRVINE, CA 92612 510(k) STATEMENT
DEVICE: O.B. APPLICATOR TAMPONS, O.B. TAMPONS
PERSONAL PRODUCTS CO. 510(k) NO: K991118(TRADITIONAL)
ATTN: RALPH PETRONE PHONE NO : 908-874-1214
199 GRANDVIEW RD. SE DECISION MADE: 29-JUN-99
SKILLMAN, NJ 08558 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERED NITRILE EXAMINATION GLOVE, WHITE (NON-COLORED)
PERUSAHAAN GETAH ASAS SDN BHD 510(k) NO: K991511(TRADITIONAL)
ATTN: TAN KONG CHANG PHONE NO : 603 391 1949
42100 KLANG, SE DECISION MADE: 03-JUN-99
P.O. BOX 188, 41720 KLANG 510(k) STATEMENT
SELANGOR, DARUL EHSAN, MALAYSIA 42100
DEVICE: AT HOME COCAINE & THC SCREENING TEST, MODEL 9170
PHAMATECH 510(k) NO: K991641(SPECIAL)
ATTN: CARL A MONGIOVI PHONE NO : 619-635-5840
9265 ACTIVITY RD., #112-113 SE DECISION MADE: 01-JUN-99
SAN DIEGO, CA 92126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AT HOME DRUG TEST, MODEL 9171
PHAMATECH 510(k) NO: K991824(SPECIAL)
ATTN: CARL A MONGIOVI PHONE NO : 619-635-5840
9265 ACTIVITY RD., #112-113 SE DECISION MADE: 11-JUN-99
SAN DIEGO, CA 92126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MTM BIOSCANNER C TEST STRIPS
POLYMER TECHNOLOGY SYSTEMS, INC. 510(k) NO: K990688(TRADITIONAL)
ATTN: MARGO ENRIGHT PHONE NO : 317-870-5610
7736 ZIONSVILLE ROAD SE DECISION MADE: 24-JUN-99
INDIANAPOLIS, IN 46268 510(k) STATEMENT
DEVICE: CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15
PRECISION BIOLOGIC 510(k) NO: K990814(TRADITIONAL)
ATTN: SANDY MORRISON PHONE NO : 902 468 6422
900 WINDMILL RD., SUITE 100 SE DECISION MADE: 07-JUN-99
DARTMOUTH, N.S., CANADA B3B 1P7 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STATUS CUP ACCUSIGN CUP
PRINCETON BIOMEDITECH CORP. 510(k) NO: K991751(SPECIAL)
ATTN: JEMO KANG PHONE NO : 800-726-2670
4242 U.S. RT. 1 SE DECISION MADE: 18-JUN-99
MONMOUTH JUNCTION, NJ 08852-1905 510(k) STATEMENT
DEVICE: PRODIMED MICROINJECTION PIPETTES
PRODIMED 510(k) NO: K983713(TRADITIONAL)
ATTN: RANDOLPH L COOKE PHONE NO : 609-466-0510
23 WELISEWITZ RD. SE DECISION MADE: 08-JUN-99
RINGOES, NJ 08551 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTASE TOTAL GALACTOSE SCREENING ASSAY
QUANTASE LTD. 510(k) NO: K990644(TRADITIONAL)
ATTN: R. STEWART CAMPBELL PHONE NO : 440 173 8444102
3 RIVERVIEW BUSINESS PARK SE DECISION MADE: 21-JUN-99
FRIARTON ROAD 510(k) STATEMENT
PERTH, SCOTLAND, UNITED KINGDOM PH2 8DF
DEVICE: QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT
QUANTASE LTD. 510(k) NO: K990654(TRADITIONAL)
ATTN: R. STEWART CAMPBELL PHONE NO : 440 173 8444102
3 RIVERVIEW BUSINESS PARK SE DECISION MADE: 21-JUN-99
FRIARTON ROAD 510(k) STATEMENT
PERTH, SCOTLAND, UNITED KINGDOM PH2 8DF
DEVICE: SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATE
R & D SYSTEMS, INC. 510(k) NO: K991876(TRADITIONAL)
ATTN: SUE GALLO PHONE NO : 612-379-2956
614 MCKINLEY PL., N.E. SE DECISION MADE: 17-JUN-99
MINNEAPOLIS, MN 55413 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DERMASTIM PLUS, PIGTAILS, FLEXSTIM SUPERFLEX, FLEXSTIM PLUS, CAR
RAPID MFG. CO. 510(k) NO: K982096(ABBREVIATED)
ATTN: CHARITY MARTIN PHONE NO : 404-696-1113
3800 WENDELL DR. SW SE DECISION MADE: 18-JUN-99
SUITE 204 510(k) STATEMENT
ATLANTA, GA 30336
DEVICE: OVERLANDER PEV 2000
RAYE'S, INC. 510(k) NO: K983497(TRADITIONAL)
ATTN: WILLARD L FRICKEY PHONE NO : 800-537-6454
204 WEST 2ND ST. SE DECISION MADE: 27-JUN-99
ELLIS, KS 67637 510(k) STATEMENT
DEVICE: FLEXIBLE FIBERSCOPE, MODEL 7331.001, GUIDE SECTION FOR LITHOVAC
RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K991178(TRADITIONAL)
ATTN: RPBERT L CASARSA PHONE NO : 847-913-1113
353 CORPORATE WOODS PKWY SE DECISION MADE: 11-JUN-99
VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROCHE COBAS INTEGRA SERUM BARBITURATES
ROCHE DIAGNOSTICS CORP. 510(k) NO: K991440(TRADITIONAL)
ATTN: LISA M GERARD PHONE NO : 317-576-3362
9115 HAGUE RD. SE DECISION MADE: 22-JUN-99
INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROCHE COBAS INTEGRA SERUM BENZODIAZEPINES (SBENZ)
ROCHE DIAGNOSTICS CORP. 510(k) NO: K991443(TRADITIONAL)
ATTN: LISA M GERARD PHONE NO : 317-576-3362
9115 HAGUE RD. SE DECISION MADE: 22-JUN-99
INDIANAPOLIS, IN 46250-0457 510(k) STATEMENT
DEVICE: RS-4V MUSCLE STIMULATOR
RS MEDICAL 510(k) NO: K990697(TRADITIONAL)
ATTN: MIKE MCGRAW PHONE NO : 360-892-0339
P.O. BOX 4656 SE DECISION MADE: 18-JUN-99
VANCOUVER, WA 98662-0656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INVISION-PLUS INJECTION PORT CONNECTOR SYSTEM
RYMED TECHNOLOGIES, INC. 510(k) NO: K991653(TRADITIONAL)
ATTN: AL WEISENBORN PHONE NO : 305-829-3437
19526 EAST LAKE DRIVE SE DECISION MADE: 24-JUN-99
MIAMI, FL 33015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LC MICROFILL
S & C POLYMER GMBH 510(k) NO: K991442(TRADITIONAL)
ATTN: JURGEN ENGELBRECHT PHONE NO : 494 121 8619
ROBERT-BOSCH-STR. 5 SE DECISION MADE: 03-JUN-99
D-25335 510(k) SUMMARY AVAILABLE FROM FDA
ELMSHORN, GERMANY
DEVICE: SURGISORB
SAMYANG CORP. 510(k) NO: K984374(TRADITIONAL)
ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640
200 GREGORY LANE, SUITE C-100 SE DECISION MADE: 04-JUN-99
PLEASANT HILL, CA 94523-3389 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3D ANATOMICAL MESH
SANTERRA MEDICAL TECHNOLOGY, INC. 510(k) NO: K990930(TRADITIONAL)
ATTN: DAVID P LANG PHONE NO : 651-704-9160
5451 HILLTOP AVE. SE DECISION MADE: 17-JUN-99
LAKE ELMO, MN 55042-9539 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SARGON IMMEDIATE LOAD IMPLANT, MODEL D
SARGON ENT., INC. 510(k) NO: K981141(TRADITIONAL)
ATTN: DANIEL J MANELLI PHONE NO : 202-261-1000
2000 M STREET NW #700 SE DECISION MADE: 23-JUN-99
WASHINGTON, DC 20036 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLORPOINT 1720 MEDICAL IMAGERS AND VIDEO CAPTURE BOX CX-1000 SE
SEIKO INSTRUMENTS USA, INC. 510(k) NO: K991282(TRADITIONAL)
ATTN: HERMAN OOSTERWJICK PHONE NO : 940-440-9330
2001 EAST OAKSHORES DR. SE DECISION MADE: 30-JUN-99
CROSSROADS, TX 76227 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHETIC POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES
SHANGHAI INTCO. PLASTIC & RUBBER P510(k) NO: K990186(TRADITIONAL)
ATTN: FRANK LIU PHONE NO : 909-590-9358
13945 MAGNOLIA AVE SE DECISION MADE: 21-JUN-99
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROYAL SHIELD NON-STERILE BUBBLE GUM SCENTED POWDER-FREE LATEX EX
SHIELD GLOVES MANUFACTURER (M) SDN510(k) NO: K991743(TRADITIONAL)
ATTN: E. J. SMITH PHONE NO : 410-451-0639
P.O. BOX 4341 SE DECISION MADE: 23-JUN-99
CROFTON, MD 21114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMART SHIELD NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATION G
SHIELD GLOVES MANUFACTURER (M) SDN510(k) NO: K991744(TRADITIONAL)
ATTN: E. J. SMITH PHONE NO : 410-451-0639
P.O. BOX 4341 SE DECISION MADE: 23-JUN-99
CROFTON, MD 21114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROYAL SHIELD NON-STERILE POWDER-FREE, GREEN LATEX EXAMINATION GL
SHIELD GLOVES MANUFACTURER (M) SDN510(k) NO: K991745(TRADITIONAL)
ATTN: E. J. SMITH PHONE NO : 410-451-0639
P.O. BOX 4341 SE DECISION MADE: 23-JUN-99
CROFTON, MD 21114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROYAL SHIELD POWDER-FREE PINEAPPLE SCENTED LATEX EXAMINATION GLO
SHIELD GLOVES MANUFACTURER (M) SDN510(k) NO: K991746(TRADITIONAL)
ATTN: E. J. SMITH PHONE NO : 410-451-0639
P.O. BOX 4341 SE DECISION MADE: 23-JUN-99
CROFTON, MD 21114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE VINYL EXAMINATION GLOVES
SHIJIAZHUANG BRETHREN PLASTIC CO.,510(k) NO: K983856(TRADITIONAL)
ATTN: XIN-LAI ZHOU PHONE NO : 011 860 3117702144
NO. 37 ZHONGHUA SOUTH STREET SE DECISION MADE: 21-JUN-99
SHIJIAZHUANG, HEBEI, CHINA 510(k) STATEMENT
DEVICE: POWDERED VINYL EXAMINATION GLOVE
SHIJIAZHUANG BRETHREN PLASTIC CO.,510(k) NO: K983893(TRADITIONAL)
ATTN: XIN-LAI ZHOU PHONE NO : 863 117 024360
NO. 37 ZHONGHUA SOUTH STREET SE DECISION MADE: 21-JUN-99
SHIJIAZHUANG, HEBEI, CHINA 510(k) STATEMENT
DEVICE: SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS
SHIMADZU CORP. 510(k) NO: K991553(ABBREVIATED)
ATTN: MICHAEL FISHBACK PHONE NO : 310-217-8855
20101 SOUTH VERMONT AVENUE SE DECISION MADE: 08-JUN-99
TORRANCE, CA 90502-1328 510(k) STATEMENT
DEVICE: SOMATOM PLUS 4 WITH SLIDING GANTRY OPTION
SIEMENS CORP. 510(k) NO: K991600(SPECIAL)
ATTN: ALICIA BUSTOS-JUERGENSEN PHONE NO : 732-321-3243
186 WOOD AVE., SOUTH SE DECISION MADE: 09-JUN-99
ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIEMENS INFINITY EEG POD
SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K991012(TRADITIONAL)
ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500
16 ELECTRONICS AVE. SE DECISION MADE: 24-JUN-99
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CADD-TPN ADMINISTRATION SET, MODEL 21-7071
SIMS DELTEC, INC. 510(k) NO: K991255(TRADITIONAL)
ATTN: EDWARD W NUMAINVILLE PHONE NO : 651-628-7166
1265 GREY FOX RD. SE DECISION MADE: 09-JUN-99
ST. PAUL, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND
SIMS DELTEC, INC. 510(k) NO: K991301(TRADITIONAL)
ATTN: EDWARD W NUMAINVILLE PHONE NO : 651-628-7166
1265 GREY FOX RD. SE DECISION MADE: 09-JUN-99
ST. PAUL, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CADD ADMINISTRATION SET
SIMS DELTEC, INC. 510(k) NO: K991599(TRADITIONAL)
ATTN: EDWARD W NUMAINVILLE PHONE NO : 651-682-7166
1265 GREY FOX RD. SE DECISION MADE: 15-JUN-99
ST. PAUL, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTLIGHT DIGITAL FILM VIEWER, MODELS SL 4000PLUS, SL 2000PLUS
SMARTLIGHT, INC. 510(k) NO: K991302(TRADITIONAL)
ATTN: A. ROBERT SOHOVAL PHONE NO : 201-487-4544
241 MAIN ST. SE DECISION MADE: 01-JUN-99
HACKENSACK, NJ 07601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPERA CUPFLANGED ACETABULAR COMPONENTS
SMITH & NEPHEW, INC., ORTHOPAEDIC 510(k) NO: K991538(ABBREVIATED)
ATTN: JANET JOHNSON GREEN PHONE NO : 901-396-2121
1450 BROOKS RD. SE DECISION MADE: 03-JUN-99
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIVOSONIC
SONOTECH, INC. 510(k) NO: K984562(TRADITIONAL)
ATTN: MARGARET J LARSON PHONE NO : 360-671-9121
774 MARINE DR. SE DECISION MADE: 08-JUN-99
BELLINGHAM, WA 98225 510(k) STATEMENT
DEVICE: SPACELABS MEDICAL ULTRAVIEW DIGITAL TELEMTRY SYSTEM
SPACELABS MEDICAL, INC. 510(k) NO: K983996(TRADITIONAL)
ATTN: NANCY J GERTLAR PHONE NO : 425-867-7315
15220 N.E. 40TH ST. SE DECISION MADE: 03-JUN-99
REDMOND, WA 98073-9713 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIOQUANT CARDIAC ASSESSMENT CONTROLS
SPECTRAL DIAGNOSTICS INC. 510(k) NO: K991447(TRADITIONAL)
ATTN: JOSEPH P LAURINO PHONE NO : 416 626 3233
135-2 THE WEST MALL SE DECISION MADE: 11-JUN-99
TORONTO, ONTARIO, CANADA M9C1C2 510(k) STATEMENT
DEVICE: THERMAL CAUTERY DEVICE, FORCEPS
STARION INSTRUMENTS 510(k) NO: K990728(TRADITIONAL)
ATTN: GEORGE D HERMANN PHONE NO : 087-418-8773
22900 CONGRESS SPRINGS ROAD SE DECISION MADE: 03-JUN-99
SARATOGA, CA 95070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HISTOFREEZER DEVICE
STC TECHNOLOGIES, INC. 510(k) NO: K990877(TRADITIONAL)
ATTN: R. SAM NIEDBALA PHONE NO : 610-882-1820
1745 EATON AVE. SE DECISION MADE: 14-JUN-99
BETHLEHEM, PA 18018 510(k) STATEMENT
DEVICE: STERIS SMOKE EVACUATION SYSTEM
STERIS CORP. 510(k) NO: K991167(ABBREVIATED)
ATTN: ROBERT H MCCALL PHONE NO : 334-277-6660
2720 GUNTER PARK EAST SE DECISION MADE: 03-JUN-99
MONTGOMERY, AL 36109 510(k) STATEMENT
DEVICE: STERI-PAK LF BOWIE-DICK TEST PACK
STERITEC PRODUCTS MFG. CO., INC. 510(k) NO: K990246(TRADITIONAL)
ATTN: LON BRUSO PHONE NO : 303-660-4201
680 ATCHISON WAY, SUITE 600 SE DECISION MADE: 10-JUN-99
CASTLE ROCK, CO 80104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER INFRAVISION ESOPHAGEAL KIT
STRYKER ENDOSCOPY 510(k) NO: K983220(TRADITIONAL)
ATTN: SEAN CAHILL PHONE NO : 408-567-2469
2590 WALSH AVE. SE DECISION MADE: 04-JUN-99
SANTA CLARA, CA 95051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REMOVABLE CUFF ABUTMENT
SULZER CALCITEK INC. 510(k) NO: K984536(TRADITIONAL)
ATTN: FOSTER BOOP PHONE NO : 760-431-9515
2320 FARADAY AVE. SE DECISION MADE: 16-JUN-99
CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGNA-ROM 21 KNEE SYSTEEM
SULZER ORTHOPEDICS, INC. 510(k) NO: K991143(TRADITIONAL)
ATTN: SHAVAWN PARDUHN PHONE NO : 512-432-9360
9900 SPECTRUM DR. SE DECISION MADE: 11-JUN-99
AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMNI-FIX, HUMERAL NAIL
SURGICAL IMPLANTS, INC. 510(k) NO: K991405(TRADITIONAL)
ATTN: DOUGLAS W STUART PHONE NO : 941-366-1882
962 SOUTH TAMIAMI TRAIL, #203 SE DECISION MADE: 29-JUN-99
SARASOTA, FL 34326 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLO ORTHO
SYBRON DENTAL SPECIALTIES INC. 510(k) NO: K990743(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE SE DECISION MADE: 04-JUN-99
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTEC-E IRRIGATION SYSTEM
SYBRON DENTAL SPECIALTIES INC. 510(k) NO: K991035(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE SE DECISION MADE: 24-JUN-99
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND
SYMTEX HEALTHCARE CORP. 510(k) NO: K991215(TRADITIONAL)
ATTN: RICHARD S WANG PHONE NO : 909-468-2186
783 PINEFALLS AVE. SE DECISION MADE: 11-JUN-99
WALNUT, CA 91789 510(k) STATEMENT
DEVICE: SYNTHES QUICK LOCK IMF SYSTEM
SYNTHES (USA) 510(k) NO: K991004(TRADITIONAL)
ATTN: SHERI L MUSGNUNG PHONE NO : 610-647-9700
P.O. BOX 1766, 1690 RUSSELL SE DECISION MADE: 23-JUN-99
ROAD 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19399
DEVICE: SYNTHES LOCKING CALCANEAL PLATES
SYNTHES (USA) 510(k) NO: K991407(TRADITIONAL)
ATTN: SHERI L MUSGNUNG PHONE NO : 610-647-9700
1690 RUSSELL ROAD SE DECISION MADE: 11-JUN-99
POST OFFICE BOX 1766 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301
DEVICE: SYNTHES PEDIATRIC ROD SYSTEM
SYNTHES (USA) 510(k) NO: K991552(SPECIAL)
ATTN: JONATHAN GILBERT PHONE NO : 610-647-9700
P.O. BOX 1766 SE DECISION MADE: 02-JUN-99
1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301-1222
DEVICE: QUIKSTRIP DIPSCAN X MULTIDRUG SCREENING DEVICE
SYNTRON BIORESEARCH, INC. 510(k) NO: K990325(TRADITIONAL)
ATTN: CLEVE W LAIRD PHONE NO : 805-522-6223
1420 LOS ANGELES AVE. SE DECISION MADE: 24-JUN-99
SUITE 201 510(k) SUMMARY AVAILABLE FROM FDA
SIMI VALLEY, CA 93065
DEVICE: AUTODOSE INFUSION SYSTEM
TANDEM MEDICAL, INC. 510(k) NO: K990889(TRADITIONAL)
ATTN: ALBERT MISAJON PHONE NO : 619-673-3900
15910 BERNARDO CENTER DRIVE SE DECISION MADE: 03-JUN-99
SAN DIEGO, CA 92127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TE ME NA LOSS OF RESISTANCE SYRINGE, 10CC
TE ME NA S.A.R.L. 510(k) NO: K990020(TRADITIONAL)
ATTN: DONALD F RYAN PHONE NO : 813-796-6916
21981 U.S. 19N SE DECISION MADE: 24-JUN-99
CLEARWATER, FL 33765 510(k) STATEMENT
DEVICE: K-PACK II (HYPODERMIC NEEDLE) 23G X 1, MODEL KN-2325RB, K-PACK I
TERUMO EUROPE N.V. 510(k) NO: K984576(TRADITIONAL)
ATTN: M J AERTS PHONE NO : 003 216 381211
RESEARCHPARK ZONE 2 SE DECISION MADE: 14-JUN-99
INTERLEUVENLAAN 40 510(k) SUMMARY AVAILABLE FROM FDA
LEUVEN 3001, BELGIUM 3001
DEVICE: CAPIOX CARDIOPLEGIA
TERUMO MEDICAL CORP. 510(k) NO: K982467(TRADITIONAL)
ATTN: SANDI HARTKA PHONE NO : 410-392-7231
125 BLUE BALL ROAD SE DECISION MADE: 23-JUN-99
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TERUMO SURFLO FLEX I.V. CATHETER AND TERUMO SURFLASH I.V. CATHET
TERUMO MEDICAL CORP. 510(k) NO: K991406(TRADITIONAL)
ATTN: KRISTINE WAGNER PHONE NO : 410-392-7241
125 BLUE BALL RD. SE DECISION MADE: 16-JUN-99
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE BLUE NITRILE GLOVE
TG MEDICAL SDN BHD 510(k) NO: K990668(TRADITIONAL)
ATTN: LIM WEE CHAI PHONE NO : 603 392 7880
LOT 5091, JALAN TERATAI, BT 5, SE DECISION MADE: 03-JUN-99
OFF JLN MERU 510(k) STATEMENT
KLANG, SELANGOR D.E., MALAYSIA 41050
DEVICE: SSA-370A/POWERVISION 6000
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K991710(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 03-JUN-99
P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92681-2068
DEVICE: SSA-390A/POWER VISION 8000
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K991858(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 16-JUN-99
P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92681-2068
DEVICE: AIA-PACK CA 125
TOSOH MEDICS, INC. 510(k) NO: K990431(TRADITIONAL)
ATTN: JUDITH E LOEBEL PHONE NO : 650-615-4970
347 OYSTER POINT BLVD., SE DECISION MADE: 03-JUN-99
SUITE 201 510(k) STATEMENT
SOUTH SAN FRANCISCO, CA 94080
DEVICE: ORTHOSLICE OS1000 SERIES; PANORAMIC ORTHOSLICE OS 1000: OS1000,
TROPHY RADIOLOGIE 510(k) NO: K991455(TRADITIONAL)
ATTN: MARIE-PIERRE LABAT-CAMY PHONE NO : 331 648 08500
4 RUE F. PELLOUTIER CROISSY SE DECISION MADE: 25-JUN-99
BEAUBOURG 510(k) STATEMENT
MARNE LA VALLEE CEDEX 2, FRANCE 77437
DEVICE: MODIFICATION TO DIGIPAN
TROPHY RADIOLOGIE 510(k) NO: K991912(TRADITIONAL)
ATTN: MARIR-PIERRE LABAT-CAMY PHONE NO : 331 648 08500
4 RUE F. PELLOUTIER CROISSY SE DECISION MADE: 22-JUN-99
BEABOURG 510(k) STATEMENT
MARNE LA VALLEE CEDEX 2, FRANCE 77437
DEVICE: AUTO SUTURE ABBI SYSTEM
UNITED STATES SURGICAL CORP. 510(k) NO: K983296(TRADITIONAL)
ATTN: CHRISTOPHER A GRAHAM PHONE NO : 203-845-1390
150 GLOVER AVE. SE DECISION MADE: 04-JUN-99
NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEXIDE BIPOLAR FORCEPS II ** DEVICE
UNITED STATES SURGICAL CORP. 510(k) NO: K991859(TRADITIONAL)
ATTN: CHRISTOPHER A GRAHAM PHONE NO : 203-845-1390
150 GLOVER AVE. SE DECISION MADE: 23-JUN-99
NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LATEX EXAMINATION GLOVES (POWDER FREE)
USG HEALTHGUARD SDN BHD 510(k) NO: K991689(TRADITIONAL)
ATTN: TOH CHEE YEONG PHONE NO : 603 635 3882
LOT 2756 JALAN KEMPAS LAMA SE DECISION MADE: 24-JUN-99
(OFF 8 MILES JALAN SKUDAI) 510(k) STATEMENT
SKUDAI, JOHOR BAHRU, JOHOR, MALAYSIA 81300
DEVICE: LATEX EXAMINATION GLOVES (PRE POWDERED)
USG HEALTHGUARD SDN BHD 510(k) NO: K991690(TRADITIONAL)
ATTN: TOH CHEE YEONG PHONE NO : 603 635 3882
LOT 2756 JALAN KEMPAS LAMA SE DECISION MADE: 24-JUN-99
(OFF 8 MILES JALAN SKUDAI) 510(k) STATEMENT
SKUDAI, JOHOR BAHRU, JOHOR, MALAYSIA 81300
DEVICE: RPM RESPIRATORY GATING SYSTEM
VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K983629(TRADITIONAL)
ATTN: LINDA S NASH PHONE NO : 650-424-6990
3045 HANOVER STREET SE DECISION MADE: 08-JUN-99
M/S H055 510(k) SUMMARY AVAILABLE FROM FDA
PALO ALTO, CA 94304-1129
DEVICE: EXPLOR-X 70
VILLA SISTEMI MEDICALI S.P.A. 510(k) NO: K991310(TRADITIONAL)
ATTN: AL SOSA PHONE NO : 847-459-3889
219 MAYER AVE. SE DECISION MADE: 18-JUN-99
WHEELING, IL 60090 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISTAKON (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR
VISTAKON, JOHNSON & JOHNSON VISION510(k) NO: K991163(TRADITIONAL)
ATTN: MARTINE D MARTINO PHONE NO : 904-443-1808
4500 SALISBURY ROAD SE DECISION MADE: 08-JUN-99
SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA
JACKSONVILLE, FL 32216
DEVICE: VITAL PEP
VITAL SIGNS, INC. 510(k) NO: K984468(TRADITIONAL)
ATTN: ANTHONY P MARTINO PHONE NO : 973-790-1330
20 CAMPUS RD. SE DECISION MADE: 01-JUN-99
TOTOWA, NJ 07512 510(k) STATEMENT
DEVICE: SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE
W & H DENTALWERK BUERMOOS GMBH 510(k) NO: K984508(TRADITIONAL)
ATTN: HERBERT TRASCHWANDTNER PHONE NO : 011 43 6274/62360
53 IGNAZ-GLASER-STRASSE SE DECISION MADE: 25-JUN-99
A-5111 510(k) STATEMENT
BUERMOOS, AUSTRIA 5111
DEVICE: GENTLE TOUCH UV (NETRAFILCON A) SOFT CONTACT LENSES
WESLEY JESSEN CORP. 510(k) NO: K991000(TRADITIONAL)
ATTN: JOSEPH FOOS PHONE NO : 847-294-3306
333 E. HOWARD AVENUE SE DECISION MADE: 28-JUN-99
DES PLAINES, IL 60018-5903 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: W-55 (METHAFILCON A) CLEAR AND VISIBILITY TINTED LENS BLANK AND
WESTCON CONTACT LENS CO., INC. 510(k) NO: K992010(SPECIAL)
ATTN: CAROL NOBLE PHONE NO : 970-245-3845
611 EISENHAUER ST. SE DECISION MADE: 29-JUN-99
GRAND JUNCTION, CO 81505 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUJI CATHETER, MODEL CTH001
WINDY HILL TECHNOLOGY, INC. 510(k) NO: K983867(TRADITIONAL)
ATTN: ANGELA B SOITO PHONE NO : 650-566-2330
1010 HAMILTON COURT SE DECISION MADE: 09-JUN-99
MENLO COURT, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITOP DRESSING
WONDER & BIOENERGY HI-TECH AMERICA510(k) NO: K990974(TRADITIONAL)
ATTN: ARTHUR KING K MA PHONE NO : 626-573-9220
108 N. YNEZ AVENUE, SUITE 128 SE DECISION MADE: 09-JUN-99
MONTEREY PARK, CA 91754 510(k) STATEMENT
DEVICE: PERFECTA RS LATERALIZED HIP STEM, BRIDGE HIP SYSTEM
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K991123(ABBREVIATED)
ATTN: LYNNE WITKOWSKI PHONE NO : 901-867-4620
5677 AIRLINE RD. SE DECISION MADE: 01-JUN-99
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NON-STERILE, POWDER FREE, POLYMER COATED LATEX EXAMINATION GLOVE
YTY INDUSTRY (MANJUNG) SDN. BHD. 510(k) NO: K991742(TRADITIONAL)
ATTN: E. J. SMITH PHONE NO : 410-451-0639
PO BOX 4341 SE DECISION MADE: 21-JUN-99
CROFTON, MD 21114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Z KAT FLUROTACTIC GUIDANCE SYSTEM MKI
Z-KAT, INC. 510(k) NO: K984298(TRADITIONAL)
ATTN: RONY ABOVITZ PHONE NO : 305-895-9022
11645 BISCAYNE BLVD SE DECISION MADE: 23-JUN-99
SUITE 304 510(k) SUMMARY AVAILABLE FROM FDA
MIAMI, FL 33181
DEVICE: ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM
ZEUS SCIENTIFIC, INC. 510(k) NO: K991179(TRADITIONAL)
ATTN: MARK J KOPNITSKY PHONE NO : 908-526-3744
200 EVANS WAY SE DECISION MADE: 17-JUN-99
BRANCHBURG, NJ 08876 510(k) STATEMENT
DEVICE: ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM.
ZEUS SCIENTIFIC, INC. 510(k) NO: K991610(TRADITIONAL)
ATTN: MARK J KOPNITSKY PHONE NO : 908-526-3744
200 EVANS WAY SE DECISION MADE: 25-JUN-99
BRANCHBURG, NJ 08876 510(k) STATEMENT
TOTAL 510(k)s THIS PERIOD 326
TOTAL WITH SUMMARIES 227
TOTAL WITH STATEMENTS 99
Updated 7/29/1999
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