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510(k)s Final Decisions Rendered for April 2004 |
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SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE)
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD 01-APR-2004 THROUGH 30-APR-2004
DEVICE: DYNATRAC, COD. 50-1A
3D LINE USA, INC. 510(k) NO: K034051(TRADITIONAL)
ATTN: NADER SALEHI PHONE NO : 703-467-8420
12100 SUNSET HILLS ROAD SE DECISION MADE: 05-APR-04
SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA
RESTON, VA 20190
DEVICE: XPERT BILIARY STENT, MODELS EX8L6006, EX8L3008, EX8L4008, EX8L60
ABBOT LABORATORIES 510(k) NO: K040667(SPECIAL)
ATTN: JOANNA KUSKOWSKI PHONE NO : 650-474-3331
400 SAGINAW DR. SE DECISION MADE: 07-APR-04
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYST
ABBOTT LABORATORIES 510(k) NO: K040814(SPECIAL)
ATTN: TRACEY H WIELINSKI PHONE NO : 781-276-6015
4-A CROSBY DR. SE DECISION MADE: 15-APR-04
BEDFORD, MA 01730-1402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AXSYM CYCLOSPORINE
ABBOTT LABORATORIES INC 510(k) NO: K040761(TRADITIONAL)
ATTN: GRACE LEMIEUX PHONE NO : 847-937-0165
100 ABBOTT PARK ROAD SE DECISION MADE: 30-APR-04
ABBOTT PARK, IL 60064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA
ACCU-STAT DIAGNOSTICS, INC. 510(k) NO: K040327(TRADITIONAL)
ATTN: JAMES G BARRONS PHONE NO : 949-916-7560
11 ORCHARD RD., SUITE 108 SE DECISION MADE: 19-APR-04
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACELL UBM SURGICAL MESH
ACELL, INC 510(k) NO: K040621(ABBREVIATED)
ATTN: PATSY J TRISLER PHONE NO : 301-652-5344
5610 WISCONSIN AVE SE DECISION MADE: 14-APR-04
#304 510(k) SUMMARY AVAILABLE FROM FDA
CHEVY CHASE, MD 20815
DEVICE: LIFESTYLE CIRCULATORY ENHANCER
ADVANCED CIRCULATORY SYSTEMS, INC.510(k) NO: K040084(ABBREVIATED)
ATTN: GARY SYRING PHONE NO : 608-877-2635
800 LEVANGER LANE SE DECISION MADE: 07-APR-04
STOUGHTON, WI 53589 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ART ANTERIOR SPINAL SYSTEM
ADVANCED MEDICAL TECHNOLOGIES AG 510(k) NO: K033148(TRADITIONAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD. SE DECISION MADE: 12-APR-04
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO STERRAD SEALSURE CHEMICAL INDICATOR TAPE
ADVANCED STERILIZATION PRODUCTS 510(k) NO: K040742(SPECIAL)
ATTN: KEVIN CORRIGAN PHONE NO : 949-453-6410
33 TECHNOLOGY DR. SE DECISION MADE: 02-APR-04
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROTOS SOFTWARE
AKTINA MEDICAL PHYSICS CORP. 510(k) NO: K040709(TRADITIONAL)
ATTN: TONY SPACCAROTELLA PHONE NO : 845-268-0101
360 NORTH ROUTE 9W SE DECISION MADE: 28-APR-04
CONGERS, NY 10920 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMS APOGEE VAULT SUSPENSION SYSTEM
AMERICAN MEDICAL SYSTEMS, INC. 510(k) NO: K040537(TRADITIONAL)
ATTN: ELSA A LINKE PHONE NO : 952-930-6000
10700 BREN RD., WEST SE DECISION MADE: 22-APR-04
MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANGIODYNAMICS, INC. MORE-FLOW HEMODIALYSIS CATHETER AND PROCEDUR
ANGIODYNAMICS, INC. 510(k) NO: K040402(TRADITIONAL)
ATTN: TERI JUCKETT PHONE NO : 518-798-1215
603 QUEENSBURY AVE. SE DECISION MADE: 19-APR-04
QUEENSBURY, NY 12804 510(k) STATEMENT
DEVICE: APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2
APOZA ENTERPRISE CO. LTD. 510(k) NO: K033198(TRADITIONAL)
ATTN: SHIH MIN-TEH PHONE NO : 886 229 010620
6 F,NO.657, CHUANG CHENG ROAD SE DECISION MADE: 30-APR-04
HSIN-CHUANG CITY 510(k) SUMMARY AVAILABLE FROM FDA
TAIPEI HSIEN, CHINA (TAIWAN) 242
DEVICE: NASOGASTRIC BRIDLE SYSTEM WITH MAGNETIC RETRIEVAL
APPLIED MEDICAL TECHNOLOGY, INC. 510(k) NO: K030784(TRADITIONAL)
ATTN: CHRIS ZANTOPULOS PHONE NO : 216-475-5577
15653 NEO PKWY. SE DECISION MADE: 01-APR-04
CLEVELAND, OH 44128 510(k) STATEMENT
DEVICE: UNIPORT SELF-CONTAINED PORTABLE DENTAL UNIT
ARROW INDUSTRIES LLC 510(k) NO: K040117(TRADITIONAL)
ATTN: ROBERT SYMINGTON PHONE NO : 701-886-7722
530 5TH STREET SE DECISION MADE: 21-APR-04
NECHE, ND 58265-4033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMOSONIC 200HEMODYNAMIC MONITOR
ARROW INTL., INC. 510(k) NO: K040802(SPECIAL)
ATTN: WILLIAM G MCLAIN PHONE NO : 610-378-0131
2400 BERNVILLE RD. SE DECISION MADE: 28-APR-04
READING, PA 19605 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVITA BPM6 SERIES BLOOD PRESSURE METER (OR MONITOR), MODEL BPM6X
AVITA CORPORATION 510(k) NO: K033397(TRADITIONAL)
ATTN: GEO LIN PHONE NO : 001 886 285121568
9F, NO. 78, SEC. 1, SE DECISION MADE: 09-APR-04
KWANG-FU RD. 510(k) SUMMARY AVAILABLE FROM FDA
SAN-CHUNG, TAIPEI COUNTY, CHINA (TAIWAN) 241
DEVICE: MFCD 2320
BARCO NV 510(k) NO: K040158(TRADITIONAL)
ATTN: FRANK FERGUSON PHONE NO : 505-332-8445
12200 ACADEMY ROAD NE, # 931 SE DECISION MADE: 12-APR-04
ALBUQUERQUE, NM 87111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLOR CORONIS 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM
BARCO NV 510(k) NO: K040365(TRADITIONAL)
ATTN: FRANK FERGUSON PHONE NO : 505-332-8445
12200 ACADEMY ROAD NE, # 931 SE DECISION MADE: 28-APR-04
ALBUQUERQUE, NM 87111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MFGD 2320 20 INCH 2 MEGAPIXEL GREYSCALE LCD DISPLAY
BARCO NV BARCOVIEW 510(k) NO: K033004(TRADITIONAL)
ATTN: FRANK FERGUSON PHONE NO : 505-332-8445
12200 ACADEMY ROAD NE SE DECISION MADE: 16-APR-04
# 931 510(k) SUMMARY AVAILABLE FROM FDA
ALBUQUERQUE, NM 87111
DEVICE: MFGD 1318 18 INCH 1 MEGAPIXEL GREYSCALE LCD DISPLAY
BARCO NV BARCOVIEW 510(k) NO: K033005(TRADITIONAL)
ATTN: FRANK FERGUSON PHONE NO : 505-332-8445
12200 ACADEMY ROAD NE SE DECISION MADE: 19-APR-04
# 931 510(k) SUMMARY AVAILABLE FROM FDA
ALBUQUERQUE, NM 87111
DEVICE: MIVD 1218 18 INCH GREYSCALE LCD DISPLAY MODULE
BARCO NV BARCOVIEW 510(k) NO: K033006(TRADITIONAL)
ATTN: FRANK FERGUSON PHONE NO : 505-332-8445
12200 ACADEMY ROAD NE SE DECISION MADE: 20-APR-04
# 931 510(k) SUMMARY AVAILABLE FROM FDA
ALBUQUERQUE, NM 87111
DEVICE: MGD 2621L MEDICAL GREYSCALE DISPLAY
BARCO NV BARCOVIEW 510(k) NO: K033103(TRADITIONAL)
ATTN: FRANK FERGUSON PHONE NO : 505-332-8445
12200 ACADEMY ROAD NE SE DECISION MADE: 16-APR-04
# 931 510(k) SUMMARY AVAILABLE FROM FDA
ALBUQUERQUE, NM 87111
DEVICE: MGD 2621P MEDICAL GREYSCALE DISPLAY
BARCO NV BARCOVIEW 510(k) NO: K033104(TRADITIONAL)
ATTN: FRANK FERGUSON PHONE NO : 505-332-8445
12200 ACADEMY ROAD NE SE DECISION MADE: 19-APR-04
# 931 510(k) SUMMARY AVAILABLE FROM FDA
ALBUQUERQUE, NM 87111
DEVICE: BRACHYTHERAPY STRAND DEVICE
BEBIG ISOTOPEN-UND MEDIZINTECHNIK 510(k) NO: K040339(TRADITIONAL)
ATTN: SVEN LANGER PHONE NO : 49 30 941084176
ROBERT-ROSSLE/STR.10 SE DECISION MADE: 08-APR-04
BERLIN, GERMANY 13125 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- CEFUROXIME GRAM NEGATI
BECTON DICKINSON & CO. 510(k) NO: K033362(TRADITIONAL)
ATTN: MICHELLE B BANDY PHONE NO : 410-316-4778
7 LOVETON CIR. SE DECISION MADE: 09-APR-04
SPARKS, MD 21152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TRIMETHOPRIM-SULFAMET
BECTON, DICKINSON & CO. 510(k) NO: K033907(TRADITIONAL)
ATTN: KATHRYN BABKA POWERS PHONE NO : 410-316-4260
7 LOVETON CIR. SE DECISION MADE: 09-APR-04
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROTAB ECG TABB ELECTRODE
BIO PROTECH, INC. 510(k) NO: K040784(TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 410-451-0639
P.O. BOX 4341 SE DECISION MADE: 07-APR-04
CROFTON, MD 21114 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BIO-DETEK ELECTRODE ADAPTER, MODEL R2001-90
BIO-DETEK, INC. 510(k) NO: K040056(TRADITIONAL)
ATTN: ROBERT MORSE PHONE NO : 800-225-1310
525 NARRAGANSETT PARK DR. SE DECISION MADE: 09-APR-04
PAWTUCKET, RI 02861-4323 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PEDI-PADZ RADIOLUCENT MULTI-FUNCTION PEDIATRIC ELECTRODES, MODEL
BIO-DETEK, INC. 510(k) NO: K040256(TRADITIONAL)
ATTN: ROBERT MORSE PHONE NO : 800-225-1310
525 NARRAGANSETT PARK DR. SE DECISION MADE: 09-APR-04
PAWTUCKET, RI 02861-4323 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BMR NEUROTECH BACK TENS AND LUMBAR SUPPORT DEVICE. TYPE 294
BIO-MEDICAL RESEARCH, LTD. 510(k) NO: K023916(TRADITIONAL)
ATTN: MICHELLE SAWYER PHONE NO : 353 917 74361
PARKMORE BUSINESS PARK, SE DECISION MADE: 15-APR-04
WEST GALWAY, IRELAND 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VARIANT II HEMOGLOBIN A1C
BIO-RAD LABORATORIES, INC. 510(k) NO: K040872(TRADITIONAL)
ATTN: JACKIE BUCKLEY PHONE NO : 510-741-5309
4000 ALFRED NOBEL DR. SE DECISION MADE: 15-APR-04
HERCULES, CA 94547 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: INTERFERENTIAL STIMULATOR, MODEL BMLS03-6
BIOMEDICAL LIFE SYSTEMS, INC. 510(k) NO: K040824(TRADITIONAL)
ATTN: GARY BUSSETT PHONE NO : 760-727-5600
P.O. BOX 1360 SE DECISION MADE: 29-APR-04
VISTA, CA 92085-1360 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VANGUARD PATELLA COMPONENTS
BIOMET MANUFACTURING, INC. 510(k) NO: K040770(SPECIAL)
ATTN: PATRICIA SANDBORN BERES PHONE NO : 574-267-6639
56 EAST BELL DR. SE DECISION MADE: 22-APR-04
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: CALCIGEN -NAP BONE VOID FILLER
BIOMET, INC. 510(k) NO: K033611(TRADITIONAL)
ATTN: MARY L VERSTYNEN PHONE NO : 574-267-6639
P.O. BOX 587 SE DECISION MADE: 27-APR-04
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IM TOTAL FEMUR
BIOMET, INC. 510(k) NO: K033871(TRADITIONAL)
ATTN: PATRICIA SANDBORN BERES PHONE NO : 574-267-6639
56 EAST BELL DR. SE DECISION MADE: 16-APR-04
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PELVIS BELLYBOARD PLUS PATIENT POSITIONING SYSTEM
BIONIX DEVELOPMENT CORP. 510(k) NO: K040773(TRADITIONAL)
ATTN: JAMES HUTTNER PHONE NO : 419-727-8421
5154 ENTERPRISE BLVD. SE DECISION MADE: 09-APR-04
TOLEDO, OH 43612 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: NOVA-ONE LIPID CONTROL (SPECIAL LOW INTERFERENCE LIQUID LIPID CO
BIORESOURCE TECHNOLOGY, INC. 510(k) NO: K040352(TRADITIONAL)
ATTN: ALAN POSNER PHONE NO : 954-792-5222
1531 N.W. 65TH AVE. SE DECISION MADE: 02-APR-04
FORT LAUDERDALE, FL 33313-4542 510(k) STATEMENT
DEVICE: BIOVALVE MINIJECT NEEDLE-FREE INJECTION SYSTEM, MODEL FG-01-001
BIOVALVE TECHNOLOGIES, INC. 510(k) NO: K032976(TRADITIONAL)
ATTN: SCOTT HUIE PHONE NO : 508-421-9500
ONE INNOVATION DR. SE DECISION MADE: 16-APR-04
3 BIOTECH 510(k) SUMMARY AVAILABLE FROM FDA
WORCESTER, MA 01605
DEVICE: BIRDSONG LEVERHALER, MODEL LH-1000
BIRDSONG MEDICAL DEVICES INC 510(k) NO: K031982(TRADITIONAL)
ATTN: ERIC FUGELSANG PHONE NO : 845-940-1570
1456 RT 22 SE DECISION MADE: 02-APR-04
BREWSTER, NY 10509 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESOLUTION HEMOSTASIS CLIPPING DEVICE
BOSTON SCIENTIFIC CORP. 510(k) NO: K040148(TRADITIONAL)
ATTN: JAMES D MCMAHON PHONE NO : 508-652-5566
ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 22-APR-04
NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERLOCKING DETACHABLE COIL SYSTEM (IDC)
BOSTON SCIENTIFIC CORP. 510(k) NO: K040342(TRADITIONAL)
ATTN: ARTHUR FRIEDMAN PHONE NO : 508-652-5082
ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 13-APR-04
NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATLANTIS SR, MODEL C4020; ATLANTIS SR PLUS, MODEL 35975
BOSTON SCIENTIFIC CORP. 510(k) NO: K040776(SPECIAL)
ATTN: ROBERT Z PHILLIPS PHONE NO : 510-624-2307
47900 BAYSIDE PARKWAY SE DECISION MADE: 29-APR-04
FREMONT, CA 94538-6515 510(k) STATEMENT
DEVICE: CONCERTO BIPOLAR NEEDLE ELECTRODE
BOSTON SCIENTIFIC CORP. 510(k) NO: K040785(SPECIAL)
ATTN: NICHOLAS CONDAKES PHONE NO : 508-652-5003
ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 28-APR-04
NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SURGICAL MESH POLYMERIC
BOSTON SCIENTIFIC CORP. 510(k) NO: K040787(SPECIAL)
ATTN: JANET A MCGRATH PHONE NO : 508-650-8726
ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 14-APR-04
NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERIVAC KIT, MODELS 4304, 4305, 4314, 4315
BOSTON SCIENTIFIC CORP. 510(k) NO: K040867(SPECIAL)
ATTN: RONALD C ALLEN PHONE NO : 408-895-3670
2710 ORCHARD PKWY. SE DECISION MADE: 30-APR-04
SAN JOSE, CA 95134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRANEMARK INTEGRATION DENTAL IMPLANT AND ACCESSORIES
BRANEMARK INTEGRATION AB 510(k) NO: K040643(SPECIAL)
ATTN: JAN-OLOF DJERF PHONE NO : 46 31 7601060
LILLA BOMMEN 1 SE DECISION MADE: 07-APR-04
GOTBORG, SWEDEN SE-411 04 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRITESMILE MASKING CREAM
BRITESMILE, INC. 510(k) NO: K040797(SPECIAL)
ATTN: SHEILA HEMEON-HEYER PHONE NO : 508-643-0434
49 PLAIN ST. SE DECISION MADE: 02-APR-04
NORTH ATTLEBORO, MA 02760 510(k) STATEMENT
DEVICE: PROTEGRITY STEILE LATEX SURGICAL GLOVES WITH COATING
CARDINAL HEALTH 510(k) NO: K033905(TRADITIONAL)
ATTN: ERICA SETHI PHONE NO : 847-785-3337
1500 WAUKEGAN RD. BLDG. WM SE DECISION MADE: 27-APR-04
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORTACLAMP
CARDIO LIFE RESEARCH, S.A. 510(k) NO: K033085(TRADITIONAL)
ATTN: JAMES R VEALE PHONE NO : 719-495-3438
49 PLAIN STREET SE DECISION MADE: 27-APR-04
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRATUSOCT WITH RNFL & MACULA NORMATIVE DATABASE
CARL ZEISS MEDITEC INC 510(k) NO: K033123(ABBREVIATED)
ATTN: R. MICHAEL CROMPTON PHONE NO : 925-557-4353
5160 HACIENDA DR. SE DECISION MADE: 20-APR-04
DUBLIN, CA 94568 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEDARA I-SOFTVIEW AND CEDARA I-READMAMMO
CEDARA SOFTWARE CORP. 510(k) NO: K040468(SPECIAL)
ATTN: CAROL NAKAGAWA PHONE NO : 905 672 2100
6509 AIRPORT RD. SE DECISION MADE: 23-APR-04
MISSISSAUGA, ONTARIO, CANADA L4V 1510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VECTRA TRANSPORTABLE COMBO AND STIM (SPECIALTY LINE DEALERS); IN
CHATTANOOGA GROUP 510(k) NO: K040285(TRADITIONAL)
ATTN: MICK DAVIS PHONE NO : 423-870-7209
4717 ADAMS RD. SE DECISION MADE: 12-APR-04
HIXSON, TN 37343 510(k) STATEMENT
DEVICE: AQUADEX SYSTEM 100, MODEL A1100
CHF SOLUTIONS, INC. 510(k) NO: K040489(SPECIAL)
ATTN: AMY PETERSON PHONE NO : 763-463-4620
SUITE 170-7601 NORTHLAND DR. SE DECISION MADE: 27-APR-04
BROOKLYN PARK, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFANT INCUBATOR, MODEL CHS-I1000
CHOONGWAE MEDICAL CORP. 510(k) NO: K040910(TRADITIONAL)
ATTN: RONALD D ARKIN PHONE NO : 770-565-6166
1733 CANTON LANE SE DECISION MADE: 21-APR-04
MARIETTA, GA 30062 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CHRONO-LOG WHOLE BLOOD AGGREGOMETER, MODELS 591A AND 592A
CHRONO-LOG CORP. 510(k) NO: K032951(TRADITIONAL)
ATTN: NICHOLAS J VERIABO PHONE NO : 610-853-1130
2 WEST PARK RD. SE DECISION MADE: 02-APR-04
HAVERTOWN, PA 19083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COALESCENT SURGICAL U-CLIP AND ACCESSORIES
COALESCENT SURGICAL 510(k) NO: K040821(TRADITIONAL)
ATTN: MICHAEL A DANIEL PHONE NO : 415-407-0223
559 EAST WEDDELL DR. SE DECISION MADE: 23-APR-04
SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPUMEDICS SUMMIT IP
COMPUMEDICS USA, LTD. 510(k) NO: K040194(TRADITIONAL)
ATTN: ELVIRA GARCIA PHONE NO : 915-225-0303
7850 PASEO DEL NORTE SE DECISION MADE: 23-APR-04
EL PASO, TX 79912 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONVATEC FECAL MANAGEMENT SYSTEM
CONVATEC, A BRISTOL-MYERS SQUIBB C510(k) NO: K032734(TRADITIONAL)
ATTN: NANCY REGULSKI PHONE NO : 908-904-2721
200 HEADQUARTERS PARK DR. SE DECISION MADE: 08-APR-04
SKILLMAN, NJ 08558 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COOK URETERAL BALLOON DILATION CATHETER SET
COOK UROLOGICAL, INC. 510(k) NO: K040127(TRADITIONAL)
ATTN: DEBBIE SCHMITT PHONE NO : 812-829-4891
1100 WEST MORGAN ST. SE DECISION MADE: 06-APR-04
SPENCER, IN 47460 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
COOK, INC. 510(k) NO: K033875(TRADITIONAL)
ATTN: KAREN BRADBURN PHONE NO : 812-339-2235
750 DANIELS WAY PO BX 489 SE DECISION MADE: 02-APR-04
BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826
CORGENIX, INC. 510(k) NO: K032139(TRADITIONAL)
ATTN: NANCI DEXTER PHONE NO : 303-457-4345
12061 TEJON ST. SE DECISION MADE: 05-APR-04
WESTMINSTER, CO 80234 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGIFROST 10 CM CRYOSURGICAL DEVICE PLUS FROSTBYTE CLAMP AND CR
CRYOCATH TECHNOLOGIES, INC. 510(k) NO: K040690(SPECIAL)
ATTN: FLOR DEL PILAR ARANA PHONE NO : 514 694 1212
16771 CHEMIN STE. MARIE SE DECISION MADE: 29-APR-04
KIRKLAND, QUEBEC, CANADA H9H 5H3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RECLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0012
CURELIGHT LTD 510(k) NO: K033183(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, N.W. SE DECISION MADE: 15-APR-04
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTLITE D FREQUENCY DOUBLED ND:YAG LASER
CYNOSURE, INC. 510(k) NO: K040289(TRADITIONAL)
ATTN: GEORGE CHO PHONE NO : 978-256-2400
10 ELIZABETH DR. SE DECISION MADE: 30-APR-04
CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANEL WITH CEPHAL
DADE BEHRING, INC. 510(k) NO: K031601(TRADITIONAL)
ATTN: ROBERT EUSEBIO PHONE NO : 916-374-3183
2040 ENTERPRISE BLVD. SE DECISION MADE: 02-APR-04
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: URINE AMPHETAMINE/METHAMPHETAMINE SCREEN FLEX REAGENT CARTRIDGE
DADE BEHRING, INC. 510(k) NO: K040133(TRADITIONAL)
ATTN: ANDREA M TASKER PHONE NO : 302-631-9454
GLASGOW BUSINESS COMMUNITY; SE DECISION MADE: 08-APR-04
BLDG. 500 P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: MODIFICATION TO DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM
DATEX-OHMEDA, INC. 510(k) NO: K040743(SPECIAL)
ATTN: DAN KOSEDNAR PHONE NO : 608-221-1551
P.O. BOX 7550 SE DECISION MADE: 22-APR-04
MADISON, WI 53707 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLYLASE LP
DDC TECHNOLOGIES, INC. 510(k) NO: K040055(TRADITIONAL)
ATTN: DMITRY DONSKOY PHONE NO : 516-770-0441
2980 WAVERLY AVE. SE DECISION MADE: 07-APR-04
OCEANSIDE, NY 11572 510(k) STATEMENT
DEVICE: HRV TOOLS
DEL MAR REYNOLDS MEDICAL, LTD. 510(k) NO: K040313(TRADITIONAL)
ATTN: GEORGE MYERS PHONE NO : 201-727-1703
377 ROUTE 17 S SE DECISION MADE: 06-APR-04
HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOFREE
DENTAL COMPONENTS, INC. 510(k) NO: K033925(TRADITIONAL)
ATTN: RICHARD W HANSON PHONE NO : 503-538-8343
305 NORTH SPRINGBROOK RD. SE DECISION MADE: 07-APR-04
P.O. BOX 228 510(k) STATEMENT
NEWBERG, OR 97132-0228
DEVICE: QUIXX POSTERIOR RESTORATIVE
DENTSPLY INTERNATIONAL 510(k) NO: K040144(TRADITIONAL)
ATTN: P JEFFERY LEHN PHONE NO : 717-845-7511
221 WEST PHILADELPHIA ST. SE DECISION MADE: 01-APR-04
SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17404
DEVICE: IDEAL 1 ORTHODONTIC BAND CEMENT
DENTSPLY INTL. 510(k) NO: K040375(TRADITIONAL)
ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511
221 WEST PHILADELPHIA STREET SE DECISION MADE: 02-APR-04
SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17404
DEVICE: EAGLE ANTERIOR CERVIAL PLATE SYSTEM
DEPUY ACROMED 510(k) NO: K040197(SPECIAL)
ATTN: LISA GILMAN PHONE NO : 508-880-8287
325 PARAMOUNT DR. SE DECISION MADE: 02-APR-04
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHOCORD SUTURE
DEPUY MITEK 510(k) NO: K040004(TRADITIONAL)
ATTN: RUTH C FORSTADT PHONE NO : 781-251-3188
249 VANDERBILT DR. SE DECISION MADE: 13-APR-04
NORWOOD, MA 02062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PANALOK LOOP ANCHOR
DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K040827(SPECIAL)
ATTN: ALLYSON BARFORD PHONE NO : 781-251-2794
249 VANDERBILT DR. SE DECISION MADE: 30-APR-04
NORWOOD, MA 02062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO DEPUY CERAMIC FEMORAL HEAD
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K040644(SPECIAL)
ATTN: REBECCA L LENNARD PHONE NO : 574-372-5023
700 ORTHOPAEDIC DR. SE DECISION MADE: 08-APR-04
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: TRUST
DHD HEALTHCARE CORP. 510(k) NO: K040718(TRADITIONAL)
ATTN: DAVID GEARY PHONE NO : 315-363-2330
ONE MADISON ST. SE DECISION MADE: 02-APR-04
WAMPSVILLE, NY 13163 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BICARD MIXING SYSTEM
DIALYSIS SYSTEMS, INC. 510(k) NO: K030366(TRADITIONAL)
ATTN: MARK VESLIGAJ PHONE NO : 615-292-0333
2003 BLAIR BLVD. SE DECISION MADE: 19-APR-04
NASHVILLE, TN 37212 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIPTER X-1 COMPACT
DIREX SYSTEMS CORP. 510(k) NO: K040470(SPECIAL)
ATTN: LARISA GERSHTEIN PHONE NO : 508-651-0900
11 MERCER RD. SE DECISION MADE: 28-APR-04
NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ACCULEAF
DIREX SYSTEMS CORP. 510(k) NO: K040553(SPECIAL)
ATTN: LARISA GERSHTEIN PHONE NO : 508-651-0900
11 MERCER RD. SE DECISION MADE: 01-APR-04
BUSINESS PARK 510(k) SUMMARY AVAILABLE FROM FDA
NATICK, MA 01760
DEVICE: CUSTODIOL
DR. FRANZ KOHLER CHEMIE GMBH 510(k) NO: K032794(TRADITIONAL)
ATTN: T. WHIT ATHEY PHONE NO : 301-570-0013
2305 GOLD MINE RD. SE DECISION MADE: 05-APR-04
BROOKEVILLE, MD 20833 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFINITY GAMMAXL AND SC 6802XL WITH THE SCIO GAS MODULE
DRAEGER MEDICAL SYSTEMS, INC. 510(k) NO: K040188(TRADITIONAL)
ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500
16 ELECTRONICS AVE. SE DECISION MADE: 14-APR-04
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NARKOMED 6400, MODEL NM6400
DRAEGER MEDICAL, INC. 510(k) NO: K033498(TRADITIONAL)
ATTN: GALE E WINARSKY PHONE NO : 215-721-5400
3135 QUARRY RD. SE DECISION MADE: 26-APR-04
TELFORD, PA 18969 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HAWK INTRAORAL CAMERA AND ACCESSORIES
DXM CO., LTD. 510(k) NO: K040116(TRADITIONAL)
ATTN: CAROLANN KOTULA PHONE NO : 770-985-8203
55 NORTHERN BLVD. SE DECISION MADE: 20-APR-04
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: DYMEDIX REUSABLE RESPIRATORY EFFORT BELT SENSOR, MODEL 6015 AND
DYMEDIX, INC. 510(k) NO: K040605(ABBREVIATED)
ATTN: GARY SYRING PHONE NO : 608-877-2635
800 LEVANGER LN. SE DECISION MADE: 26-APR-04
STOUGHTON, WI 53589 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TROPHYPAN C WITH ORTHOIMAGING/OMSIMAGING ACCESSORY
EASTMAN KODAK COMPANY 510(k) NO: K040556(SPECIAL)
ATTN: DONALD ELLIS PHONE NO : 585-724-4064
343 STATE ST. SE DECISION MADE: 07-APR-04
ROCHESTER, NY 14650 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EASY MED TN-28 C
EASYMED INSTRUMENT CO., LTD. 510(k) NO: K040253(TRADITIONAL)
ATTN: WU TINGJIE PHONE NO : 86 765 772782
2/F-3/F, NO.2 BEIHAI DA ROAD SE DECISION MADE: 08-APR-04
LUNJIAO, SHUNDE 510(k) SUMMARY AVAILABLE FROM FDA
GUANGDONG, CHINA 528303 THIRD PARTY REVIEW
DEVICE: EBI ESL SPINE SPACER SYSTEM
EBI, L.P. 510(k) NO: K040482(TRADITIONAL)
ATTN: FREDERIC TESTA PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 16-APR-04
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM
EBI, L.P. 510(k) NO: K040833(SPECIAL)
ATTN: FREDERIC TESTA PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 29-APR-04
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/CONTINUOUS END DIAS
EDWARDS LIFESCIENCES, LLC. 510(k) NO: K040287(TRADITIONAL)
ATTN: PAULA A TORRIANNI PHONE NO : 949-250-2418
ONE EDWARDS WAY SE DECISION MADE: 26-APR-04
IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 2000EZ
ELECTROMED, INC. 510(k) NO: K040367(SPECIAL)
ATTN: CHET SIEVERT PHONE NO : 952-758-9299
502 SIXTH AVE. N.W. SE DECISION MADE: 07-APR-04
NEW PRAGUE, MN 56071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONO TT ULTRASONIC FLOWCOMPUTER
EM-TEC GMBH 510(k) NO: K040909(TRADITIONAL)
ATTN: ANDREAS KNABE PHONE NO : 49 088 0692360
LERCHENBERG 20 SE DECISION MADE: 20-APR-04
FINNING, GERMANY 86923 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: EP DEFLECTABLE CATHETERS
EP MEDSYSTEMS, INC. 510(k) NO: K033963(SPECIAL)
ATTN: JAMES E KUHN, JR. PHONE NO : 856-753-8533
COOPER RUN EXECUTIVE PARK SE DECISION MADE: 15-APR-04
575 ROUTE 73 NORTH, BUILDING D 510(k) STATEMENT
WEST BERLIN, NJ 08091-9293
DEVICE: ULTRAPRO MESH
ETHICON, INC. 510(k) NO: K033337(TRADITIONAL)
ATTN: REY LIBROJO PHONE NO : 908-218-3198
ROUTE 22 WEST SE DECISION MADE: 01-APR-04
SOMERVILLE, NJ 08876 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PARAMOUNT MINI GPS BILIARY STENT SYSTEM
EV3 INC 510(k) NO: K040653(SPECIAL)
ATTN: MARIA E BRITTLE PHONE NO : 763-398-7353
4600 NATHAN LN. NORTH SE DECISION MADE: 28-APR-04
PLYMOUTH, MN 55442-2920 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FELCARE POWDER FREE, POLYMER COATED LATEX EXAMINATION GLOVES
FELDA RUBBER PRODUCTS SDN BHD 510(k) NO: K040793(TRADITIONAL)
ATTN: KOK-KEE HON PHONE NO : 703-941-7656
6324 MEETINGHOUSE WAY SE DECISION MADE: 14-APR-04
ALEXANDRIA, VA 22312-1718 510(k) STATEMENT
DEVICE: DICOM THEATER
FERGUSON MEDICAL 510(k) NO: K033153(TRADITIONAL)
ATTN: FRANK FERGUSON PHONE NO : 505-332-8445
12200 ACADEMY ROAD NE SE DECISION MADE: 23-APR-04
#931 510(k) SUMMARY AVAILABLE FROM FDA
ALBUQUERQUE, NM 87111
DEVICE: FINE SURGICAL CIRCUMCISION CLAMP
FINE SURGICAL INSTRUMENT CORP. 510(k) NO: K040052(TRADITIONAL)
ATTN: CAROLANN KOTULA PHONE NO : 770-985-8203
55 NORTHERN BLVD. SE DECISION MADE: 09-APR-04
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MR850 RESPIRATORY HUMIDIFIER, MODEL MR850JHU
FISHER & PAYKEL HEALTHCARE, LTD. 510(k) NO: K033710(TRADITIONAL)
ATTN: BRETT WHISTON PHONE NO : 649 574 0100
P.O BOX 14-348 SE DECISION MADE: 13-APR-04
PANMURE, AUCKLAND, NEW ZEALAND 170510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: FREEDOM HP
FREEDOM DESIGNS, INC. 510(k) NO: K040622(TRADITIONAL)
ATTN: GINNY S MALOCO PHONE NO : 805-582-0077
2241 MADERA RD. SE DECISION MADE: 16-APR-04
SIMI VALLEY, CA 93065 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GC INITIAL MC, AL AND LF
GC AMERICA, INC. 510(k) NO: K040567(TRADITIONAL)
ATTN: TERRY L JORITZ PHONE NO : 708-926-3105
3737 WEST 127TH ST. SE DECISION MADE: 22-APR-04
ALSIP, IL 60803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO GE DISCOVERY LS SYSTEM
GE MEDICAL SYSTEMS 510(k) NO: K040172(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO :
P.O. BOX 414 SE DECISION MADE: 07-APR-04
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENOGRAPHIC STEREO
GE MEDICAL SYSTEMS, INC. 510(k) NO: K040125(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894
3000 N. GRANDVIEW BLVD. SE DECISION MADE: 19-APR-04
WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE SIGNA 3.0T WITH EXCITE MR SYSTEM
GENERAL ELECTRIC CO. 510(k) NO: K040444(SPECIAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894
P.O. BOX 414 SE DECISION MADE: 14-APR-04
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENZYME OSOM TRICHOMONAS RAPID TEST
GENZYME CORP. 510(k) NO: K033864(TRADITIONAL)
ATTN: E.V. GOORCHENKO PHONE NO : 858-777-2614
ONE KENDALL SQUARE SE DECISION MADE: 02-APR-04
CAMBRIDGE, MA 02139 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES - POWDER FRE
GRAND WORK PLASTIC PRODUCTS CO., L510(k) NO: K040702(TRADITIONAL)
ATTN: JAMES CHU PHONE NO : 714-990-6888
590 W. CENTRAL AVE., #D SE DECISION MADE: 27-APR-04
BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTI-RIDER DELUXE
HANSUNG ECONET CO., LTD. 510(k) NO: K033116(TRADITIONAL)
ATTN: CYNTHIA J.M. NOLTE PHONE NO : 919-859-4207
49 PLAIN STREET SE DECISION MADE: 12-APR-04
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TELECARE D.R. SERVER SOFTWARE SYSTEM
HEALTHCARE VISION, INC. 510(k) NO: K033133(TRADITIONAL)
ATTN: CRAIG WALKER PHONE NO : 817-531-8992
2601 SCOTT AVENUE SE DECISION MADE: 13-APR-04
SUITE 600 510(k) SUMMARY AVAILABLE FROM FDA
FORT WORTH, TX 76103
DEVICE: HITACHI PRESTO
HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K040902(ABBREVIATED)
ATTN: DOUGLAS THISTLETHWAITE PHONE NO : 330-425-1313
1959 SUMMIT COMMERCE PARK SE DECISION MADE: 21-APR-04
TWINSBURG, OH 44087-2371 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM
HOLOGIC, INC. 510(k) NO: K040884(SPECIAL)
ATTN: GAIL YAEKER-DAUNIS PHONE NO : 203-731-8337
36 APPLE RIDGE ROAD SE DECISION MADE: 23-APR-04
DANBURY, CT 06810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCORPIO TOTAL KNEE SYSTEM
HOWMEDICA OSTEONICS CORP 510(k) NO: K033972(TRADITIONAL)
ATTN: DENISE DUCHENE PHONE NO : 201-831-5612
325 CORPORATE DR. SE DECISION MADE: 12-APR-04
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DELIGHT DENTAL ER: YAG LASER SYSTEM
HOYA PHOTONICS, INC. 510(k) NO: K032797(TRADITIONAL)
ATTN: THOMAS HANEY PHONE NO : 800-532-1064
47733 FREMONT BLVD. SE DECISION MADE: 05-APR-04
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HTTP SYSTEM (HTTP 2001 CONTROLLER AND HTTP WARM ME BLANKETS)
HTTP HYPOTHERMIA THERAPY 510(k) NO: K040440(TRADITIONAL)
ATTN: DORITH BAR-ADON PHONE NO : 972 2 5879148
BEIT RAMPE HAR HOTZVIM, SE DECISION MADE: 27-APR-04
JERUSALEM, ISRAEL 91236 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TALON INFUSION SET, MODEL IP XXXX
ICU MEDICAL, INC. 510(k) NO: K033290(TRADITIONAL)
ATTN: DALE FAIRCHILD PHONE NO : 949-366-2183
951 CALLE AMANECER SE DECISION MADE: 12-APR-04
SAN CLEMENTE, CA 92673 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEOGEN SBRG
IMPLADENT, LTD. 510(k) NO: K033098(TRADITIONAL)
ATTN: MAURICE VALEN PHONE NO : 718-465-1810
198-45 FOOTHILL AVE. SE DECISION MADE: 27-APR-04
HOLLISWOOD, NY 11423 510(k) STATEMENT
DEVICE: LUCENTLITE, MODEL IMD 010
INDUSTRIAL & MEDICAL DESIGN, INC. 510(k) NO: K033072(TRADITIONAL)
ATTN: YEVGENIY KUKLIN PHONE NO : 323-981-8577
2570 CORPORATE PL., SUITE E104 SE DECISION MADE: 01-APR-04
MONTEREY PARK, CA 91754 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAFETYNET GUIDEWIRE INTRODUCER
INJECTIMED, INC. 510(k) NO: K040029(TRADITIONAL)
ATTN: GEORGE C BRDLIK PHONE NO : 760-390-3298
6442 MERLIN DRIVE SE DECISION MADE: 05-APR-04
CARLSBAD, CA 92009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYBRID ENDOPORE ENDOSSEOUS DENTAL IMPLANT
INNOVA CORP. 510(k) NO: K040714(SPECIAL)
ATTN: HOWARD HOLSTEIN PHONE NO : 202-637-5813
C/O HOGAN & HARTSON SE DECISION MADE: 09-APR-04
555 THIRTEENTH STREET, N.W. 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20004
DEVICE: INSTRUMED LAPAROSCOPE AND ACCESSORIES
INSTRUMED INTERNATIONAL, INC. 510(k) NO: K040855(TRADITIONAL)
ATTN: HAIKO BELL PHONE NO : 49 746 496600
KAISERSTR. 9 SE DECISION MADE: 16-APR-04
TUNINGEN, B.W., GERMANY 78609 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: HEMOSIL VON WILLEBRAND ACTIVITY
INSTRUMENTATION LABORATORY CO. 510(k) NO: K040843(TRADITIONAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
113 HARTWELL AVE. SE DECISION MADE: 30-APR-04
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LICOX PMO BRAIN MONITORING SYSTEM
INTEGRA LIFESCIENCES CORPORATION 510(k) NO: K040235(TRADITIONAL)
ATTN: NANCY MATHEWSON PHONE NO : 858-455-8298
311 ENTERPRISE DR. SE DECISION MADE: 20-APR-04
PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATRAMAT AND SORB-FAST POLYGLYCOLIC ACID
INTERNACIONAL FARMACEUTICA, S.A. D510(k) NO: K040282(TRADITIONAL)
ATTN: CAROLANN KOTULA PHONE NO : 770-985-8203
55 NORTHERN BLVD. SE DECISION MADE: 29-APR-04
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: ALTIUS OCT SYSTEM
INTERPORE CROSS INTL. 510(k) NO: K033961(SPECIAL)
ATTN: WENDY SPIELBERGER PHONE NO : 949-453-3200
181 TECHNOLOGY DR. SE DECISION MADE: 14-APR-04
IRVINE, CA 92618-2402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO GEO STRUCTURE
INTERPORE CROSS INTL. 510(k) NO: K040168(SPECIAL)
ATTN: WENDY SPIELBERGER PHONE NO : 949-453-3200
181 TECHNOLOGY DR. SE DECISION MADE: 08-APR-04
IRVINE, CA 92618-2402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPPRO ESP, MODELS ESP 603-18-05, ESP 603-18-09
INVAMED TECHNOLOGIES INC. 510(k) NO: K032981(TRADITIONAL)
ATTN: TIM DUVALL PHONE NO : 925-820-3128
9955 TITAN PARK CIRCLE SE DECISION MADE: 22-APR-04
LITTLETON, CO 80125 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTIBLAST MEDIUM
IRVINE SCIENTIFIC SALES CO., INC. 510(k) NO: K034063(TRADITIONAL)
ATTN: WENDELL LEE PHONE NO : 800-437-5706
2511 DAIMLER ST. SE DECISION MADE: 26-APR-04
SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISOAID ADVANTAGE PD-103, MODEL IAPD-103A
ISOAID, L.L.C. 510(k) NO: K033770(TRADITIONAL)
ATTN: MAX TAGHIZADEH PHONE NO : 727-815-2362
7824 CLARK MOODY BLVD. SE DECISION MADE: 08-APR-04
PORT RICHEY, FL 34668 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLUEWAND LED DENTAL CURING WAND SYSTEM
J.L. BLOSSER, INC. 510(k) NO: K040614(TRADITIONAL)
ATTN: LARRY L BLOSSER PHONE NO : 816-781-3206
22 NORTH MAIN SE DECISION MADE: 07-APR-04
LIBERTY, MO 64068 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOMAT LC PUMP, MODEL 20 3303 20
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K031457(TRADITIONAL)
ATTN: PAUL S LEE PHONE NO : 310-410-2769
600 CORPORATE POINTE SE DECISION MADE: 28-APR-04
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KATALYST RADIAL HEAD IMPLANT
KINETIKOS MEDICAL, INC. 510(k) NO: K032806(TRADITIONAL)
ATTN: JOHN G SPAMPINATO PHONE NO : 760-448-1706
6005 HIDDEN VALLEY RD, STE 180 SE DECISION MADE: 16-APR-04
CARLSBAD, CA 92009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 2
KING SYSTEMS CORP. 510(k) NO: K033186(SPECIAL)
ATTN: TOM MCGRAIL PHONE NO : 800-642-5464
15011 HERRIMAN BLVD. SE DECISION MADE: 14-APR-04
NOBLESVILLE, IN 46060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PIGGYBACK IRRIGATING SYSTEM
KOSIN TECHNOLOGIES, LLC 510(k) NO: K040094(ABBREVIATED)
ATTN: AVTAR S DHINDSA PHONE NO : 219-508-3419
3305 GREYFOX DRIVE SE DECISION MADE: 15-APR-04
VALPARAISO, IN 46383 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMOCLEAN
KRD CO., LTD 510(k) NO: K023064(TRADITIONAL)
ATTN: JEFFERY R SHIDEMAN PHONE NO : 952-835-4018
ANDERSON CONSULTING INTL. SE DECISION MADE: 06-APR-04
7307 GLOUCHESTER DRIVE 510(k) SUMMARY AVAILABLE FROM FDA
EDINA, MN 55435
DEVICE: KYPHX HV-R, MODEL C01A
KYPHON, INC. 510(k) NO: K033801(TRADITIONAL)
ATTN: CINDY DOMECUS PHONE NO : 408-548-6500
1350 BORDEAUX DR. SE DECISION MADE: 01-APR-04
SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LANX ANTERIOR CERVIAL PLATE SYSTEM
LANX, LLC 510(k) NO: K040401(TRADITIONAL)
ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640
200 GREGORY LANE SE DECISION MADE: 12-APR-04
SUITE C-100 510(k) SUMMARY AVAILABLE FROM FDA
PLEASANT HILL, CA 94523-3389
DEVICE: DOSI-FUSER
LEVENTON, S.A. 510(k) NO: K040752(TRADITIONAL)
ATTN: JOAQUIM SORIANO PHONE NO : 34 93 8176300
C/NEWTON 18-24 SE DECISION MADE: 07-APR-04
POLIGONO INDUSTRIAL SESROVIRES 510(k) SUMMARY AVAILABLE FROM FDA
SANT ESTEVE SESROVIRES, SPAIN 0863THIRD PARTY REVIEW
DEVICE: CAMP MULTIPLE ANALYTE ENZYME IMMUNOASSAY, CAT.# 0510, 0511 (500
LIN-ZHI INTERNATIONAL, INC. 510(k) NO: K033866(TRADITIONAL)
ATTN: CHENG-I LIN PHONE NO : 408-732-3856
687 NORTH PASTORIA AVE. SE DECISION MADE: 07-APR-04
SUNNYVALE, CA 94085-2917 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CANNULATED NUGEN FX SCREW FULLY THREADED, CANNULATED NUGEN FX SC
LINVATEC BIOMATERIALS, LTD. 510(k) NO: K032447(SPECIAL)
ATTN: TUIJA ANNALA PHONE NO : 888-462-8878
HERMIANKATU 6-8L SE DECISION MADE: 16-APR-04
TAMPERE, FINLAND 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO OUTBACK CATHETER
LUMEND, INC. 510(k) NO: K040771(SPECIAL)
ATTN: MICHAEL A DANIEL PHONE NO : 650-364-1400
400 CHESAPEAKE DR. SE DECISION MADE: 23-APR-04
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SERVO GUARD, MODEL 64 81 290 EH88E
MAQUET, INC. 510(k) NO: K030071(TRADITIONAL)
ATTN: JAMIE YIEH PHONE NO : 908-947-2311
1140 ROUTE 22 EAST SE DECISION MADE: 26-APR-04
SUITE 202 510(k) SUMMARY AVAILABLE FROM FDA
BRIDGEWATER, NJ 08807
DEVICE: MASIMO SET INTELLIVUE PULSE OXIMETER MODULE
MASIMO CORP. 510(k) NO: K040259(TRADITIONAL)
ATTN: JAMES J CRONIN PHONE NO : 949-250-9688
2852 KELVIN AVE. SE DECISION MADE: 22-APR-04
IRVINE, CA 92614-5826 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAYO CLINIC BC-10 3.0T
MAYO CLINIC 510(k) NO: K040122(SPECIAL)
ATTN: JADE SADOSTY PHONE NO : 507-538-1352
200 FIRST ST. SW SE DECISION MADE: 14-APR-04
ROCHESTER, MN 55905 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BP CUFF BARRIER 1081789, BP CUFF BARRIER, PLASTIC COATED 1030193
MED TEXTILE, LLC 510(k) NO: K032568(TRADITIONAL)
ATTN: BRITTNEY GILL PHONE NO : 877-772-8378
14300 WOOD DUCK LANE SE DECISION MADE: 29-APR-04
COLONIAL HEIGHTS, VA 23834 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP
MEDEX, INC. 510(k) NO: K040899(TRADITIONAL)
ATTN: BARBARA LAW PHONE NO : 614-791-5568
6250 SHIER RINGS RD. SE DECISION MADE: 30-APR-04
DUBLIN, OH 43016 510(k) STATEMENT
DEVICE: MEDI-STIM VERIQ SYSTEM, MODEL VQ1001 - VQ4122
MEDI-STIM A/S 510(k) NO: K040228(TRADITIONAL)
ATTN: JON H HOEM PHONE NO : 763-493-6664
7601 NORTHLAND DRIVE SE DECISION MADE: 29-APR-04
MAILSTOP A150 510(k) SUMMARY AVAILABLE FROM FDA
BROOKLYN PARK, MN 55428
DEVICE: MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVEL
MEDICAL ANALYSIS SYSTEMS, INC. 510(k) NO: K040880(TRADITIONAL)
ATTN: PENNY M LAYMAN PHONE NO : 805-987-7891
5300 ADOLFO RD. SE DECISION MADE: 28-APR-04
CAMARILLO, CA 93012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL GST-1
MEDICAL EQUIPMENT DEVICE SPECIALIS510(k) NO: K040193(TRADITIONAL)
ATTN: C.A. TEKLINSKI PHONE NO : 619-665-4912
9811 W. CHARLESTON #2387 SE DECISION MADE: 27-APR-04
LAS VEGAS, NV 89117 510(k) STATEMENT
DEVICE: PREVIEW TREATMENT PLANNING SOFTWARE
MEDICAL MEDIA SYSTEMS, INC. 510(k) NO: K040852(SPECIAL)
ATTN: PATSY J TRISLER PHONE NO : 301-652-5344
5610 WISCONSIN AVENUE # 304 SE DECISION MADE: 23-APR-04
CHEVY CHASE, MD 20815 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDISIL SILICONE SHEETING
MEDISIL CORPORATION 510(k) NO: K040042(TRADITIONAL)
ATTN: ALASTAIR WINN PHONE NO : 805-643-0211
1735 N. OLIVE STREET SE DECISION MADE: 01-APR-04
VENTURA, CA 93001 510(k) STATEMENT
DEVICE: MEDSAFE SYSTEM INSERTER
MEDSOLVE TECHNOLOGIES LLC 510(k) NO: K032848(TRADITIONAL)
ATTN: SUSAN MCCONNELL PHONE NO : 818-223-8537
4635 GERSHWIN PLACE SE DECISION MADE: 12-APR-04
WOODLAND HILLS, CA 91364 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MSI MODEL S-500 RF GENERATOR
MEDSPHERE INTERNATIONAL, INC 510(k) NO: K033888(TRADITIONAL)
ATTN: ERIC KAO PHONE NO : 510-656-8232
48511 WARM SPRINGS BLVD. SE DECISION MADE: 02-APR-04
SUITE 212 510(k) SUMMARY AVAILABLE FROM FDA
FREMONT, CA 94539
DEVICE: MEDTRONIC MINIMED MMT-407C AMBULATORY INFUSION PUMP, MODEL MMT-4
MEDTRONIC MINIMED 510(k) NO: K040061(TRADITIONAL)
ATTN: GERDA P RESCH PHONE NO : 818-362-5958
18000 DEVONSHIRE ST. SE DECISION MADE: 08-APR-04
NORTHRIDGE, CA 91325-1219 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFEPAK 12
MEDTRONIC PHYSIO-CONTROL CORP. 510(k) NO: K040775(SPECIAL)
ATTN: MICHELLE ACKERMANN PHONE NO : 425-867-4744
11811 WILLOWS RD NE SE DECISION MADE: 23-APR-04
P.O. BOX 97006 510(k) SUMMARY AVAILABLE FROM FDA
REDMOND, WA 98073-9706
DEVICE: MODIFICATION TO CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K034056(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 21-APR-04
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EASYTEM DUO, FOREHEAD/EAR THERMOMETER, MODEL BT-021
METATECH CO., LTD. 510(k) NO: K033077(TRADITIONAL)
ATTN: GUENTER GINSBERG PHONE NO : 941-948-2001
11820 RED HIBISCUS DR. SE DECISION MADE: 30-APR-04
BONITA SPRINGS, FL 34135 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITALSENSE
MINI-MITTER CO., INC. 510(k) NO: K033534(TRADITIONAL)
ATTN: JACK E MCKENZIE PHONE NO : 800-685-2999
20300 EMPIRE AVE. BLDG. B-3 SE DECISION MADE: 22-APR-04
BEND, OR 97701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RENACLEAN SH DIALYZER CLEANING SYSTEM
MINNTECH CORP. 510(k) NO: K033505(TRADITIONAL)
ATTN: RICHARD M ORMSBEE PHONE NO : 763-551-2689
14605 28TH AVE. NORTH SE DECISION MADE: 27-APR-04
MINNEAPOLIS, MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEM 3000 HEAD COIL
MR INSTRUMENTS, INC. 510(k) NO: K040937(TRADITIONAL)
ATTN: GENE BERGHOFF PHONE NO : 952-746-1435
4802 PARK GLEN RD. SE DECISION MADE: 23-APR-04
MINNEAPOLIS, MN 55416 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: LOVELY SYSTEM
MSQ (M2) LTD. 510(k) NO: K033946(TRADITIONAL)
ATTN: ANNE WORDEN PHONE NO : 925-426-8927
3637 BERNAL AVENUE SE DECISION MADE: 05-APR-04
PLEASANTON, CA 94566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAIMCO, INC., IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 201
NAIMCO, INC. 510(k) NO: K040495(TRADITIONAL)
ATTN: ROBERT L MCCLURE PHONE NO : 888-549-4945
4120 SOUTH CREEK ROAD SE DECISION MADE: 22-APR-04
CHATTANOOGA, TN 37406 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KETOCHECKS
NEO DIAGNOSTICS, INC 510(k) NO: K033114(TRADITIONAL)
ATTN: SUNG PYO PHONE NO : 714-226-0070
10532 WALKER ST. SE DECISION MADE: 26-APR-04
SUITE B 510(k) SUMMARY AVAILABLE FROM FDA
CYPRESS, CA 90630
DEVICE: VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATING
NEO METRICS, INC. 510(k) NO: K040786(SPECIAL)
ATTN: GENE CHAMPEAU PHONE NO : 763-559-4440
14800 28TH AVENUE NORTH SE DECISION MADE: 19-APR-04
SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA
PLYMOUTH, MN 55447
DEVICE: NMX-1000
NEOMEDIX CORP. 510(k) NO: K040584(TRADITIONAL)
ATTN: SOHEILA MIRHASHEMI PHONE NO : 949-248-7029
27452 CALLE ARROYO SE DECISION MADE: 22-APR-04
SAN JUAN CAPISTRANO, CA 92675-2748510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: COOLTOUCH; COOLTOUCH II; AND COOLTOUCH CT3 ND:YAG LASER SYSTEM
NEW STAR LASERS, INC. 510(k) NO: K040131(TRADITIONAL)
ATTN: DONALD V JOHNSON PHONE NO : 916-677-1912
9085 FOOTHILLS BLVD. SE DECISION MADE: 20-APR-04
ROSEVILLE, CA 95747 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY
NICHOLS INSTITUTE DIAGNOSTICS 510(k) NO: K033727(TRADITIONAL)
ATTN: ROBERT L SCHMIDT PHONE NO : 949-940-7417
1311 CALLE BATIDO SE DECISION MADE: 22-APR-04
SAN CLEMENTE, CA 92673 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MARK 5 NUVO OCSI (M5C5), MODELS 505 AND 950
NIDEK MEDICAL PRODUCTS, INC. 510(k) NO: K040892(SPECIAL)
ATTN: JENNIFER MCWILLIAMS PHONE NO : 205-856-7200
3949 VALLEY EAST INDUSTRIAL DR SE DECISION MADE: 29-APR-04
BIRMINGHAM, AL 35217 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOBEL BIOCARE PERMANENT CENTRIC POST, MODELS 31234, 31235, 31236
NOBEL BIOCARE USA, INC. 510(k) NO: K040573(TRADITIONAL)
ATTN: ELIZABETH J MASON PHONE NO : 714-282-4800
22715 SAVI RANCH PKWY. SE DECISION MADE: 28-APR-04
YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NSI HEXED AND NON-HEXED IMPLANT SYSTEM AND IMMEDIATE LOADING
NORTHERN IMPLANTS, LLC 510(k) NO: K033171(TRADITIONAL)
ATTN: GRETA HOLS PHONE NO : 703-278-3953
10565 LEE HIGHWAY SE DECISION MADE: 27-APR-04
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
FAIRFAX, VA 22030
DEVICE: OSTEOSORB TACK FIXATION SYSTEM
NOVIACE CORPORATION 510(k) NO: K030989(TRADITIONAL)
ATTN: ALBERT ENAYATI PHONE NO : 201-444-7306
809 CARTER LANE SE DECISION MADE: 01-APR-04
PARAMUS, NJ 07652 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUVASIVE SPINAL SYSTEM
NUVASIVE, INC. 510(k) NO: K033546(TRADITIONAL)
ATTN: LAETITIA BERNARD PHONE NO : 858-527-1918
10065 OLD GROVE RD. SE DECISION MADE: 12-APR-04
SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUVASIVE NEUROVISION JJB SYSTEM
NUVASIVE, INC. 510(k) NO: K040543(SPECIAL)
ATTN: LAETITIA BERNARD PHONE NO : 858-271-7070
10065 OLD GROVE RD. SE DECISION MADE: 01-APR-04
SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONEVIEW INTERFACE
NXSTAGE MEDICAL, INC. 510(k) NO: K040074(TRADITIONAL)
ATTN: NORMA LEMAY PHONE NO : 978-687-4700
439 SOUTH UNION ST., 5TH FLOOR SE DECISION MADE: 08-APR-04
LAWRENCE, MA 01843 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM
OHMEDA MEDICAL 510(k) NO: K040068(TRADITIONAL)
ATTN: ALBERTO F PROFUMO PHONE NO : 410-381-4004
8880 GORMAN RD. SE DECISION MADE: 16-APR-04
LAUREL, MD 20723 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLYMPUS HDL CHOLESTEROL REAGENT, OSR6195/OSR6295 AND OLYMPUS HDL
OLYMPUS AMERICA, INC. 510(k) NO: K040692(SPECIAL)
ATTN: MICHAEL CAMPBELL PHONE NO : 972-556-9697
3131 WEST ROYAL LN. SE DECISION MADE: 08-APR-04
IRVING, TX 75063-3104 510(k) STATEMENT
DEVICE: BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM
OLYMPUS CORPORATION 510(k) NO: K040940(TRADITIONAL)
ATTN: TINA STEFFANIE-OAK PHONE NO : 631-844-5477
TWO CORPORATE CENTER DRIVE SE DECISION MADE: 19-APR-04
MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: THE GNATHOMETER
ORTHO GNATHICS LLC 510(k) NO: K033092(TRADITIONAL)
ATTN: KENNETH J POLK PHONE NO : 412-683-8488
5001 BAUM BOULEVARD SE DECISION MADE: 21-APR-04
SUITE 799 510(k) STATEMENT
PITTSBURGH, PA 15213
DEVICE: PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU
OSCOR INC. 510(k) NO: K040569(SPECIAL)
ATTN: MILA DOSKOCIL PHONE NO : 727-937-2511
3816 DE SOTO BLVD. SE DECISION MADE: 07-APR-04
PALM HARBOR, FL 34683 510(k) STATEMENT
DEVICE: OTTER SAFETY SYRINGE
OTTER (CHINA) TECHNOLOGY CO., LTD.510(k) NO: K040545(TRADITIONAL)
ATTN: ELAINE DUNCAN PHONE NO : 715-549-6035
PO BOX 560 SE DECISION MADE: 22-APR-04
STILLWATER, MN 55082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOBILE OXYGEN STORAGE TANK (MOST)
PACIFIC CONSOLIDATED INDUSTRIES LL510(k) NO: K040738(TRADITIONAL)
ATTN: TARIK NAHEIRI PHONE NO : 714-979-9300
3430 WEST CARRIAGE DR. SE DECISION MADE: 30-APR-04
SANTA ANA, CA 92704 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE CARDIOP-B SYSTEM
PAIEON, INC. 510(k) NO: K030139(TRADITIONAL)
ATTN: OMER BARLEV PHONE NO : 212-838-4646
747 THIRD AVE., 4TH FLOOR SE DECISION MADE: 02-APR-04
NEW YORK, NY 10017-2803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PALOMAR LUXV HANDPIECE
PALOMAR MEDICAL TECHNOLOGIES, INC.510(k) NO: K040081(TRADITIONAL)
ATTN: MARCY MOORE PHONE NO : 919-363-2432
131 KELEKENT LN. SE DECISION MADE: 01-APR-04
CARY, NC 27511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PARKELL RESIN GLAZE
PARKELL, INC. 510(k) NO: K040599(TRADITIONAL)
ATTN: NELSON J GENDUSA PHONE NO : 631-249-1134
155 SCHMITT BLVD. SE DECISION MADE: 09-APR-04
P.O. BOX 376 510(k) SUMMARY AVAILABLE FROM FDA
FARMINGDALE, NY 11735
DEVICE: PMH 5000 HEATED HUMIDIFIER FOR RESPIRATORY THERAPY
PEGASUS RESEARCH CORP. 510(k) NO: K020700(TRADITIONAL)
ATTN: KENNETH G MILLER PHONE NO : 714-541-8322
1714 SOUTH LYON ST. SE DECISION MADE: 26-APR-04
SANTA ANA, CA 92705 510(k) STATEMENT
DEVICE: PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM
PENNER MANUFACTURING, INC. 510(k) NO: K040772(TRADITIONAL)
ATTN: VICKIE J BRADY PHONE NO : 402-636-8230
1500 WOODMEN TOWER SE DECISION MADE: 05-APR-04
OHAHA, NE 68102 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: PERFECT SAFETY SYRINGE
PERFECT MEDICAL INDUSTRY CO., LTD.510(k) NO: K030604(TRADITIONAL)
ATTN: ERIC LUO PHONE NO : 214-632-0636
6833 SAINT LAWRENCE ST. SE DECISION MADE: 30-APR-04
PLANO, TX 75024 510(k) STATEMENT
DEVICE: K-Y BRAND WARMING JELLY PERSONAL LUBRICANT
PERSONAL PRODUCTS COMPANY, DIV. OF510(k) NO: K040164(TRADITIONAL)
ATTN: MARYLOU P CARLSON PHONE NO : 908-904-3706
199 GRANDVIEW RD. SE DECISION MADE: 05-APR-04
SKILLMAN, NJ 08558-9418 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: K-Y BRAND WARMING ULTRAGEL PERSONAL LUBRICANT
PERSONAL PRODUCTS COMPANY, DIV. OF510(k) NO: K040340(TRADITIONAL)
ATTN: MARYLOU (PANICO) CARLSON PHONE NO : 908-904-3709
199 GRANDVIEW RD. SE DECISION MADE: 28-APR-04
SKILLMAN, NJ 08558-9418 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHILIPS ANESTHESIA GAS MONITOR, MODEL M1026B
PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K040917(SPECIAL)
ATTN: HERBERT VAN DYK PHONE NO : 49 703 14631734
HEWLETT-PACKARD STR.2 SE DECISION MADE: 29-APR-04
BOEBLINGEN, GERMANY D 71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHOENIX INFUSION CATHETER
PHOENIX BIOMEDICAL 510(k) NO: K033017(TRADITIONAL)
ATTN: COURTNEY SMITH PHONE NO : 610-539-9300
PO BOX 80390 SE DECISION MADE: 07-APR-04
2495 GENERAL ARMISTEAD AVE 510(k) STATEMENT
VALLEY FORGE, PA 19484
DEVICE: LASERPRO CO2 CARBON DIOXIDE LASER SYSTEM
PHOTOMEDEX, INC. 510(k) NO: K040234(TRADITIONAL)
ATTN: BOB ROSE PHONE NO : 760-602-3300
147 KEYSTONE DRIVE SE DECISION MADE: 02-APR-04
MONTGOMERYVILLE, PA 18936 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CADIMPLANT
PRAXIM INC 510(k) NO: K040224(TRADITIONAL)
ATTN: CHRISTINE MEEHAN PHONE NO : 508-660-1952
486 HIGH PLAIN ST. SE DECISION MADE: 06-APR-04
WALPOLE, MA 02081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRODOSE AAD SYSTEM
PROFILE THERAPEUTICS PLC 510(k) NO: K030747(ABBREVIATED)
ATTN: PAUL DRYDEN PHONE NO : 317-335-3780
6329 W. WATERVIEW CT. SE DECISION MADE: 22-APR-04
MCCORDSVILLE, IN 46055-9501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATI
PT. MEDISAFE TECHNOLOGIES 510(k) NO: K040607(TRADITIONAL)
ATTN: ANIL TANEJA PHONE NO : 62 061 4515834
JL. KAPT. PATTIMURA NO. 23 SE DECISION MADE: 22-APR-04
MEDAN, NORTH SUMATRA, INDONESIA 20510(k) STATEMENT
DEVICE: MODIFICATION TO LTV 1000 VENTILATOR
PULMONETIC SYSTEMS, INC. 510(k) NO: K040540(SPECIAL)
ATTN: ROBERT C SAMEC PHONE NO : 763-398-8305
17400 MEDINA RD. SE DECISION MADE: 29-APR-04
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
MINNEAPOLIS, MN 55447
DEVICE: PULPDENT VLC RESIN CEMENT
PULPDENT CORPORATION 510(k) NO: K040236(TRADITIONAL)
ATTN: KENNETH J BERK PHONE NO : 617-926-6666
80 OAKLAND ST. SE DECISION MADE: 20-APR-04
WATERTOWN, MA 02472 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERSONAL WARMING LUBRICANT
QUALIS, INC. 510(k) NO: K040085(TRADITIONAL)
ATTN: MIKE PETERSON PHONE NO : 515-243-3000
4600 PARK AVE. SE DECISION MADE: 20-APR-04
DES MOINES, IA 50321 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTUM CEMENT RESTRICTOR
QUANTUM ORTHOPEDICS 510(k) NO: K040276(TRADITIONAL)
ATTN: JASON BLAIN PHONE NO : 858-451-8698
11662 CORTE GUERA SE DECISION MADE: 30-APR-04
SAN DIEGO, CA 92128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTIPORT MANIFOLD SET WITH SWABABLE VALVES, MODEL 9900
QUEST MEDICAL, INC. 510(k) NO: K040385(ABBREVIATED)
ATTN: KATHRYN J THOMPSON PHONE NO : 972-390-9800
ONE ALLENTOWN PKWY. SE DECISION MADE: 07-APR-04
ALLEN, TX 75002 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: QUICKVUE ADVANCE PH AND AMINES GLL TEST
QUIDEL CORP. 510(k) NO: K040008(TRADITIONAL)
ATTN: JENNIFER S HANKARD PHONE NO : 858-552-7910
10165 MCKELLAR CT. SE DECISION MADE: 29-APR-04
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESECT MEDICAL INLINE BI-POLAR RF LINEAR COAGULATION DEVICE
RESECT MEDICAL, INC. 510(k) NO: K040763(TRADITIONAL)
ATTN: NANCY LINCE PHONE NO : 650-759-6186
40874 CALIDO PLACE SE DECISION MADE: 08-APR-04
FREMONT, CA 94539 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: OXYGEN DIVERTER VALVE
RESMED LTD. 510(k) NO: K033914(TRADITIONAL)
ATTN: DAVID D'CRUZ PHONE NO : 858-746-2400
14040 DANIELSON ST. SE DECISION MADE: 22-APR-04
POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESMED HOSPITAL NASAL MASK
RESMED LTD. 510(k) NO: K040566(SPECIAL)
ATTN: DAVID D'CRUZ PHONE NO : 858-746-2238
14040 DANIELSON ST. SE DECISION MADE: 02-APR-04
POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION OF: SPHERO FLEX, PIVOT FLEX, AND SPHERO BLOCK
RHEIN 83 SRL 510(k) NO: K033630(SPECIAL)
ATTN: JOSEPH E GRASSO PHONE NO : 860-677-9270
132 MONROE ST. SE DECISION MADE: 21-APR-04
HOBOKEN, NJ 07030 510(k) STATEMENT
DEVICE: MESACUP TEST PR-3
RHIGENE, INC. 510(k) NO: K040711(TRADITIONAL)
ATTN: NANCI DEXTER PHONE NO : 303-457-4345
12061 TEJON ST. SE DECISION MADE: 02-APR-04
WESTMINSTER, CO 80234 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAUTION CONDOMS
RICHARD VAN HAUSSEN AMERICA, INC. 510(k) NO: K033163(TRADITIONAL)
ATTN: RICHARD QUAISON PHONE NO : 310-568-1850
5777 W. CENTURY BLVD. SE DECISION MADE: 27-APR-04
#1648 510(k) SUMMARY AVAILABLE FROM FDA
LOS ANGELES, CA 90045
DEVICE: RITA SYSTEMS
RITA MEDICAL SYSTEMS 510(k) NO: K040989(TRADITIONAL)
ATTN: DARRIN UECKER PHONE NO : 650-314-3433
967 NORTH SHORELINE BLVD. SE DECISION MADE: 28-APR-04
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ENDOSCOUT
ROBIN MEDICAL, INC. 510(k) NO: K033485(TRADITIONAL)
ATTN: BENNY ARAZY PHONE NO : 972 4 9940337
MIZPE AVIV SE DECISION MADE: 20-APR-04
INDUSTRIAL PARK 13 510(k) STATEMENT
M.P. MISGAV, ISRAEL 20187
DEVICE: CALIBRATOR FOR AUTOMATED SYSTEMS PROTEINS IN URINE/CSF
ROCHE DIAGNOSTICS CORP. 510(k) NO: K040264(TRADITIONAL)
ATTN: SHERRI L COENEN PHONE NO : 317-521-3831
9115 HAGUE RD. SE DECISION MADE: 02-APR-04
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCU-CHEK GO SYSTEM
ROCHE DIAGNOSTICS CORP. 510(k) NO: K040796(SPECIAL)
ATTN: SCOTT THIEL PHONE NO : 800-428-5074
9115 HAGUE RD. SE DECISION MADE: 22-APR-04
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRASONIC SCALER ELEGANCE MS-10 (25K)
ROLENCE ENTEPRISE, INC. 510(k) NO: K040396(TRADITIONAL)
ATTN: STERLING CHENG PHONE NO : 886 3 4631999
18-3, LANE 231 SE DECISION MADE: 22-APR-04
PU-CHUNG ROAD 510(k) STATEMENT
CHUNGI, CHINA (TAIWAN) 320
DEVICE: MINI L.E.D. OEM MODULE
SATELEC 510(k) NO: K040808(TRADITIONAL)
ATTN: JACKIE MASSE PHONE NO : 781-239-8108
70 WALNUT ST. SE DECISION MADE: 28-APR-04
WELLESLEY, MA 02481 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIOVIT AT-102
SCHILLER AG 510(k) NO: K031557(TRADITIONAL)
ATTN: MARKUS BUETLER PHONE NO : 41 41 766 4242
ALTGASSE 68 SE DECISION MADE: 14-APR-04
BAAR, SWITZERLAND CH-6341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RABBIT
SCION INTERNATIONAL, INC. 510(k) NO: K040087(TRADITIONAL)
ATTN: C. KENNETH FRENCH PHONE NO : 254-435-2306
7930 HWY 22 SE DECISION MADE: 01-APR-04
MERIDIAN, TX 76665 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NORMAL AND HYPERGAMMA CONTROL SERUM
SEBIA 510(k) NO: K040925(TRADITIONAL)
ATTN: BOREK JANIK PHONE NO : 734-475-2441
13805 WATERLOO SE DECISION MADE: 28-APR-04
CHELSEA, MI 48118 510(k) STATEMENT
DEVICE: GEL MARK IV
SENORX, INC. 510(k) NO: K040706(SPECIAL)
ATTN: AMY BOUCLY PHONE NO : 949-362-4800
11 COLUMBIA, SUITE A SE DECISION MADE: 08-APR-04
ALISO VIEJO, CA 92656 510(k) STATEMENT
DEVICE: SENORX BIOPSY DEVICE II
SENORX, INC. 510(k) NO: K040842(SPECIAL)
ATTN: AMY BOUCLY PHONE NO : 949-362-4800
11 COLUMBIA, SUITE A SE DECISION MADE: 30-APR-04
ALISO VIEJO, CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOMATOM SENSATION 64 AND SENSATION CARDIAC
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K040665(SPECIAL)
ATTN: NEALIE HARTMANN PHONE NO : 601-448-1769
51 VALLEY STREAM PKWY. SE DECISION MADE: 02-APR-04
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONA PILLOW
SLEEP DEVICES, INC. 510(k) NO: K040161(TRADITIONAL)
ATTN: NAJEEB A ZUBERI PHONE NO : 407-935-1008
720 WEST OAK STREET SE DECISION MADE: 30-APR-04
SUITE 210 510(k) STATEMENT
KISSIMMEE, FL 34741
DEVICE: VERSABOND AB BONE CEMENT
SMITH & NEPHEW, INC. 510(k) NO: K022688(ABBREVIATED)
ATTN: DAVID HENLEY PHONE NO : 901-396-2121
1450 E. BROOKS RD. SE DECISION MADE: 29-APR-04
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH AND NEPHEW TITANIUM INTERFERENCE SCREWS
SMITH & NEPHEW, INC. 510(k) NO: K040331(TRADITIONAL)
ATTN: DENISE LIMA PHONE NO : 508-337-4036
150 MINUTEMAN RD. SE DECISION MADE: 14-APR-04
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM, MODEL SW4000
SMITHS MEDICAL ASD, INC. 510(k) NO: K040632(SPECIAL)
ATTN: VERNON TRIMBLE PHONE NO : 781-878-8011
160 WEYMOUTH ST. SE DECISION MADE: 27-APR-04
ROCKLAND, MA 02370 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO PARIETEX COMPOSITE (PCO) MESH
SOFRADIM PRODUCTION 510(k) NO: K040998(SPECIAL)
ATTN: MARY MCNAMARA-CULLINANE, RAPHONE NO : 508-643-0434
49 PLAIN ST. SE DECISION MADE: 29-APR-04
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-VIEW
SOMETECH CORPORATION 510(k) NO: K024186(TRADITIONAL)
ATTN: KI CHEOL HAN PHONE NO : 770-825-0100
6669 PEACHTREE INDUSTRIAL BLVD SE DECISION MADE: 01-APR-04
SUITE J 510(k) SUMMARY AVAILABLE FROM FDA
NORCROSS, GA 30092
DEVICE: E-Z SCAN AB5500+
SONOMED, INC. 510(k) NO: K040668(SPECIAL)
ATTN: GEORGE MYERS PHONE NO : 201-727-1703
377 ROUTE 17 S SE DECISION MADE: 13-APR-04
HANSBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINRAY
SOREDEX INSTRUMENTARIUM CORP. 510(k) NO: K033755(TRADITIONAL)
ATTN: KAI LANER PHONE NO : 358 10 394820
ELIMAENKATU 22 SE DECISION MADE: 29-APR-04
HELSINKI, FINLAND FIN 00510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: .DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATOR
SOUTHEASTERN RADIATION PRODUCTS, I510(k) NO: K040804(TRADITIONAL)
ATTN: RICHARD SWEAT PHONE NO : 407-330-3300
2651 N. DESIGN COURT SE DECISION MADE: 28-APR-04
SANFORD, FL 32773 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RIVA LUTING
SOUTHERN DENTAL INDUSTRIES, INC. 510(k) NO: K040393(TRADITIONAL)
ATTN: SAMANTHA J CHEETHAM PHONE NO : 630-238-8300
729 N. ROUTE 83, SUITE 315 SE DECISION MADE: 30-APR-04
BENSENVILLE, IL 60106 510(k) STATEMENT
DEVICE: QUIESCENCE
SPECTRAL VISUALIZATION & DEVELOPME510(k) NO: K040330(TRADITIONAL)
ATTN: DENNIS WOO PHONE NO : 506 460 1625
921 COLLEGE HILL RD. SE DECISION MADE: 12-APR-04
FREDERICTON, NEW BRUNSWICK, CANADA510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLIRPATH EXCIMER LASER CATHETER
SPECTRANETICS CORP. 510(k) NO: K040067(TRADITIONAL)
ATTN: ADRIAN ELFE PHONE NO : 719-633-8333
96 TALAMINE CT. SE DECISION MADE: 27-APR-04
COLORADO SPRINGS, CO 80907-5159 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALTA LR FIXED TIP CHRONIC HEMODIALYSIS CATHETER, MODELS AL19NH24
SPIRE BIOMEDICAL INC 510(k) NO: K040509(SPECIAL)
ATTN: DONALD FICKETT PHONE NO : 781-275-6001
ONE PATRIOTS PARK SE DECISION MADE: 19-APR-04
BEDFORD, MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUREX STUDDED/RIBBED LUBRICATED LATEX CONDOM
SSL AMERICAS 510(k) NO: K040185(ABBREVIATED)
ATTN: KATHLEEN J HARRIS PHONE NO : 770-582-2152
3585 ENGINEERING DR. SE DECISION MADE: 27-APR-04
NORCROSS, GA 30092 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230)
STELLARTECH RESEARCH CORP. 510(k) NO: K040240(SPECIAL)
ATTN: JAMES R SANTOS PHONE NO : 408-331-3145
1346 BORDEAUX DR. SE DECISION MADE: 01-APR-04
SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER T4 HYTREL ZIPPER TOGA
STRYKER CORP. 510(k) NO: K040764(SPECIAL)
ATTN: JENNIFER MARS PHONE NO : 269-323-7700
4100 E. MILHAM AVE. SE DECISION MADE: 27-APR-04
KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER RF ELECTRODES AND CANNULAE
STRYKER INSTRUMENTS 510(k) NO: K032406(TRADITIONAL)
ATTN: NICOLE PETTY PHONE NO : 269-323-7700
4100 EAST MILHAM AVE. SE DECISION MADE: 01-APR-04
KALAMAZOO, MI 49001 510(k) STATEMENT
DEVICE: STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
STRYKER INSTRUMENTS 510(k) NO: K040369(TRADITIONAL)
ATTN: JEAN W SHEPPARD PHONE NO : 269-323-7700
4100 EAST MILHAM AVE. SE DECISION MADE: 01-APR-04
KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REFLEX HYBRID ANTERIOR CERVICAL PLATE SYSTEM
STRYKER SPINE 510(k) NO: K040261(SPECIAL)
ATTN: SIMONA VOIC PHONE NO : 201-760-8145
6 PEARL COURT SE DECISION MADE: 16-APR-04
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELEMENTS OBTURATION UNIT
SYBRON ENDO/ANALYTIC 510(k) NO: K031664(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
15233 N.E. 90TH ST. SE DECISION MADE: 28-APR-04
REDMOND, WA 98052 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROVASCULAR ANASTOMOTIC DEVICE
SYNOVIS MICRO COMPANIES ALLIANCE, 510(k) NO: K040163(TRADITIONAL)
ATTN: DAISY P SIN PHONE NO : 651-796-7300
439 INDUSTRIAL LN. SE DECISION MADE: 16-APR-04
BIRMINGHAM, AL 35211-4464 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGU
SYNOVIS SURGICAL INNOVATIONS 510(k) NO: K040415(TRADITIONAL)
ATTN: ANGELA MALLERY PHONE NO : 651-796-7372
2575 UNIVERSITY AVE. WEST SE DECISION MADE: 14-APR-04
ST. PAUL, MN 55114-1024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES MANDIBLE EXTERNAL FIXATOR
SYNTHES (USA) 510(k) NO: K040169(TRADITIONAL)
ATTN: SHERI L MUSGNUNG PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 14-APR-04
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM
SYNTHES (USA) 510(k) NO: K040336(TRADITIONAL)
ATTN: SHERI MUSGNUNG PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 12-APR-04
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES (USA) TIBIAL NAIL SYSTEM EX
SYNTHES (USA) 510(k) NO: K040762(TRADITIONAL)
ATTN: SHERI L MUSGNUNG PHONE NO : 610-647-9700
P.O. BOX 1766 SE DECISION MADE: 12-APR-04
1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301-1222
DEVICE: SYNTHES 5.0/7.3 MM CANNULATED LOCKING SCREWS
SYNTHES (USA) 510(k) NO: K040765(TRADITIONAL)
ATTN: LISA M BOYLE PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 12-APR-04
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES AFS
SYNTHES SPINE 510(k) NO: K032534(TRADITIONAL)
ATTN: JOHN WALSH PHONE NO : 484-356-9621
1230 WILSON DRIVE SE DECISION MADE: 01-APR-04
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TAI SHENG VARIOUS NEOX POWERED MUSCLE STIMULATOR
TAI SHENG ELECTRICAL MACHINERY CO.510(k) NO: K031310(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 12-APR-04
HSIN-CHU CITY, CHINA (TAIWAN) 510(k) STATEMENT
DEVICE: TANITA SEGMENTAL BODY COMPOSITION ANALYZER, MODEL BC-418
TANITA CORP. OF AMERICA 510(k) NO: K033157(TRADITIONAL)
ATTN: RHODA LYNN VALERA PHONE NO : 847-434-3966
2625 SOUTH CLEARBROOK DR. SE DECISION MADE: 08-APR-04
ARLINGTON HGTS., IL 60005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TERATECH MODEL 10V5 SMART PROBE
TERATECH CORP. 510(k) NO: K040840(TRADITIONAL)
ATTN: CHARLES F HOTTINGER PHONE NO : 206-780-7945
PO BOX 10074 SE DECISION MADE: 14-APR-04
13221 NE TEEM LOOP ROAD 510(k) SUMMARY AVAILABLE FROM FDA
BAINBRIDGE ISLAND, WA 98110 THIRD PARTY REVIEW
DEVICE: ANSPACH MRI SAFE SURGICAL DRILL SYSTEM
THE ANSPACH EFFORT, INC. 510(k) NO: K040186(TRADITIONAL)
ATTN: WILLIAM G CONETY PHONE NO : 561-627-1080
4500 RIVERSIDE DR. SE DECISION MADE: 15-APR-04
PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 1187
THE FIRST YEARS, INC. 510(k) NO: K032845(TRADITIONAL)
ATTN: ROBIN C CONNOR PHONE NO : 508-588-1220
ONE KIDDIE DR. SE DECISION MADE: 05-APR-04
AVON, MA 02322 510(k) STATEMENT
DEVICE: CERAMIC TIPPED SKULL PIN
THE JEROME GROUP, INC. 510(k) NO: K040363(TRADITIONAL)
ATTN: RONALD KOWALSKI PHONE NO : 856-234-8600
305 HARPER DR. SE DECISION MADE: 12-APR-04
MOORESTOWN, NJ 08057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE STRAUMANN ORTHO IMPLANT SYSTEM
THE STRAUMANN CO. 510(k) NO: K040469(TRADITIONAL)
ATTN: CAROLYN BITETTI PHONE NO : 800-448-8168
RESERVOIR PL. 1601 TRAPELO RD. SE DECISION MADE: 30-APR-04
WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: "BACK IN ACTION" COMPRESSION & SUPPORT WITH MAGNETS FOR THE LOWE
THEODORE BARASH 510(k) NO: K040054(TRADITIONAL)
ATTN: THEODORE BARASH PHONE NO : 561-498-8926
16879 C ISLE OF PALMS DRIVE SE DECISION MADE: 27-APR-04
DELRAY BEACH, FL 33484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMAGE-ARENA AND RESEARCH-ARENA APPLICATIONS
TOMTEC IMAGING SYSTEMS, GMBH 510(k) NO: K040546(TRADITIONAL)
ATTN: RALF JANITZ PHONE NO : 49 89 32175830
EDISONSTRASSE 6 SE DECISION MADE: 27-APR-04
UNTERSCHLEISSHEIM, GERMANY D-85716510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 5M MEDICAL FLAT PANEL DISPLAY, ME511L
TOTOKU ELECTRIC CO., LTD 510(k) NO: K031661(TRADITIONAL)
ATTN: MIKIO HASEGAWA PHONE NO : 011 81 268345484
300 OYA , UEDA-SHI, SE DECISION MADE: 23-APR-04
NAGANO-KEN, JAPAN 386-0192 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES
TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K040619(TRADITIONAL)
ATTN: CYNTHIA C KNAPP PHONE NO : 800-871-8909
982 KEYNOTE CIRCLE SUITE 6 SE DECISION MADE: 07-APR-04
CLEVELAND, OH 44131 510(k) STATEMENT
DEVICE: SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES
TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K040846(TRADITIONAL)
ATTN: CYNTHIA C KNAPP PHONE NO : 800-871-8909
982 KEYNOTE CIRCLE SUITE 6 SE DECISION MADE: 26-APR-04
CLEVELAND, OH 44131 510(k) STATEMENT
DEVICE: SURGICAL FACE MASK - COLORS: WHITE, YELLOW, PINK, BLUE, AND GREE
TUCKER & ASSOCIATES 510(k) NO: K022256(TRADITIONAL)
ATTN: JANNA TUCKER PHONE NO : 775-342-2612
198 AVE. DE LA D'EMERALD SE DECISION MADE: 26-APR-04
SPARKS, NV 89434-9550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KENDALL ULTEC PRO AG+ HYDROCOLLOID DRESSING
TYCO HEALTHCARE 510(k) NO: K033453(TRADITIONAL)
ATTN: GAIL CHRISTIE PHONE NO : 508-261-8440
15 HAMPSHIRE ST. SE DECISION MADE: 29-APR-04
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLICK-ON
UNOMEDICAL A/S 510(k) NO: K040633(SPECIAL)
ATTN: JOHN M LINDSKOG PHONE NO : 454 642 7810
AAHOLMVEJ 1-3, OSTED SE DECISION MADE: 01-APR-04
ROSKILDE, DENMARK DK-4000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER INTERVENTIONAL PAIN RF GENERATOR
VALLEY FORGE SCIENTIFIC CORP. 510(k) NO: K032601(TRADITIONAL)
ATTN: JERRY MALIS PHONE NO : 610-666-7500
136 GREEN TREE RD. SE DECISION MADE: 01-APR-04
OAKS, PA 19456 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
VANGUARD MEDICAL CONCEPTS, INC. 510(k) NO: K031687(TRADITIONAL)
ATTN: HEATHER CRAWFORD PHONE NO : 863-683-8680
5307 GREAT OAK DR. SE DECISION MADE: 30-APR-04
LAKELAND, FL 33815 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MASTERSCREEN CPX AND OXYCON CPX
VIASYS HEALTHCARE GMBH 510(k) NO: K040698(SPECIAL)
ATTN: EDMOND CHU PHONE NO : 714-283-2228
22705 SAVI RANCH PKWY. SE DECISION MADE: 07-APR-04
YORBA LINDA, CA 92887 510(k) STATEMENT
DEVICE: VIATRONIX V3D COLON, REVISION 1.3
VIATRONIX, INC. 510(k) NO: K040126(TRADITIONAL)
ATTN: BAMAN PATTANAYAK PHONE NO : 631-444-9687
25 EAST LOOP RD., SUITE 204 SE DECISION MADE: 19-APR-04
STONY BROOK, NY 11790 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISION-SCIENCES CST-2000 FLEXIBLE CYSTOSCOPE WITH SLIDE-ON ENDOS
VISION-SCIENCES, INC. 510(k) NO: K040215(TRADITIONAL)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552
5 WHITCOMB AVE. SE DECISION MADE: 15-APR-04
AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISION SCIENCES MODEL ENT-2000V FLEXIBLE NASOPHARYNGO-LARYNGOSCO
VISION-SCIENCES, INC. 510(k) NO: K040984(SPECIAL)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552
5 WHITCOMB AVE. SE DECISION MADE: 27-APR-04
AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ICONNECTION, VERSION 3.2.0.0 MEDICAL IMAGE PROCESSING SOFTWARE
VITAL IMAGES, INC. 510(k) NO: K040876(TRADITIONAL)
ATTN: TIMOTHY J KAPPERS PHONE NO : 763-852-6914
3300 FERNBROOK LN. NORTH SE DECISION MADE: 19-APR-04
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
PLYMOUTH, MN 55447 THIRD PARTY REVIEW
DEVICE: STRUCTUR 2 SC
VOCO GMBH 510(k) NO: K040769(SPECIAL)
ATTN: GERALD W SHIPPS PHONE NO : 541-389-5935
19379 BLUE LAKE LOOP SE DECISION MADE: 07-APR-04
BEND, OR 97702 510(k) STATEMENT
DEVICE: PACKAGING TRAY AND COMPONENTS
VYGON US LLC 510(k) NO: K040707(SPECIAL)
ATTN: COURTNEY SMITH PHONE NO : 610-539-9300
2495 GENERAL ARMSTEAD AVE. SE DECISION MADE: 16-APR-04
NORRISTOWN, PA 19403 510(k) STATEMENT
DEVICE: AUTOKIT TOTAL KETONE BODIES KIT (SERUM) AND WAKO KETONE BODY CAL
WAKO CHEMICALS, USA, INC. 510(k) NO: K033860(TRADITIONAL)
ATTN: TONYA MALLORY PHONE NO : 877-714-1924
1600 BELLWOOD RD. SE DECISION MADE: 23-APR-04
RICHMOND, VA 23237 510(k) STATEMENT
DEVICE: CALYSTO IMAGE IV-IMAGE AND INFORMATION MANAGEMENT SYSTEM
WITT BIOMEDICAL CORP 510(k) NO: K040195(TRADITIONAL)
ATTN: ELFRIEDE PAGAN PHONE NO : 321-421-1146
305 NORTH DR. SE DECISION MADE: 07-APR-04
MELBOURNE, FL 32934 510(k) STATEMENT
DEVICE: OSTEOSET DBM PELLETS, MODEL 8600-48XX
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K022828(TRADITIONAL)
ATTN: ROGER D BROWN PHONE NO : 901-867-4457
5677 AIRLINE RD. SE DECISION MADE: 02-APR-04
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DERMAGRIP-G, AND MULTIPLE CUSTOMERS TRADE NAME GREEN, ALOE VERA
WRP ASIA PACIFIC SDN. BHD. 510(k) NO: K040645(TRADITIONAL)
ATTN: TERENCE LIM PHONE NO : 60 3 87061486
LOT 1, JALAN 3, SE DECISION MADE: 28-APR-04
KAWASAN PERUSAHAAN BANDAR BARU 510(k) STATEMENT
SALAK TINGGI, SEPANG SELANGOR, MALAYSIA 43900
DEVICE: WU'S 4-WHEELED NEO SCOOTER, MODEL WT-T4D
WU'S TECH CO., LTD. 510(k) NO: K040968(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 30-APR-04
HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMLUCK YA HORNG PC COMPATIBLE WRIST BLOOD PRESSURE MONITOR, MODE
YA HORNG ELECTRONIC CO., LTD. 510(k) NO: K040528(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 3 5208829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 15-APR-04
HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: YUE PFONG SAFETY SYRINGE (3ML)
YUE PFONG INTERNATIONAL INDUSTRIAL510(k) NO: K040105(TRADITIONAL)
ATTN: JENNIFER REICH PHONE NO : 928-773-9488
3892 SOUTH AMERICA WEST TRAIL SE DECISION MADE: 07-APR-04
FLAGGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOCATOR BAR FEMALE, LOCATOR LASER BAR FEMALE, LOCATOR BAR CAST-T
ZEST ANCHORS, INC. 510(k) NO: K033699(TRADITIONAL)
ATTN: FLOYD G LARSON PHONE NO : 858-792-1235
4329 GRAYDON ROAD SE DECISION MADE: 22-APR-04
SAN DIEGO, CA 92130 510(k) STATEMENT
DEVICE: ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MPO/PR3 IGG TEST SYSTEM
ZEUS SCIENTIFIC, INC. 510(k) NO: K040111(TRADITIONAL)
ATTN: MARK J KOPNITSKY PHONE NO : 908-526-3744
200 EVANS WAY SE DECISION MADE: 05-APR-04
BRANCHBURG, NJ 08876 510(k) STATEMENT
DEVICE: DISPOSABLE POWDERED VINYL PATIENT EXAMINATION GLOVES
ZIBO BORUI PLASTIC & RUBBER PRODUC510(k) NO: K040828(TRADITIONAL)
ATTN: HUAN-CHUNG LI PHONE NO : 978-436-9980
17A STERLING ROAD SE DECISION MADE: 19-APR-04
NORTH BILLERICA, MA 01862 510(k) STATEMENT
DEVICE: CRYO 5
ZIMMER ELEKTROMEDIZIN GMBH 510(k) NO: K040727(TRADITIONAL)
ATTN: STEFAN LEINWEBER PHONE NO : 49 731 9761162
JUNKERSSTRASSE 9 SE DECISION MADE: 23-APR-04
NEU-ULM, GERMANY D-89231 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PERIARTICULAR LOCKING PLATES AND SCREWS, 2358, 2359 SERIES
ZIMMER, INC. 510(k) NO: K040593(TRADITIONAL)
ATTN: LAURA D WILLIAMS PHONE NO : 574-372-4523
P.O. BOX 708 SE DECISION MADE: 12-APR-04
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MS-30 FEMORAL STEM STANDARD AND LATERAL
ZIMMER, INC. 510(k) NO: K040803(SPECIAL)
ATTN: ROBERT WOLFARTH PHONE NO : 512-432-9324
9900 SPECTRUM DRIVE SE DECISION MADE: 29-APR-04
AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WELL@HOME SYSTEM
ZOE MEDICAL, INC. 510(k) NO: K040012(TRADITIONAL)
ATTN: STEPHEN STAATS PHONE NO : 978-887-1410
460 BOSTON ST. SE DECISION MADE: 02-APR-04
TOPSFIELD, MA 01983-1223 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 283
TOTAL WITH SUMMARIES 239
TOTAL WITH STATEMENTS 44
Updated May 5, 2004
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