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510(k)s Final Decisions Rendered for October 2005 |
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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-OCT-2005 THROUGH 31-OCT-2005
DEVICE: ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTER
AB BIODISK 510(k) NO: K052366(TRADITIONAL)
ATTN: ANNE BOLMSTROM PHONE NO : 46 8 7300760
DALVAGEN 10 SE DECISION MADE: 13-OCT-05
SOLNA, SWEDEN 16956 510(k) STATEMENT
DEVICE: ZIRACE
ACUCERA, INC. 510(k) NO: K051501(TRADITIONAL)
ATTN: KYUNG-BIN LEE PHONE NO : 820 315 276940
NAMYANGJU-SI SE DECISION MADE: 19-OCT-05
GYEONGGI 510(k) SUMMARY AVAILABLE FROM FDA
SEUL, REPUBLIC OF KOREA 472-861
DEVICE: VITALCAREGIVING SYSTEM
ADVANCED MONITORING CAREGIVING INC510(k) NO: K051544(TRADITIONAL)
ATTN: GEORGE MYERS PHONE NO : 201-727-1703
377 ROUTE 17 S SE DECISION MADE: 07-OCT-05
HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SLIMMANAGER, MODEL SM-X, SM-E
AIIA COMMUNICATION INC. 510(k) NO: K051589(TRADITIONAL)
ATTN: JOHN MYUNG PHONE NO : 847-917-1531
PO BOX 7007 SE DECISION MADE: 31-OCT-05
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR
ALBERT BROWNE LTD. 510(k) NO: K051056(TRADITIONAL)
ATTN: CYNTHIA J M. NOLTE PHONE NO : 508-643-0434
49 PLAIN ST. SE DECISION MADE: 20-OCT-05
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERIFY SPI CHEMICAL INDICATOR
ALBERT BROWNE LTD. 510(k) NO: K052535(TRADITIONAL)
ATTN: CYNTHIA J.M. NOLTE PHONE NO : 919-859-4207
49 PLAIN ST. SE DECISION MADE: 21-OCT-05
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLUCODR SUPERSENSOR SYSTEM
ALL MEDICUS CO., LTD 510(k) NO: K050985(TRADITIONAL)
ATTN: JE YOUNG CHANG PHONE NO : +82 31 4258288
7106 DONG-IL TECHO TOWN 7TH SE DECISION MADE: 07-OCT-05
823 KWANYANG DONG DONGAN-GU 510(k) SUMMARY AVAILABLE FROM FDA
ANYANG, GYEONGGI-DO, REPUBLIC OF KOREA 431-062
DEVICE: COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A; ICY CATHETER
ALSIUS CORP. 510(k) NO: K051912(TRADITIONAL)
ATTN: KENNETH A COLLINS PHONE NO : 949-453-0150
15770 LAGUNA CANYON, SUITE 150 SE DECISION MADE: 11-OCT-05
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ICY CATHETER, MODEL IC-3893A
ALSIUS CORP. 510(k) NO: K052443(TRADITIONAL)
ATTN: KENNETH A COLLINS PHONE NO : 949-453-0150
15770 LAGUNA CANYON, SUITE 150 SE DECISION MADE: 17-OCT-05
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARCTEC SEMIRIGID PLATING SYSTEM
ALTIVA CORP. 510(k) NO: K051044(TRADITIONAL)
ATTN: JOHN KAPTIAN PHONE NO : 704-409-1754
9800-I SOUTHERN PINE BLVD. SE DECISION MADE: 07-OCT-05
CHARLOTTE, NC 28273 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACTICLOT, MODEL 824
AMERICAN DIAGNOSTICA, INC. 510(k) NO: K052124(TRADITIONAL)
ATTN: LEIGH AYRES PHONE NO : 203-602-7777
500 WEST AVENUE SE DECISION MADE: 17-OCT-05
STAMFORD, CT 06902 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPECTRAQUATTRO PULSED LIGHT SYSTEM
AMJET DISTRIBUTION, LLC 510(k) NO: K052336(TRADITIONAL)
ATTN: STEVE TRINTER PHONE NO : 612-812-1636
10255 BERKSHIRE ROAD SE DECISION MADE: 11-OCT-05
MINNEAPOLIS, MN 55437 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ARTHROCARE ARTHROWANDS
ARTHROCARE CORP. 510(k) NO: K052686(SPECIAL)
ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-736-0224
680 VAQUEROS AVE. SE DECISION MADE: 05-OCT-05
SUNNYVALE, CA 94085-3523 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNICAP UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS
ARTHROSURFACE, INC. 510(k) NO: K050373(TRADITIONAL)
ATTN: STEVEN EK PHONE NO : 508-520-3003
28 FORGE PARKWAY SE DECISION MADE: 11-OCT-05
FRANKLIN, MA 02038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTELON SURGICAL SUTURE
ARTIMPLANT AB 510(k) NO: K052482(SPECIAL)
ATTN: MARIE MARLOW PHONE NO : 202-546-1262
719 A STREET NE SE DECISION MADE: 17-OCT-05
WASHINGTON, DC 20002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTSANA PEN NEEDLES, ARTSANA INJECTION NEEDLES
ARTSANA S.P.A. 510(k) NO: K051783(TRADITIONAL)
ATTN: LARA N SIMMONS PHONE NO : 847-682-0224
22411 60TH STREET SE DECISION MADE: 04-OCT-05
BRISTOL, WI 53104 510(k) STATEMENT
DEVICE: STANDARD, SPECIAL, SPECIAL+, S|NEEDLE B-TYPE AND S|NEEDLE J-TYPE
ASIA-MED GMBH AND CO KG 510(k) NO: K052085(SPECIAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412
13 RED FOX LN. SE DECISION MADE: 14-OCT-05
LITTLETON, CO 80127 510(k) STATEMENT
DEVICE: AURA-PSG
ASTRO-MED, INC. 510(k) NO: K050425(TRADITIONAL)
ATTN: MICHAEL J SULLIVAN PHONE NO : 401-828-4000
600 EAST GREENWICH AVE. SE DECISION MADE: 20-OCT-05
WEST WARWICK, RI 02893 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT IN ZIRCO
ATLANTIS COMPONENTS, INC. 510(k) NO: K052070(TRADITIONAL)
ATTN: BETSY A BROWN PHONE NO : 847-560-4406
8944 TAMAROA TERRACE SE DECISION MADE: 14-OCT-05
SKOKIE, IL 60076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATRICURE TRANSPOLAR SYSTEM
ATRICURE, INC. 510(k) NO: K052893(TRADITIONAL)
ATTN: ELSA CHI ABRUZZO PHONE NO : 513-755-4130
6033 SCHUMACHER PARK DR. SE DECISION MADE: 25-OCT-05
WEST CHESTER, OH 45069 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: AXYA MODEL 6500 AXYALOOP SELF-TAPPING BONE ANCHOR
AXYA MEDICAL, INC. 510(k) NO: K052491(SPECIAL)
ATTN: HOWARD L SCHRAYER PHONE NO : 609-924-9510
100 CUMMINGS CENTER SE DECISION MADE: 07-OCT-05
SUITE 444C 510(k) SUMMARY AVAILABLE FROM FDA
BEVERLY, MA 01915
DEVICE: ADVIA CHEMISTRY MICROALBUMIN CONTROLS
BAYER HEALTHCARE LLC 510(k) NO: K052242(ABBREVIATED)
ATTN: ANDRES HOLLE PHONE NO : 914-524-3494
511 BENEDICT AVE. SE DECISION MADE: 03-OCT-05
TARRYTOWN, NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVIA IMS GLUCOSE ASSAY
BAYER HEALTHCARE, LLC 510(k) NO: K052163(TRADITIONAL)
ATTN: ANDRES HOLLE PHONE NO : 914-524-3494
511 BENEDICT AVE. SE DECISION MADE: 11-OCT-05
TARRYTOWN, NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -CIPROFLOXACIN GN
BECTON, DICKINSON & CO. 510(k) NO: K052269(TRADITIONAL)
ATTN: MONICA GIGUERE PHONE NO : 410-316-4287
7 LOVETON CIR. SE DECISION MADE: 03-OCT-05
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFUROXIME (STREP) 0.
BECTON, DICKINSON & CO. 510(k) NO: K052270(TRADITIONAL)
ATTN: MONICA GIGUERE PHONE NO : 410-316-4287
7 LOVETON CIR. SE DECISION MADE: 05-OCT-05
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BELMONT BUDDY FLUID WARMER
BELMONT INSTRUMENT CORP. 510(k) NO: K052547(SPECIAL)
ATTN: URAIWAN P LABADINI PHONE NO : 978-663-0212
780 BOSTON RD. SE DECISION MADE: 13-OCT-05
BILLERICA, MA 01821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE F
BIO-RAD LABORATORIES, INC. 510(k) NO: K043341(TRADITIONAL)
ATTN: CHRISTOPHER BENTSEN PHONE NO : 425-498-1709
6565 185TH AVE., N.E. SE DECISION MADE: 27-OCT-05
REDMOND, WA 98052 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIODERM SCIENCES WOUND CREAM
BIODERM SCIENCES, INC. 510(k) NO: K042352(TRADITIONAL)
ATTN: EDWARD R GUBISH PHONE NO : 301-216-3912
101 ORCHARD RIDGE DR. SE DECISION MADE: 17-OCT-05
SUITE 1N 510(k) SUMMARY AVAILABLE FROM FDA
GAITHERSBURG, MD 20878
DEVICE: FIDIS CONNECTIVE 8
BIOMEDICAL DIAGNOSTICS (BMD) SA 510(k) NO: K050286(TRADITIONAL)
ATTN: COURIVAUD CHRISTELLE PHONE NO : 33 164 621012
ACTIPOLE 25 SE DECISION MADE: 03-OCT-05
4 BLD DE BEAUBOURG 510(k) STATEMENT
MARNE LA VALLEE CX 2, FRANCE 77435
DEVICE: POROUS COATED ACETABULAR COMPONENTS
BIOMET, INC. 510(k) NO: K050124(TRADITIONAL)
ATTN: PATRICIA BERES PHONE NO : 574-267-6639
56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 04-OCT-05
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHOPEDIC SALVAGE SYSTEM- OSS
BIOMET, INC. 510(k) NO: K052685(SPECIAL)
ATTN: ALLISON KOSKEY PHONE NO : 574-267-6639
56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 27-OCT-05
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PIXARRAY 100 DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM
BIOPTICS, INC. 510(k) NO: K052433(TRADITIONAL)
ATTN: JEFFREY ORACH PHONE NO : 520-514-2298
3496 S. DODGE BLVD., SUITE 110 SE DECISION MADE: 18-OCT-05
TUCSON, AZ 85713 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENTERAL FEEDING TUBE
BIOSEARCH MEDICAL PRODUCTS, INC. 510(k) NO: K051480(TRADITIONAL)
ATTN: GENE BOYD PHONE NO : 908-722-5000
35 INDUSTRIAL PKWY. SE DECISION MADE: 12-OCT-05
BRANCHBURG, NJ 08876 510(k) STATEMENT
DEVICE: PHERON PERIPHERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CA
BIOTRONIK AG 510(k) NO: K052757(SPECIAL)
ATTN: JON BRUMBAUGH PHONE NO : 888-345-0374
6024 JEAN ROAD SE DECISION MADE: 28-OCT-05
LAKE OSWEGO, OR 97035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FETAL MONITOR, MODELS BT-300 AND BT-200
BISTOS CO., LTD. 510(k) NO: K052190(TRADITIONAL)
ATTN: CHARLIE MACK PHONE NO : 931-937-8093
340 SHADY GROVE ROAD SE DECISION MADE: 04-OCT-05
FLINTVILLE, TN 37335 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BONART ART-M3II & M4 ULTRASONIC SCALER UNITS WITH ACCESSORIES (I
BONART CO. LTD. 510(k) NO: K052028(TRADITIONAL)
ATTN: ERIC L ONG PHONE NO : 909-594-8066
398 S. LEMON CREEK DR. SE DECISION MADE: 28-OCT-05
STE. L 510(k) SUMMARY AVAILABLE FROM FDA
WALNUT, CA 91789
DEVICE: TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450
BOSTON MEDICAL PRODUCTS, INC. 510(k) NO: K051587(TRADITIONAL)
ATTN: MICHAEL A WARREN PHONE NO : 508-898-9300
117 FLANDERS RD. SE DECISION MADE: 25-OCT-05
WESTBOROUGH, MA 01581 510(k) STATEMENT
DEVICE: MODIFICATION TO: IQ GUIDE WIRE, MODELS 38950-XX. 38951-XX
BOSTON SCIENTIFIC CORP. 510(k) NO: K052783(SPECIAL)
ATTN: DIANE BRINZA PHONE NO : 763-694-3061
ONE SCIMED PLACE SE DECISION MADE: 27-OCT-05
MAPLE GROVE, MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRC SOFTWARE PRODUCT
BRC OPERATIONS PTY LIMITED 510(k) NO: K050192(TRADITIONAL)
ATTN: CARRI GRAHAM PHONE NO : 317-849-1916
7992 CASTLEWAY DRIVE SE DECISION MADE: 20-OCT-05
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWERPICC, POLY PER-Q-CATH, 6 FR TL POLY PER-Q-CATH, POWER HOHN
C.R. BARD, INC. 510(k) NO: K051991(TRADITIONAL)
ATTN: LYNN M KIRCHOFF PHONE NO : 801-595-0700
5425 WEST AMELIA EARHART DR. SE DECISION MADE: 20-OCT-05
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARD LARGE PORE SOFT MESH AND SOFT MESH PRESHAPED
C.R. BARD, INC. 510(k) NO: K052155(TRADITIONAL)
ATTN: LUCINDA L FOX PHONE NO : 401-463-7000
100 SOCKANOSSETT CROSSROAD SE DECISION MADE: 20-OCT-05
CRANSTON, RI 02920 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWERHEART AED G3 (MODEL 9390E), POWERHEART AED G3 AUTOMATIC (MO
CARDIAC SCIENCE, INC. 510(k) NO: K052161(SPECIAL)
ATTN: KENNETH F OLSON PHONE NO : 952-939-2912
1900 MAIN ST., SUITE 700 SE DECISION MADE: 21-OCT-05
IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALARIS SYSTEM PC UNIT, MODEL 8001
CARDINAL HEALTH, ALARIS PRODUCTS 510(k) NO: K051641(TRADITIONAL)
ATTN: STACY L LEWIS PHONE NO : 858-458-7830
10221 WATERIDGE CIRCLE SE DECISION MADE: 20-OCT-05
SAN DIEGO, CA 92121-2772 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODE
CARDIONET, INC 510(k) NO: K052240(ABBREVIATED)
ATTN: JACK GAIKWAD PHONE NO : 619-243-7527
1010 2ND AVE., SUITE 700 SE DECISION MADE: 19-OCT-05
SAN DIEGO, CA 92101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AOC BONE WAX OSTENE, OSTEOTENE AND CERETENE
CEREMED, INC. 510(k) NO: K052528(SPECIAL)
ATTN: TADEUSZ WELLISZ PHONE NO : 310-815-2125
3643 LENAWEE AVE. SE DECISION MADE: 11-OCT-05
LOS ANGELES, CA 90016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGICAL FACE MASK
CHINA SURGICAL DRESSINGS CENTER CO510(k) NO: K050689(TRADITIONAL)
ATTN: MICHAEL F. L CHANG PHONE NO : 886 227 033798
4 F. 232 JEN AI RD., SEC. 4 SE DECISION MADE: 26-OCT-05
TAIPEI, TAIWAN, CHINA (TAIWAN) 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700
CHRONO-LOG CORP. 510(k) NO: K050265(TRADITIONAL)
ATTN: NICHOLAS J VERIABO PHONE NO : 610-853-1130
2 WEST PARK RD. SE DECISION MADE: 14-OCT-05
HAVERTOWN, PA 19083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLOOD PRESSURE METER, MODEL CH-432
CITIZEN WATCH CO., LTD. 510(k) NO: K052046(SPECIAL)
ATTN: JOSEPH EDMONDSON PHONE NO : 202-672-5354
3000 K STREET, N.W., SUITE 500 SE DECISION MADE: 19-OCT-05
WASHINGTON, DC 20007 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: GII SPINAL FIXATION SYSTEM
CO-LIGNE AG 510(k) NO: K051089(TRADITIONAL)
ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640
200 GREGORY LANE, SUITE C-100 SE DECISION MADE: 26-OCT-05
PLEASANT HILL, CA 94523-3389 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CADMAN INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET, MODELS
CODMAN & SHURTLEFF, INC. 510(k) NO: K052449(TRADITIONAL)
ATTN: JOAN Q BARTLE PHONE NO : 508-880-8100
325 PARAMOUNT DR. SE DECISION MADE: 17-OCT-05
RAYNHAM, MA 02767-0350 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: COLLAGEN BONE HEALING PROTECTIVE SHEET
COLLAGEN MATRIX, INC. 510(k) NO: K052041(TRADITIONAL)
ATTN: PEGGY HANSEN PHONE NO : 201-405-1477
509 COMMERCE ST. SE DECISION MADE: 25-OCT-05
FRANKLIN LAKES,, NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HBA1C LINEARITY SET
CONE BIOPRODUCTS 510(k) NO: K052010(TRADITIONAL)
ATTN: WILLIAM CONE PHONE NO : 830-379-0197
1008 N. RIVER ST. SE DECISION MADE: 04-OCT-05
SEGUIN, TX 78155 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRACLEAN HANDCONTROLLED SUCTION COAGULATOR, MODEL 130182, 1301
CONMED CORPORATION 510(k) NO: K052104(TRADITIONAL)
ATTN: PAMELA VETTER PHONE NO : 303-699-7600
14603 E. FREMONT AVE. SE DECISION MADE: 21-OCT-05
CENTENNIAL, CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEM
CONMED INTEGRATED SYSTEMS (CMIS) 510(k) NO: K052740(SPECIAL)
ATTN: C. JEFF LIPPS PHONE NO : 503-614-1106
1815 NW 169TH PLACE SE DECISION MADE: 17-OCT-05
SUITE 4020 510(k) SUMMARY AVAILABLE FROM FDA
BEAVERTON, OR 97006
DEVICE: COOK IRELAND ECHOBRUSH
COOK IRELAND LTD 510(k) NO: K052279(TRADITIONAL)
ATTN: EMMETT DEVEREUX PHONE NO : 353 61 334440
O'HALLORAN ROAD SE DECISION MADE: 11-OCT-05
NATIONAL TECHNOLOGICAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
LIMERICK, IRELAND
DEVICE: MULTIPLE RESIN TOOTH BONDING AGENT
COSMEDENT, INC. 510(k) NO: K052501(TRADITIONAL)
ATTN: JAMES L SANDRIK PHONE NO : 312-644-9395
401 NORTH MICHIGAN AVE. SE DECISION MADE: 21-OCT-05
SUITE 2500 510(k) SUMMARY AVAILABLE FROM FDA
CHICAGO, IL 60611
DEVICE: QUICKSMILE
COSMETIC DENTAL MATERIALS INC 510(k) NO: K052040(TRADITIONAL)
ATTN: ROBERT BOWERS PHONE NO : 541-928-4444
812 WATER ST. N.E. SE DECISION MADE: 18-OCT-05
ALBANY, OR 97321 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VCS, MODEL S4T
CYCLING AND HEALTH TECH. INDUSTRY 510(k) NO: K052558(TRADITIONAL)
ATTN: CHANG W LAN PHONE NO : 886 423 501100
NO. 17, 37 RD., SE DECISION MADE: 27-OCT-05
TAICHUNG INDUSTRY PARK 510(k) SUMMARY AVAILABLE FROM FDA
TAICHUNG, CHINA (TAIWAN) 407
DEVICE: SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS
DADE BEHRING, INC. 510(k) NO: K052346(TRADITIONAL)
ATTN: ROBERT EUSEBIO PHONE NO : 916-374-3183
2040 ENTERPRISE BLVD. SE DECISION MADE: 26-OCT-05
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FRAGMENT SPECIFIC FIXATOR
DAVID J. SLUTSKY MD 510(k) NO: K052498(TRADITIONAL)
ATTN: DAVID J SLUTSKY PHONE NO : 310-792-1809
3475 TORRANCE BLVD., SUITE F SE DECISION MADE: 17-OCT-05
TORRANCE, CA 90503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLEURX PLEURAL CATHETER KIT, MODEL 50-7000
DENVER BIOMEDICAL, INC. 510(k) NO: K052436(SPECIAL)
ATTN: JEFF HILL PHONE NO : 303-279-7500
14998 WEST 6TH AVE., BLDG.E700 SE DECISION MADE: 06-OCT-05
GOLDEN, CO 80401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROTATOR CUFF QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE)
DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K052630(SPECIAL)
ATTN: DENISE LUCIANO PHONE NO : 781-251-2794
249 VANDERBILT AVE. SE DECISION MADE: 17-OCT-05
NORWOOD, MA 02062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUPER QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE)
DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K052631(SPECIAL)
ATTN: DENISE LUCIANO PHONE NO : 781-251-2794
249 VANDERBILT AVE. SE DECISION MADE: 21-OCT-05
NORWOOD, MA 02062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PINNACLE CONSTRAINED ACETABULAR LINERS
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K052079(TRADITIONAL)
ATTN: KELI K HANKEE PHONE NO : 574-372-7742
700 ORTHOPAEDIC DR. SE DECISION MADE: 21-OCT-05
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: DEPUY CAS HIP INSTRUMENTATION
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K052178(TRADITIONAL)
ATTN: RANDA FRANKLIN PHONE NO : 574-371-4906
700 ORTHOPAEDIC DR. SE DECISION MADE: 21-OCT-05
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: DEPUY GLOBAL SHOULDER CROSSLINK GLENOID
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K052472(SPECIAL)
ATTN: NATALIE HECK PHONE NO : 574-372-7469
700 ORTHOPAEDIC DR. SE DECISION MADE: 06-OCT-05
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: HYBRID ANTERIOR CERVICAL PLATE SYSTEM
DEPUY SPINE, INC. 510(k) NO: K052552(SPECIAL)
ATTN: LIZ LAVELLE PHONE NO : 508-828-2852
325 PARAMOUNT DR. SE DECISION MADE: 13-OCT-05
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONCORDE VBR SPINAL SYSTEM
DEPUY SPINE, INC. 510(k) NO: K052746(SPECIAL)
ATTN: LISA GILMAN PHONE NO : 508-880-8287
325 PARAMOUNT DR. SE DECISION MADE: 21-OCT-05
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: D732 MICRO 27 PH.I.S.I.O. ADULT ARTERIAL FILTER
DIDECO S.R.L. 510(k) NO: K052717(SPECIAL)
ATTN: BARRY SALL PHONE NO : 781-434-4742
200 WEST STREET SE DECISION MADE: 20-OCT-05
WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM
DIGIRAD CORP. 510(k) NO: K052430(SPECIAL)
ATTN: JOEL TUCKEY PHONE NO : 858-726-1600
13950 STOWE DRIVE SE DECISION MADE: 04-OCT-05
POWAY, CA 92064-8803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WRIST FUSION PLATE
DVO EXTREMITY SOLUTIONS, LLC 510(k) NO: K052754(TRADITIONAL)
ATTN: DINA L WEISSMAN PHONE NO : 203-287-0485
P.O. BOX 205 SE DECISION MADE: 27-OCT-05
DERBY, CT 06418 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYNATRON DX2 TRACTION UNIT
DYNATRONICS CORP. 510(k) NO: K051680(TRADITIONAL)
ATTN: RON HATCH PHONE NO : 801-568-7000
7030 PARK CENTRE DR. SE DECISION MADE: 11-OCT-05
SALT LAKE CITY, UT 84121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMG CTA01-XXX SERIES PURO OXYGEN CONCENTRATOR
EMG TECHNOLOGY CO., LTD. 510(k) NO: K043520(ABBREVIATED)
ATTN: LEONARD FRIER PHONE NO : 410-354-3300
914 WEST PATAPSCO AVE. SE DECISION MADE: 21-OCT-05
BALTIMORE, MD 21230 510(k) STATEMENT
DEVICE: CARE FECAL OCCULT BLOOD TEST, MODEL KT313
EPITOPE DIAGNOSTICS, INC. 510(k) NO: K051806(TRADITIONAL)
ATTN: PING GAO PHONE NO : 858-693-7877
7955 DUNBROOK RD., SUITE B SE DECISION MADE: 03-OCT-05
SAN DIEGO, CA 92126 510(k) STATEMENT
DEVICE: LEADCARE II BLOOD LEAD TESTING SYSTEM
ESA BIOSCIENCES INC. 510(k) NO: K052549(SPECIAL)
ATTN: HAROLD ASP PHONE NO : 978-250-7106
22 ALPHA RD. SE DECISION MADE: 06-OCT-05
CHELMSFORD, MA 01824-4171 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MYLAB30, 50 AND 70 SYSTEMS UPGRADE, MODELS 7300, 7350, 6150
ESAOTE S.P.A. 510(k) NO: K052805(TRADITIONAL)
ATTN: CARRI GRAHAM PHONE NO : 317-849-1916
7992 CASTLEWAY DRIVE SE DECISION MADE: 17-OCT-05
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIOLINE AR 600, AR 1200, AR 2100
ET MEDICAL DEVICES SPA 510(k) NO: K051534(SPECIAL)
ATTN: ATTILIO CASTELLI PHONE NO : 390 463 850125
VIA DE ZINIS 6 SE DECISION MADE: 05-OCT-05
CAVARENO, ITALY 38011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSCOPE MULTI-CLIP APPLIER, MODELS IN22321, IN23321
ETHICON ENDO-SURGERY, INC. 510(k) NO: K051950(TRADITIONAL)
ATTN: KIMBERLY SHOEMAKER PHONE NO : 513-337-8123
4545 CREEK RD. SE DECISION MADE: 07-OCT-05
CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ETIAM STAR PACS COMPONENTS
ETIAM, S.A. 510(k) NO: K052358(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 940-300-8601
1600 MANCHESTER WAY SE DECISION MADE: 05-OCT-05
CORINTH, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059
EXCEL TECH. LTD. 510(k) NO: K052112(SPECIAL)
ATTN: NICOLE LANDREVILLE PHONE NO : 905 829 5300X388
2568 BRISTOL CIRCLE SE DECISION MADE: 28-OCT-05
OAKVILLE, ONTARIO, CANADA L6H 5S1510(k) STATEMENT
DEVICE: EXEL SECURE TOUCH II SAFETY SYRINGE
EXELINT INTL. CO. 510(k) NO: K052103(TRADITIONAL)
ATTN: ARMAND HAMID PHONE NO : 310-649-0707
5840 WEST CENTINELA AVE. SE DECISION MADE: 19-OCT-05
LOS ANGELES, CA 90045 510(k) STATEMENT
DEVICE: INFRARED THERMOMETER, FDIR-V1
FAMIDOC TECHNOLOGY CO., LTD 510(k) NO: K052849(TRADITIONAL)
ATTN: MR. STEELJIN PHONE NO : +86 755 83412736
3RD FLOOR, EAST BLOCK 4 SE DECISION MADE: 26-OCT-05
CHEGONGMIAO ANHUA INDUST. ZONE 510(k) SUMMARY AVAILABLE FROM FDA
SCHENZHEN, GUANGDONG, CHINA THIRD PARTY REVIEW
DEVICE: EXPANSE VERTEBRAL BODY REPLACEMENT DEVICE
FLEXUSPINE, INC. 510(k) NO: K050997(TRADITIONAL)
ATTN: COREY HARBOLD PHONE NO : 903-445-9602
120 W. FIFTH STREET, SUITE 200 SE DECISION MADE: 07-OCT-05
TYLER, TX 75701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VP SHEATH
FLOWCARDIA, INC. 510(k) NO: K051580(TRADITIONAL)
ATTN: RICHARD SPANO PHONE NO : 408-617-0352
745 N. PASTORIA AVE. SE DECISION MADE: 31-OCT-05
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARCHITECT CA 19-9XR ASSAY
FUJIREBIO DIAGNOSTICS, INC. 510(k) NO: K052000(TRADITIONAL)
ATTN: DIANA L WOLANIUK PHONE NO : 610-240-3917
201 GREAT VALLEY PKWY. SE DECISION MADE: 25-OCT-05
MALVERN, PA 19355-1307 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: G-COAT
GC AMERICA, INC. 510(k) NO: K052462(TRADITIONAL)
ATTN: TERRY L JORITZ-LYONS PHONE NO : 708-926-3105
3737 WEST 127TH ST. SE DECISION MADE: 20-OCT-05
ALSIP, IL 60803 510(k) STATEMENT
DEVICE: DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSO
GE HEALTHCARE 510(k) NO: K052582(SPECIAL)
ATTN: JOEL KENT PHONE NO : 781-449-8685
86 PILGRIM ROAD SE DECISION MADE: 14-OCT-05
NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, E-NSAT
GE HEALTHCARE 510(k) NO: K052755(SPECIAL)
ATTN: JOEL KENT PHONE NO : 781-449-8685
86 PILGRIM ROAD SE DECISION MADE: 13-OCT-05
NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STARSPEED SERIES CT SCANNER SYSTEMS
GE HEALTHCARE 510(k) NO: K052855(TRADITIONAL)
ATTN: LEKSHMI NAIR PHONE NO : 262-312-7415
3000 N. GRANDVIEW BLVD W 1140 SE DECISION MADE: 28-OCT-05
WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: LUNAR IDXA
GE MEDICAL SYSTEMS ULTRASOUND AND 510(k) NO: K052581(SPECIAL)
ATTN: JAMES P RASKOB PHONE NO : 608-826-7425
726 HEARTLAND TRAIL SE DECISION MADE: 20-OCT-05
MADISON, WI 53717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MED FLASH II INTENSE PULSED LIGHT SYSTEM.
GENERAL PROJECT S.R.L. 510(k) NO: K051508(TRADITIONAL)
ATTN: MAUREEN O'CONNELL PHONE NO : 978-207-1245
5 TIMBER LANE SE DECISION MADE: 05-OCT-05
NORTH READING, MA 01864 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIMSTICK URINE REAGENT STRIPS
GERMAINE LABORATORIES, INC. 510(k) NO: K051727(TRADITIONAL)
ATTN: MARTIN O'CONNOR PHONE NO : 210-692-4192
4139 GARDENDALE CENTER, SE DECISION MADE: 26-OCT-05
SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA
SAN ANTONIO, TX 78229
DEVICE: GLOBAL RESURFACING UNICOMPARTMENTAL KNEE SYSTEM
GLOBAL ORTHOPAEDIC TECHNOLOGY, USA510(k) NO: K051721(TRADITIONAL)
ATTN: CARL KNOBLOCH PHONE NO : 407-977-8609
5349 RED LEAF COURT SE DECISION MADE: 26-OCT-05
OVIEDO, FL 32765-5018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GYRUS PLASMACISION AND PLASMABLEND ELECTRODES
GYRUS MEDICAL, INC. 510(k) NO: K050460(TRADITIONAL)
ATTN: MARK A JENSON PHONE NO : 763-416-3005
6655 WEDGWOOD ROAD, SUITE 160 SE DECISION MADE: 25-OCT-05
MAPLE GROVE, MN 55311-3602 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTSUCTION HARMONY DEVICE
HAEMONETICS CORP. 510(k) NO: K052626(TRADITIONAL)
ATTN: GABRIEL J MURACA PHONE NO : 781-356-9553
400 WOOD ROAD SE DECISION MADE: 05-OCT-05
BRAINTREE, MA 02184-9114 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PERIPRO PATCH
HANCOCK/JAFFE LABORATORIES 510(k) NO: K052416(TRADITIONAL)
ATTN: SUE MONTOYA PHONE NO : 949-261-2900
2807 MCGAW AVE. SE DECISION MADE: 25-OCT-05
IRVINE, CA 92614 510(k) STATEMENT
DEVICE: SHOULDER NAIL PLATE
HAND INNOVATIONS, LLC. 510(k) NO: K052294(TRADITIONAL)
ATTN: ERNESTO HERNANDEZ PHONE NO : 305-270-6899
8905 SW 87TH AVENUE SE DECISION MADE: 21-OCT-05
SUITE 220 510(k) SUMMARY AVAILABLE FROM FDA
MIAMI, FL 33176
DEVICE: HERACERAM ZIRKONIA
HERAEUS KULZER, INC. 510(k) NO: K052543(TRADITIONAL)
ATTN: CHERYL V ZIMMERMAN PHONE NO : 574-299-6662
4315 SOUTH LAFAYETTE BLVD. SE DECISION MADE: 25-OCT-05
SOUTH BEND, IN 46614-2517 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVON PATELLO-FEMORAL JOINT PROSTHESIS
HOWMEDICA OSTEONICS CORP 510(k) NO: K051948(TRADITIONAL)
ATTN: VIVIAN KELLY PHONE NO : 201-831-5581
325 CORPORATE DR. SE DECISION MADE: 21-OCT-05
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCORPIO KNEE SYSTEM TIBIAL INSERTS AND PATELLAR COMPONENTS
HOWMEDICA OSTEONICS CORP 510(k) NO: K051977(TRADITIONAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-831-5718
325 CORPORATE DR. SE DECISION MADE: 12-OCT-05
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V40 BIOLOX DELTA CERAMIC FEMORAL HEADS
HOWMEDICA OSTEONICS CORP 510(k) NO: K052718(SPECIAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-831-5718
325 CORPORATE DR. SE DECISION MADE: 27-OCT-05
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460002
HYPOGUARD USA, INC. 510(k) NO: K051514(TRADITIONAL)
ATTN: BRUCE A MACFARLANE PHONE NO : 952-646-3188
5182 WEST 76TH ST. SE DECISION MADE: 04-OCT-05
MINNEAPOLIS, MN 55439 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLECRANONPLATE WITH ANGULAR STABILITY
I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTE510(k) NO: K052368(TRADITIONAL)
ATTN: AL LIPPINCOTT PHONE NO : 952-492-5858
3150 E. 200TH ST. SE DECISION MADE: 17-OCT-05
PRIOR LAKE, MN 55372 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRICAT RIA (ADRENALIN/NORADRENALIN/DOPAMINE); KATCOMBI RIA (ADRE
IBL GMBH 510(k) NO: K051969(TRADITIONAL)
ATTN: GARY LEHNUS PHONE NO : 570-620-0198
150 CHERRY LANE RD. SE DECISION MADE: 03-OCT-05
EAST STROUDSBURG, PA 18301 510(k) STATEMENT
DEVICE: IMMUNALYSIS METHAMPHETAMINE ELISA FOR ORAL FLUIDS
IMMUNALYSIS CORPORATION 510(k) NO: K051577(TRADITIONAL)
ATTN: MICHAEL VINCENT PHONE NO : 909-482-0840
829 TOWNE CENTER DR. SE DECISION MADE: 04-OCT-05
POMONA, CA 91767 510(k) STATEMENT
DEVICE: IMMUNALYSIS AMPHETAMINE ELISA FOR ORAL FLUIDS
IMMUNALYSIS CORPORATION 510(k) NO: K051579(TRADITIONAL)
ATTN: MICHAEL VINCENT PHONE NO : 909-482-0840
829 TOWNE CENTER DR. SE DECISION MADE: 21-OCT-05
POMONA, CA 91767 510(k) STATEMENT
DEVICE: IMMUNALYSIS OPIATES ELISA FOR ORAL FLUIDS
IMMUNALYSIS CORPORATION 510(k) NO: K051626(TRADITIONAL)
ATTN: MICHAEL VINCENT PHONE NO : 909-482-0840
829 TOWNE CENTER DR. SE DECISION MADE: 13-OCT-05
POMONA, CA 91767 510(k) STATEMENT
DEVICE: UNI-VENT MODEL 73X
IMPACT INSTRUMENTATION, INC. 510(k) NO: K051476(TRADITIONAL)
ATTN: LESLIE H SHERMAN PHONE NO : 973-882-1212
27 FAIRFIELD PL. SE DECISION MADE: 28-OCT-05
P.O. BOX 508 510(k) STATEMENT
WEST CALDWELL, NJ 07006-0508
DEVICE: MODIFICATION TO 3I PATIENT-SPECIFIC DENTAL ABUTMENTS AND OVERDEN
IMPLANT INNOVATIONS, INC. 510(k) NO: K052648(SPECIAL)
ATTN: JIM BANIC PHONE NO : 561-776-6932
4555 RIVERSIDE DR. SE DECISION MADE: 20-OCT-05
PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IN6 SAFETY SYRINGE, MODEL 3ML
IN6 INCUVESTOR INC. 510(k) NO: K051800(ABBREVIATED)
ATTN: JENNIFER REICH PHONE NO : 928-773-9488
3892 SOUTH AMERICA WEST TRAIL SE DECISION MADE: 21-OCT-05
FLAGGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REFORMAT GATEWAY
INFINITT CO., LTD. 510(k) NO: K052284(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 904-300-8601
1600 MANCHESTER WAY SE DECISION MADE: 17-OCT-05
CORINTH, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IISIS, VERSION 1.0
INNOVISION MEDICAL TECHNOLOGIES, L510(k) NO: K052244(TRADITIONAL)
ATTN: PATRICIA L ANDREWS PHONE NO : 410-694-9450
1302 CONCOURSE DRIVE SE DECISION MADE: 13-OCT-05
SUITE 302 510(k) SUMMARY AVAILABLE FROM FDA
LINTHICUM, MD 21090
DEVICE: OOCYTE RETRIEVAL NEEDLE SET, MODELS 917-IH AND 917-SH
INNTEC, INC. 510(k) NO: K051742(ABBREVIATED)
ATTN: GARY SYRING PHONE NO : 608-877-2635
800 LEVANGER LANE SE DECISION MADE: 07-OCT-05
STOUGHTON, WI 53589 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTA LITE GLIADIN IGG II
INOVA DIAGNOSTICS, INC. 510(k) NO: K052142(TRADITIONAL)
ATTN: BRYS C MYERS PHONE NO : 858-586-9900
9900 OLD GROVE RD. SE DECISION MADE: 04-OCT-05
SAN DIEGO, CA 92131-1638 510(k) STATEMENT
DEVICE: QUANTA LITE GLIADIN IGA II
INOVA DIAGNOSTICS, INC. 510(k) NO: K052143(TRADITIONAL)
ATTN: BRYS C MYERS PHONE NO : 858-586-9900
9900 OLD GROVE RD. SE DECISION MADE: 04-OCT-05
SAN DIEGO, CA 92131-1638 510(k) STATEMENT
DEVICE: QUANTA LITE M2 EP (MIT3) ELISA
INOVA DIAGNOSTICS, INC. 510(k) NO: K052262(TRADITIONAL)
ATTN: BRYS C MYERS PHONE NO : 858-586-9900
9900 OLD GROVE RD. SE DECISION MADE: 27-OCT-05
SAN DIEGO, CA 92131-1638 510(k) STATEMENT
DEVICE: GEM PREMIER 3000
INSTRUMENTATION LABORATORY CO. 510(k) NO: K052121(SPECIAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
113 HARTWELL AVE. SE DECISION MADE: 21-OCT-05
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: YK9000 SERIES MANUAL WHEELCHAIR
INTCO METAL PRODUCTS (ZHENJIANG) C510(k) NO: K052468(TRADITIONAL)
ATTN: JOHN ZHAO PHONE NO : 909-548-4828
12390 EAST END AVENUE SE DECISION MADE: 05-OCT-05
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CX 250 C PLUS WITH GAMMAXP SOFTWARE, MODEL 0121 0000
INTER MEDICAL MEDIZINTECHNIK GMBH 510(k) NO: K052473(TRADITIONAL)
ATTN: HANS GUENTER OSIEK PHONE NO : 004 957 41235900
DAIMLERSTRASSE 34-36 SE DECISION MADE: 28-OCT-05
LUEBBECKE, GERMANY D-32312 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MILO DENTAL IMPLANT SYSTEM
INTRA-LOCK INTERNATIONAL 510(k) NO: K050970(TRADITIONAL)
ATTN: JEFFREY SAKOFF PHONE NO : 561-447-8282
1200 NORTH FEDERAL HWY. SE DECISION MADE: 14-OCT-05
SUITE 209 510(k) SUMMARY AVAILABLE FROM FDA
BOCA RATON, FL 33432
DEVICE: SUREFLOW SAFETY INFUSION DEVICE
INTRASAFE MEDICAL, LLC 510(k) NO: K051943(TRADITIONAL)
ATTN: SHEPARD G BENTLEY PHONE NO : 949-365-5790
28202 CABOT ROAD, SUITE 300 SE DECISION MADE: 04-OCT-05
LAGUNA NIGUEL, CA 92677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEUROVASCULAR ARRAY COIL, MODEL NVA-127-16-A
INVIVO CORP. 510(k) NO: K052497(SPECIAL)
ATTN: TOM SCHUBERT PHONE NO : 262-524-1402
N27 W23676 PAUL ROAD SE DECISION MADE: 12-OCT-05
PEWAUKEE, WI 53072 510(k) STATEMENT
DEVICE: IRRADIA MID - LASER (S3)
IRRADIA AB 510(k) NO: K051548(TRADITIONAL)
ATTN: THEO RUSSO-LARSSON PHONE NO : 949-250-1160
20101 SW BIRCH ST. #272 SE DECISION MADE: 24-OCT-05
NEWPORT BEACH, CA 92660 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 1125 XSB XENON FIBER-OPTIC LIGHT SOURCE
ISOLUX LLC 510(k) NO: K052979(TRADITIONAL)
ATTN: NILCOLAOS ANDREOULAKIS PHONE NO : 239-514-7475
1045 COLLIER CENTER WAY SE DECISION MADE: 31-OCT-05
SUITE #6 510(k) SUMMARY AVAILABLE FROM FDA
NAPLES, FL 34110-8444 THIRD PARTY REVIEW
DEVICE: IPS E.MAX CAD/IPS E.MAX ZIRCAD
IVOCLAR VIVADENT, INC. 510(k) NO: K051705(TRADITIONAL)
ATTN: DONNA MARIE HARTNETT PHONE NO : 716-691-0010
175 PINEVIEW DR. SE DECISION MADE: 14-OCT-05
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: AJEX 9015/135H PORTABLE X-RAY
JPI AMERICA, INC. 510(k) NO: K052341(TRADITIONAL)
ATTN: ABE ELGOHARY PHONE NO : 631-454-0090
141 CENTRAL AVE., SUITE A SE DECISION MADE: 07-OCT-05
FARMINGDALE, NY 11735-6903 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TECTONIC CERVICAL PLATE SYSTEM
K2M, LLC 510(k) NO: K051531(TRADITIONAL)
ATTN: RICH WOODS PHONE NO : 703-777-3155
751 MILLER DR.,S.E., SUITE F1 SE DECISION MADE: 17-OCT-05
LEESBURG, VA 20175 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAGNODENT
KAVO AMERICA 510(k) NO: K051909(TRADITIONAL)
ATTN: DENIEL KAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 21-OCT-05
DEER FIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH INSERTION STYLETS ACC
KENDALL 510(k) NO: K051584(SPECIAL)
ATTN: JAMES WELSH PHONE NO : 508-261-8532
15 HAMPSHIRE ST. SE DECISION MADE: 06-OCT-05
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KING I POWERED SCOOTER, MODEL CTL-11
KING I TECH CORPORATION 510(k) NO: K052673(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 17-OCT-05
HSIN-CHU CITY, CHINA (TAIWAN) 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AURA 70 WATT BIPOLAR ELECTROSURGICAL COAGULATORS, MODELS 28-2000
KIRWAN SURGICAL PRODUCTS, INC. 510(k) NO: K052203(TRADITIONAL)
ATTN: KEVIN P PRARIO PHONE NO : 781-834-6600
180 ENTERPRISE DR. SE DECISION MADE: 20-OCT-05
MARSHFIELD, MA 02050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KOWA VX-10
KOWA CO. LTD. 510(k) NO: K043213(TRADITIONAL)
ATTN: RICHARD N PHILLIPS PHONE NO : 301-272-3115
1801 ROCKVILLE PIKE SE DECISION MADE: 06-OCT-05
SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA
ROCKVILLE, MD 20852
DEVICE: TGO SPRAY
LABORATOIRES CARILENE S.A.S. 510(k) NO: K051812(TRADITIONAL)
ATTN: EMALEE MURPHY PHONE NO : 202-778-9428
1800 MASSACHUSETTS AVE., NW SE DECISION MADE: 21-OCT-05
WASHINGTON, DC 20036 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LANX VBR SYSTEM
LANX, LLC 510(k) NO: K052384(TRADITIONAL)
ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640
200 GREGORY LANE SE DECISION MADE: 07-OCT-05
SUITE C-100 510(k) SUMMARY AVAILABLE FROM FDA
PLEASANT HILL, CA 94523-3389
DEVICE: IBL CORTISOL LIA TEST KIT
LEHNUS & ASSOCIATES CONSULTING 510(k) NO: K052359(TRADITIONAL)
ATTN: GARY LEHNUS PHONE NO : 570-620-0198
150 CHERRY LANE RD. SE DECISION MADE: 03-OCT-05
EAST STROUDSBURG, PA 18301 510(k) STATEMENT
DEVICE: ALUMA SKIN RENEWAL SYSTEM
LUMENIS, INC. 510(k) NO: K051214(TRADITIONAL)
ATTN: CONNIE HOY PHONE NO : 408-764-3303
2400 CONDENSA ST. SE DECISION MADE: 24-OCT-05
SANTA CLARA, CA 95051-0901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MASTEL LASER CLEAN ROOM, MODEL EBS-100
MASTEL PRECISION SURGICAL INSTRUME510(k) NO: K043494(TRADITIONAL)
ATTN: MERLE GOERINGER PHONE NO : 605-341-4595
2843 SAMCO RD., SUITE A SE DECISION MADE: 04-OCT-05
RAPID CITY, SD 57702-9366 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODUS IMF SCREWS 2.0
MEDARTIS, INC. 510(k) NO: K052061(TRADITIONAL)
ATTN: FLOYD G LARSON PHONE NO : 858-792-1235
11234 EL CAMINO REAL, STE 200 SE DECISION MADE: 21-OCT-05
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INOGEN SATELLITE CONSERVER, MODEL SC-100
MEDICAL ELECTRONIC DEVICES, INC. 510(k) NO: K052563(TRADITIONAL)
ATTN: THOMAS WENZEL PHONE NO : 310-618-0306
2807 OREGON CT. #D6 SE DECISION MADE: 24-OCT-05
TORRANCE, CA 90503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATRILAZE MALLEABLE ABLATION PROBE
MEDICALCV, INC. 510(k) NO: K052495(SPECIAL)
ATTN: DENNY STEGER PHONE NO : 651-452-3000
9725 SOUTH ROBERT TRAIL SE DECISION MADE: 11-OCT-05
INVER GROVE HEIGHTS, MN 55077 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCUVIX XQ DIAGNOSTIC ULTRASOUND SYSTEM
MEDISON CO., LTD. 510(k) NO: K052911(TRADITIONAL)
ATTN: SHIM KYUNG-AM PHONE NO : 822 219 41281
997-10 DAECHI-DONG SE DECISION MADE: 31-OCT-05
KANGNANM-KU 510(k) SUMMARY AVAILABLE FROM FDA
SEOUL, REPUBLIC OF KOREA 135-280 THIRD PARTY REVIEW
DEVICE: MEDLINE IODOFORM PACKING STRIPS
MEDLINE INDUSTRIES, INC. 510(k) NO: K052720(TRADITIONAL)
ATTN: LARA N SIMMONS PHONE NO : 847-837-2759
ONE MEDLINE PL. SE DECISION MADE: 20-OCT-05
MUNDELEIN, IL 60060 510(k) STATEMENT
DEVICE: SURE-SCREEN AMPHETAMINE, BENZODIAZEPINE, COCAINE, METHAMPHETAMIN
MEDTOX DIAGNOSTICS, INC. 510(k) NO: K050394(TRADITIONAL)
ATTN: ALAN MORRIS PHONE NO : 336-226-6311
1238 ANTHONY RD. SE DECISION MADE: 25-OCT-05
BURLINGTON, NC 27215 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K052609(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
PYRAMID PLACE SE DECISION MADE: 21-OCT-05
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K052734(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
PYRAMID PLACE SE DECISION MADE: 21-OCT-05
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO:CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K052747(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
PYRAMID PLACE SE DECISION MADE: 28-OCT-05
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: VERTE-STACK SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K052261(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 07-OCT-05
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER
MENTOR CORPORATION 510(k) NO: K052440(SPECIAL)
ATTN: DONNA A CRAWFORD PHONE NO : 805-879-6304
201 MENTOR DRIVE SE DECISION MADE: 11-OCT-05
SANTA BARBARA, CA 93111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HDR IORT SHIELDED APPLICATOR
MICK RADIO-NUCLEAR INSTRUMENTS, IN510(k) NO: K052351(TRADITIONAL)
ATTN: FELIX MICK PHONE NO : 914-667-3999
521 HOMESTEAD AVE. SE DECISION MADE: 17-OCT-05
MOUNT VERNON, NY 10550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIM 3.5 (CIRCA)
MIMVISTA CORP. 510(k) NO: K052379(TRADITIONAL)
ATTN: PETER SIMMELINK PHONE NO : 216-896-9798
25200 CHAGRIN BLVD. SUITE 200 SE DECISION MADE: 31-OCT-05
CLEVELAND, OH 44122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINXRAY, MODEL HF100H+
MINXRAY, INC. 510(k) NO: K052721(SPECIAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
P.O. BOX 7007 SE DECISION MADE: 27-OCT-05
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MK-DENT LOW SPEED HANDPIECES AND ACCESSORIES INCLUDING SPARE PAR
MK-DENT GMBH 510(k) NO: K051872(TRADITIONAL)
ATTN: MARTINA GUNDEROTH PHONE NO : +49 871 4308378
EISENHUTWEG 15 SE DECISION MADE: 03-OCT-05
KUMHAUSEN-PREISENBERG, GERMANY 840510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEOBLUE COZY LED PHOTOTHERAPY SYSTEM
NATUS MEDICAL, INC. 510(k) NO: K051869(TRADITIONAL)
ATTN: LUANNE NG PHONE NO : 650-801-7306
1501 INDUSTRIAL RD. SE DECISION MADE: 07-OCT-05
SAN CARLOS, CA 94070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUAL SHOT - CONTRAST DELIVERY SYSTEM
NEMOTO KYORINDO CO., LTD. 510(k) NO: K052633(TRADITIONAL)
ATTN: TOSHIO KANETAKA PHONE NO : +81 358 428571
2-27-20 HONGO BUNKYO-KU SE DECISION MADE: 17-OCT-05
TOKYO, JAPAN 123-0033 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE (FDAD), VERSION 1.0
NEUROGNOSTICS, INC. 510(k) NO: K052571(SPECIAL)
ATTN: HRISHIKESH GADAGKAR PHONE NO : 414-727-7950
10437 INNOVATION DR. SE DECISION MADE: 17-OCT-05
SUITE 309 510(k) STATEMENT
MILWAUKEE, WI 53226
DEVICE: NEWGEL AND NEWGEL PLUS E
NEWMEDICAL TECHNOLOGY, INC. 510(k) NO: K041704(TRADITIONAL)
ATTN: HAITHAM MATLOUB PHONE NO : 847-412-1000
3324 COMMERCIAL AVENUE SE DECISION MADE: 17-OCT-05
NORTHBROOK, IL 60062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVASPINE CEMENT RESTRICTOR "NSCR"
NOVASPINE LLC 510(k) NO: K051607(TRADITIONAL)
ATTN: HAMID KHOSROWSHAHI PHONE NO : 914-909-6577
PO BOX 969 SE DECISION MADE: 07-OCT-05
ELMSFORD, NY 10523 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM
NUCLETRON CORPORATION 510(k) NO: K052361(SPECIAL)
ATTN: LISA DIMMICK PHONE NO : 410-312-4100
8671 ROBERT FULTON DR. SE DECISION MADE: 24-OCT-05
COLUMBIA, MD 21046-2133 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: NV CORMED SOLAS SPINAL SYSTEM
NV CORMED 510(k) NO: K051959(TRADITIONAL)
ATTN: CARL KNOBLOCH PHONE NO : 407-977-8609
5349 RED LEAF COURT SE DECISION MADE: 12-OCT-05
OVIEDO, FL 32756 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVIS EXERA 160A SYSTEM
OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K051645(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688
TWO CORPORATE CENTER DR. SE DECISION MADE: 13-OCT-05
MELVILLE, NY 11747-9058 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMRON NON-INVASIVE BLOOD PRESSURE MONITOR WITH AUGMENTATION INDE
OMRON HEALTHCARE, INC. 510(k) NO: K050233(TRADITIONAL)
ATTN: JIM LI, PH.D. PHONE NO : 847-247-5732
1200 LAKESIDE DRIVE SE DECISION MADE: 28-OCT-05
BANNOCKBURN, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAVE COMPOSITE BRACKET
ORTHO TECHNOLOGY, INC. 510(k) NO: K052714(TRADITIONAL)
ATTN: STEVE KLAMIC PHONE NO : 813-991-5896
17401 COMMERCE PARK BLVD. SE DECISION MADE: 26-OCT-05
TAMPA, FL 33647 510(k) STATEMENT
DEVICE: S-BONE HIP TOOL
ORTHOPEDIC SCIENCES, INC 510(k) NO: K052538(SPECIAL)
ATTN: JAMES K BRANNON PHONE NO : 562-799-5550
3020 OLD RANCH PARKWAY SE DECISION MADE: 07-OCT-05
SUITE 325 510(k) SUMMARY AVAILABLE FROM FDA
SEAL BEACH, CA 90740
DEVICE: VITAGEL SURGICAL HEMOSTAT SPRAY SET
ORTHOVITA, INC. 510(k) NO: K052173(TRADITIONAL)
ATTN: GINA M NAGVAJARA PHONE NO : 610-407-5251
45 GREAT VALLEY PKWY. SE DECISION MADE: 19-OCT-05
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OCT (OSTEOCHONDRAL TRANSPLANT) COMPREHENSIVE SYSTEM
OSTEOBIOLOGICS, INC. 510(k) NO: K051656(TRADITIONAL)
ATTN: GABRIELE G NIEDERAUER PHONE NO : 210-690-2131
UNIVERSITY BUSINESS PARK SE DECISION MADE: 25-OCT-05
12500 NETWORK, SUITE 112 510(k) SUMMARY AVAILABLE FROM FDA
SAN ANTONIO, TX 78249-3308
DEVICE: START FAMILY OF MANUAL WHEELCHAIRS (BASIC, PLUS, MULTI AND HEMI)
OTTO BOCK HEALTH CARE, LP 510(k) NO: K052681(TRADITIONAL)
ATTN: BOB CLARKE PHONE NO : 763-489-5105
2 CARLSON PARKWAY NORTH SE DECISION MADE: 06-OCT-05
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
MINNEAPOLIS, MN 55447-4467
DEVICE: PATHFORMER
PATH SCIENTIFIC, LLC 510(k) NO: K052770(TRADITIONAL)
ATTN: PATSY J TRISLER PHONE NO : 301-652-5344
5600 WISCONSIN AVE, #509 SE DECISION MADE: 31-OCT-05
CHEVY CHASE, MD 20815 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIMILE FLOW
PENTRON CLINICAL TECHNOLOGIES 510(k) NO: K052106(TRADITIONAL)
ATTN: GREG MOREAU PHONE NO : 203-265-7397
68-70 NORTH PLAINS INDUSTRIAL SE DECISION MADE: 31-OCT-05
ROAD 510(k) SUMMARY AVAILABLE FROM FDA
WALLINGFORD, CT 06492
DEVICE: AVANTE LED CURING UNIT, MODEL N44
PENTRON CLINICAL TECHNOLOGIES 510(k) NO: K052349(TRADITIONAL)
ATTN: GREG MOREAU PHONE NO : 203-265-7397
68-70 NORTH PLAINS INDUSTRIAL SE DECISION MADE: 21-OCT-05
ROAD 510(k) SUMMARY AVAILABLE FROM FDA
WALLINGFORD, CT 06492
DEVICE: PHILIPS HEARTSTART FR2+ AUTOMATED EXTERNAL DEFIBRILLATOR, MODELS
PHILIPS MEDICAL SYSTEMS 510(k) NO: K051632(TRADITIONAL)
ATTN: TAMARA YOUNT PHONE NO : 206-664-5290
2301 FIFTH AVE., SUITE 200 SE DECISION MADE: 05-OCT-05
SEATTLE, WA 98121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M3046B COMPACT PORTABLE PATIENT MONITORS
PHILIPS MEDICAL SYSTEMS 510(k) NO: K052707(SPECIAL)
ATTN: MICHAEL J DOYLE PHONE NO : 978-659-3198
3000 MINUTEMAN RD. SE DECISION MADE: 20-OCT-05
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEMINI RAPTOR
PHILIPS MEDICAL SYSTEMS(CLEVELAND)510(k) NO: K052640(TRADITIONAL)
ATTN: MELINDA NOVATNY PHONE NO : 440-483-4255
595 MINER RD. SE DECISION MADE: 07-OCT-05
CLEVELAND, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: N-DO ENDOINJECTOR NEEDLE, MODEL PH00961109 AND PH00961110
PHYSION, INC. 510(k) NO: K043383(TRADITIONAL)
ATTN: ERIC J NEMETH, ESQ. PHONE NO : 973-376-7700
51 JOHN F. KENNEDY PKWY. SE DECISION MADE: 27-OCT-05
SHORT HILLS, NJ 07078-5006 510(k) STATEMENT
DEVICE: ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AN
POINTE SCIENTIFIC, INC. 510(k) NO: K051646(TRADITIONAL)
ATTN: WILLIAM F WALTERS PHONE NO : 734-487-8310
5449 RESEARCH DRIVE SE DECISION MADE: 07-OCT-05
CANTON, MI 48188 510(k) STATEMENT
DEVICE: EQUATOR PLUS ACETABULAR CUP SYSTEM
PORTLAND ORTHOPAEDICS PTY. LTD. 510(k) NO: K051844(TRADITIONAL)
ATTN: ELAINE DUNCAN PHONE NO : 715-549-6035
PO BOX 560 SE DECISION MADE: 07-OCT-05
STILLWATER, MN 55082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROASIA, MODEL L3402
PROASIA LIMITED 510(k) NO: K052378(TRADITIONAL)
ATTN: JEFF CHANG PHONE NO : 886 4 22465396
16F-2, NO. 462 CHONG-DE ROAD SE DECISION MADE: 07-OCT-05
SEC. 2 510(k) SUMMARY AVAILABLE FROM FDA
BEITUN DISTRICT, TAICHUNG, CHINA (TAIWAN) 40653
DEVICE: PROASIA, MODEL L4501
PROASIA LIMITED 510(k) NO: K052486(TRADITIONAL)
ATTN: JEFF CHANG PHONE NO : 886 422 465396
16F-2, NO. 462 CHONG-DE ROAD SE DECISION MADE: 07-OCT-05
SEC. 2 510(k) SUMMARY AVAILABLE FROM FDA
BEITUN DISTRICT, TAICHUNG, CHINA (TAIWAN) 40653
DEVICE: PROMETAL HN86
PROMETAL TECHNOLOGIES 510(k) NO: K052463(TRADITIONAL)
ATTN: DONNA MARIE HARTNETT PHONE NO : 716-934-3395
67 MAIN STREET SE DECISION MADE: 14-OCT-05
SILVER CREEK, NY 14136 510(k) STATEMENT
DEVICE: FLEXISKIN POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE,
PT. MANDIRI INTI BUANA 510(k) NO: K051987(TRADITIONAL)
ATTN: SASITHARAN NAIR PHONE NO : 62 61 7944880
JALAN SEI BELUMAI SE DECISION MADE: 06-OCT-05
DESA DALU 10 A DUSUN 1 510(k) SUMMARY AVAILABLE FROM FDA
TANJUNG MORAWA, SUMUT, INDONESIA 20362
DEVICE: AUTOCHECK6+
RADIOMETER MEDICAL APS 510(k) NO: K051928(TRADITIONAL)
ATTN: LENE M MARNAES PHONE NO : 453 827 3374
AKANDEVEJ 21 SE DECISION MADE: 12-OCT-05
BRONSHOJ, DENMARK DK-2700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SELECTFLOW - INTRAVASCULAR ADMINISTRATION SET
RENASCENCE MEDICAL, INC. 510(k) NO: K052658(TRADITIONAL)
ATTN: DANIEL DYAR PHONE NO : 812-330-1129
2536 W. INDUSTRIAL DR., SE DECISION MADE: 12-OCT-05
SUITE 7 510(k) SUMMARY AVAILABLE FROM FDA
BLOOMINGTON, IN 47404 THIRD PARTY REVIEW
DEVICE: RESPCARE FACE MASK
RESPCARE INC. 510(k) NO: K052227(TRADITIONAL)
ATTN: FRANK PELC PHONE NO : 561-208-3778
6601 LYONS ROAD, SUITES B1-B4 SE DECISION MADE: 28-OCT-05
COCONUT CREEK, FL 33073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M-SERIES PRO CPAP SYTEM
RESPIRONICS, INC. 510(k) NO: K052110(SPECIAL)
ATTN: ZITA A YURKO PHONE NO : 724-387-4120
1001 MURRY RIDGE LN. SE DECISION MADE: 20-OCT-05
MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLEXIBLE VIDEO CYSTOSCOPE/CHOLEDOCHOSCOPE, MODELS 7308.061 AND 7
RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K051176(TRADITIONAL)
ATTN: ROBERT L CASARSA PHONE NO : 847-913-1113
353 CORPORATE WOODS PKWY. SE DECISION MADE: 05-OCT-05
VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYSAFE MICRO MODULAR FORCEPS AND SCISSORS SYSTEM
RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K051276(TRADITIONAL)
ATTN: ROBERT L CASARSA PHONE NO : 847-913-1113
353 CORPORATE WOODS PKWY. SE DECISION MADE: 28-OCT-05
VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISE COMPENSATOR
ROCHE DIAGNOSTICS 510(k) NO: K052193(TRADITIONAL)
ATTN: CORINA HARPER PHONE NO : 317-521-3831
9115 HAGUE ROAD SE DECISION MADE: 03-OCT-05
INDIANAPOLIS, IN 46256 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROCHE DIAGNOSTICS COBAS ELECSYS PROLACTIN II CALSET
ROCHE DIAGNOSTICS 510(k) NO: K052982(SPECIAL)
ATTN: RANDY JOHNSON PHONE NO : 317-521-3532
9115 HAGUE ROAD SE DECISION MADE: 28-OCT-05
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECSYS PRECICONTROL BONE
ROCHE DIAGNOSTICS CORP. 510(k) NO: K051543(TRADITIONAL)
ATTN: CORINA HAPER PHONE NO : 317-521-3831
9115 HAGUE RD. SE DECISION MADE: 17-OCT-05
P.O. BOX 50457 510(k) SUMMARY AVAILABLE FROM FDA
INDIANAPOLIS, IN 46250-0457
DEVICE: CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE
ROCKET MEDICAL PLC 510(k) NO: K052365(TRADITIONAL)
ATTN: TRACY CHARLTON PHONE NO : 44 191 4194488222
WEAR INDUSTRIAL ESTATE SE DECISION MADE: 17-OCT-05
WASHINGTON 510(k) SUMMARY AVAILABLE FROM FDA
TYNE AND WEAR, UNITED KINGDOM NE38 9BZ
DEVICE: WATER FILLED TEETHER
ROYAL INDUSTRIES (THAILAND) PUBLIC510(k) NO: K052105(TRADITIONAL)
ATTN: ANDREW SIMS PHONE NO : 662 810 4461
126, MOO 6 SETHAKIT 1, RD., SE DECISION MADE: 31-OCT-05
OMNOI, 510(k) SUMMARY AVAILABLE FROM FDA
KRATHUMBAN, THAILAND 74130
DEVICE: RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 31108
RUBICOR MEDICAL, INC. 510(k) NO: K052506(SPECIAL)
ATTN: ROBERT J CHIN PHONE NO : 650-593-5225
25 HARTFORD AVE. SE DECISION MADE: 06-OCT-05
SAN CAROLS, CA 94070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION),
SCANTIBODIES LABORATORY, INC. 510(k) NO: K051888(TRADITIONAL)
ATTN: MICHAEL NORDSTROM PHONE NO : 619-258-9300
9336 ABRAHAM WAY SE DECISION MADE: 18-OCT-05
SANTEE, CA 92071 510(k) STATEMENT
DEVICE: FUTURAPRESS LT, N AND HP, FUTURAJET, FUTURASELF, FUTURAGEN AND F
SCHUTZ-DENTAL GMBH 510(k) NO: K052073(TRADITIONAL)
ATTN: MICHAEL WIERZ PHONE NO : 49 600 3814367
DIESELSTRASSE 5-6 SE DECISION MADE: 26-OCT-05
ROSBACH, HESSEN, GERMANY D-61191 510(k) STATEMENT
DEVICE: REVENEER CERAMIC REPAIR SYSTEM
SCHUTZ-DENTAL GMBH 510(k) NO: K052189(TRADITIONAL)
ATTN: MICHAEL WIERZ PHONE NO : 496 003 814620
DIESELSTRASSE 5-6 SE DECISION MADE: 17-OCT-05
ROSBACH, HESSEN, GERMANY D-61191 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCIENT'X CEMENT RESTRICTOR
SCIENT'X 510(k) NO: K052367(TRADITIONAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD. SE DECISION MADE: 05-OCT-05
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIRTUAL MEDICAL SYSTEMS MODEL VT3000
SCIENTIFIC IMAGING, INC. 510(k) NO: K052904(TRADITIONAL)
ATTN: CHRIS JOHNSON PHONE NO : 770-926-3277
110 BASCOMB DRIVE SE DECISION MADE: 27-OCT-05
WOODSTOCK, GA 30189 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER
SECHRIST INDUSTRIES, INC. 510(k) NO: K052713(SPECIAL)
ATTN: GERG GODFREY PHONE NO : 714-579-8318
4225 EAST LA PALMA AVE. SE DECISION MADE: 28-OCT-05
ANAHEIM, CA 92807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTROSURGICAL GENERATOR SYSTEM, MODEL ES 3000
SENORX, INC. 510(k) NO: K052857(SPECIAL)
ATTN: AMY BOUCLY PHONE NO : 949-362-4800
11 COLUMBIA, SUITE A SE DECISION MADE: 21-OCT-05
ALISO VIEJO, CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENTINEL CLIN CHEM CAL
SENTINEL CH. SRL 510(k) NO: K051452(ABBREVIATED)
ATTN: DAVIDE SPADA PHONE NO : 39 02 3455141
5 VIA PRINCIPE EUGENIO SE DECISION MADE: 25-OCT-05
MILANO, ITALY 20155 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENTINEL CERULOPLASMIN
SENTINEL CH. SRL 510(k) NO: K051456(TRADITIONAL)
ATTN: DAVIDE SPADA PHONE NO : 39 02 3455141
5 VIA PRINCIPE EUGENIO SE DECISION MADE: 21-OCT-05
MILANO, ITALY 20155 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DAR-8000F
SHIMADZU MEDICAL SYSTEMS 510(k) NO: K052500(ABBREVIATED)
ATTN: RANDAL WALKER PHONE NO : 310-217-8855
20101 SOUTH VERMONT AVE. SE DECISION MADE: 17-OCT-05
TORRANCE, CA 90502-1328 510(k) STATEMENT
DEVICE: NON-STERILE POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, WITH VI
SIAM SEMPERMED CORP. LTD. 510(k) NO: K052890(ABBREVIATED)
ATTN: WILLIAM E HARRIS PHONE NO : 727-787-7250
13900 49TH STREET NORTH SE DECISION MADE: 31-OCT-05
CLEARWATER, FL 33762 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNGO MULTIMODALITY WORKPLACE (SYNGO MM WP)
SIEMENS AG, MEDICAL SOLUTIONS 510(k) NO: K052775(TRADITIONAL)
ATTN: SIEGLINDE WEST PHONE NO : 499 131 843144
HENKESTRASSE 127 SE DECISION MADE: 31-OCT-05
ERLANGEN, GERMANY 91052 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MAGNETOM SYSTEMS WITH SOFTWARE SYNGO MR 2006A
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K052164(TRADITIONAL)
ATTN: JUDITH CAMPBELL PHONE NO : 610-448-4918
51 VALLEY STREAM PKWY. SE DECISION MADE: 04-OCT-05
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FOURSIGHT VIEWTOOL IMAGE VIEWER
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K052895(TRADITIONAL)
ATTN: PATRICK J LYNCH PHONE NO : 425-557-1825
1230 SHOREBIRD WAY SE DECISION MADE: 27-OCT-05
P O BOX 7393 510(k) SUMMARY AVAILABLE FROM FDA
MOUNTAIN VIEW, CA 94039-7393 THIRD PARTY REVIEW
DEVICE: SMITH & NEPHEW CONTINUOUS LOOP FIXATION DEVICE
SMITH & NEPHEW, INC. 510(k) NO: K052652(TRADITIONAL)
ATTN: DEANA BOUSHELL PHONE NO : 508-337-4036
150 MINUTEMAN RD. SE DECISION MADE: 21-OCT-05
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANTHOLOGY HIP STEM
SMITH & NEPHEW, INC. 510(k) NO: K052792(SPECIAL)
ATTN: JANET AKIL PHONE NO : 901-399-5153
1450 BROOKS RD. SE DECISION MADE: 07-OCT-05
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SORING GMBH SONOCA LIPO
SORING GMBH MEDIZINTECHNIK 510(k) NO: K052183(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 940-300-8601
1600 MANCHESTER WAY SE DECISION MADE: 07-OCT-05
CORINTH, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLIRPATH TURBO PLUS EXCIMER LASER CATHETERS, MODELS 314-151, 314
SPECTRANETICS CORP. 510(k) NO: K052514(TRADITIONAL)
ATTN: NEIL BURRIS PHONE NO : 719-633-8333
96 TALAMINE CT. SE DECISION MADE: 19-OCT-05
COLORADO SPRINGS, CO 80907-5159 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROVEN REVISION MODULAR TIBIAL TRAY
STELKAST COMPANY 510(k) NO: K051976(TRADITIONAL)
ATTN: DONALD A STEVENS PHONE NO : 724-941-6368
200 HIDDEN VALLEY RD. SE DECISION MADE: 17-OCT-05
MCMURRAY, PA 15317 510(k) STATEMENT
DEVICE: STERITEC CONTAINER CORD - CI 135, STERITEC PROCESS INDICATOR LAB
STERITEC PRODUCTS, INC. 510(k) NO: K052516(ABBREVIATED)
ATTN: LINDA NELSON PHONE NO : 303-660-4201
599 TOPEKA WAY, SUITE 400 SE DECISION MADE: 03-OCT-05
CASTLE ROCK, CO 80109 510(k) STATEMENT
DEVICE: STOMA BONE SCREW
STORZ AM MARK GMBH 510(k) NO: K051871(TRADITIONAL)
ATTN: FRANZ MENEAN PHONE NO : 49 746 3995411
GRIESWEG 47 SE DECISION MADE: 27-OCT-05
MUEHLHEIM, GERMANY 78570 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER STILETTO ELECTROSURGICAL PROBE
STRYKER ENDOSCOPY 510(k) NO: K052141(TRADITIONAL)
ATTN: CRYSTAL ONG PHONE NO : 408-754-2491
5900 OPTICAL CT. SE DECISION MADE: 06-OCT-05
SAN JOSE, CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: XIA 4.5 SPINAL SYSTEM
STRYKER SPINE 510(k) NO: K052761(SPECIAL)
ATTN: SIMONA VOIC PHONE NO : 201-760-8145
2 PEARL COURT SE DECISION MADE: 11-OCT-05
ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SILGIMIX ALGINATE REPLACEMENT IMPRESSION MATERIAL
SULTAN CHEMISTS, INC. 510(k) NO: K052409(TRADITIONAL)
ATTN: CLARK SMITH PHONE NO : 201-871-1232
85 WEST FOREST AVE. SE DECISION MADE: 20-OCT-05
ENGLEWOOD, NJ 07631 510(k) STATEMENT
DEVICE: SYNTHES (USA) POROUS POLYETHYLENE IMPLANTS
SYNTHES (USA) 510(k) NO: K051879(TRADITIONAL)
ATTN: KATHY ANDERSON PHONE NO : 610-719-5860
1302 WRIGHTS LANE EAST SE DECISION MADE: 05-OCT-05
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES LCP PROXIMAL TIBIA PLATES LINE EXTENSION
SYNTHES (USA) 510(k) NO: K052390(TRADITIONAL)
ATTN: LISA BOYLE PHONE NO : 610-719-5860
1302 WRIGHTS LANE EAST SE DECISION MADE: 07-OCT-05
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES UNIVERSAL LOCKING TROCHANTER STABILIZATION PLATE (ULTSP)
SYNTHES (USA) 510(k) NO: K052677(TRADITIONAL)
ATTN: SHERI L MUSGNUNG PHONE NO : 610-719-5868
1302 WRIGHTS LANE EAST SE DECISION MADE: 12-OCT-05
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEH LOONG POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, W
TEH LOONG CORP. 510(k) NO: K052634(TRADITIONAL)
ATTN: CHIEN LIN PHONE NO : 773-327-2054
2631, N. MAGNOLIA STREET SE DECISION MADE: 11-OCT-05
CHICAGO, IL 60614 510(k) STATEMENT
DEVICE: NUZONE SYNGARD POWDER FREE POLYMER COATED POLYISOPRENE STERILE S
TERANG NUSA SDN BHD 510(k) NO: K051562(TRADITIONAL)
ATTN: CHIN-GUAN LOW PHONE NO : 60 9 7747171
1, JALAN 8, SE DECISION MADE: 20-OCT-05
PENGKALAN CHEPA 2 IND. ZONE 510(k) SUMMARY AVAILABLE FROM FDA
KOTA BHARU, KELANTAN, MALAYSIA 16100
DEVICE: DEUTSCH ANTI-BLOCKAGE WOUND DRAIN
THE CATHETER EXCHANGE, INC. 510(k) NO: K052286(TRADITIONAL)
ATTN: GEORGE P TEITELBAUM PHONE NO : 323-442-8948
16633 VENTURA BLVD. SE DECISION MADE: 21-OCT-05
SUITE 735 510(k) SUMMARY AVAILABLE FROM FDA
ENCINO, CA 91436
DEVICE: MODEL 672-BD, HOME UVB LIGHT SOURCE (JORDAN LIGHT); MODEL 2400,
THE RICHMOND LIGHT CO. 510(k) NO: K052660(TRADITIONAL)
ATTN: ALEX M CLARKE PHONE NO : 804-276-9559
2301 FALKIRK DR. SE DECISION MADE: 17-OCT-05
RICHMOND, VA 23236 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THERATEST EL-ANA PROFILES
THERATEST LABORATORIES, INC. 510(k) NO: K051066(TRADITIONAL)
ATTN: MARIUS TEDORESCU PHONE NO : 630-627-6069
1111 N. MAIN ST. SE DECISION MADE: 07-OCT-05
LOMBARD, IL 60148 510(k) STATEMENT
DEVICE: THERMAGE THERMACOOL SKIN MARKETING
THERMAGE, INC. 510(k) NO: K052778(TRADITIONAL)
ATTN: PAMELA M BUCKMAN PHONE NO : 510-259-7116
25881 INDUSTRIAL BLVD. SE DECISION MADE: 20-OCT-05
HAYWARD, CA 94545 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AQUAMANTYS PUMP GENERATOR SYSTEM
TISSUELINK MEDICAL, INC. 510(k) NO: K052859(SPECIAL)
ATTN: VICKI ANASTASI PHONE NO : 603-151-1515
ONE WASHINGTON CENTER SE DECISION MADE: 25-OCT-05
SUITE 400 510(k) SUMMARY AVAILABLE FROM FDA
DOVER, NH 03820
DEVICE: MODEL DFP-8000D/FPD DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL D
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K052884(TRADITIONAL)
ATTN: MICHAELA MAHL PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 26-OCT-05
P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92781-2068 THIRD PARTY REVIEW
DEVICE: 3.8MM CS FACET COMPRESSION DEVICE
TRIAGE MEDICAL, INC. 510(k) NO: K052043(TRADITIONAL)
ATTN: GAYLE HIROTA PHONE NO : 949-472-0006
13700 ALTON PKWY., SUITE 160 SE DECISION MADE: 17-OCT-05
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KENDALL SCD SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE THIGH), KENDA
TYCO HEALTHCARE/KENDALL 510(k) NO: K051805(TRADITIONAL)
ATTN: BRIDGET GARDNER PHONE NO : 508-261-6384
15 HAMPSHIRE STREET SE DECISION MADE: 13-OCT-05
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DSNARE, MODEL 00711087
UNITED STATES ENDOSCOPY GROUP, INC510(k) NO: K051637(TRADITIONAL)
ATTN: GRETCHEN Y COHEN PHONE NO : 440-639-4494
5976 HEISELY RD. SE DECISION MADE: 31-OCT-05
MENTOR, OH 44060 510(k) STATEMENT
DEVICE: URGENT PC NEUROMODULATION SYSTEM
UROPLASTY, INC. 510(k) NO: K052025(TRADITIONAL)
ATTN: MICHAEL MORRELL PHONE NO : 612-378-1180
2718 SUMMER ST. NE SE DECISION MADE: 17-OCT-05
MINNEAPOLIS, MN 55413-2820 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: I-STOP MID-URETHRAL SLING, MODELS IS-1000, IS-2000, IS-3000, IS-
UROPLASTY, INC. 510(k) NO: K052175(TRADITIONAL)
ATTN: MICHAEL MORRELL PHONE NO : 612-378-1180
2718 SUMMER ST. NE SE DECISION MADE: 17-OCT-05
MINNEAPOLIS, MN 55413-2820 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 1.5T 12 CHANNEL BODY ARRAY
USA INSTRUMENTS, INC. 510(k) NO: K052584(SPECIAL)
ATTN: ROBERT B SMITH PHONE NO : 330-562-1000
1515 DANNER DR. SE DECISION MADE: 07-OCT-05
AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3T HD BREAST ARRAY
USA INSTRUMENTS, INC. 510(k) NO: K052585(SPECIAL)
ATTN: DAVID BROWN PHONE NO : 330-562-1000
1515 DANNER DR. SE DECISION MADE: 04-OCT-05
AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 1.5T 16 CHANNEL BRAIN-SPINE ARRAY COIL
USA INSTRUMENTS, INC. 510(k) NO: K052621(SPECIAL)
ATTN: ROBERT B SMITH PHONE NO : 330-562-1000
1515 DANNER DR. SE DECISION MADE: 07-OCT-05
AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KIT
VERIDEX, LLC 510(k) NO: K052191(TRADITIONAL)
ATTN: DEBRA J RASMUSSEN PHONE NO : 908-791-2438
33 TECHNOLOGY DR. SE DECISION MADE: 27-OCT-05
WARREN, NJ 07059 510(k) STATEMENT
DEVICE: MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM
VERTEBRON, INC. 510(k) NO: K051815(SPECIAL)
ATTN: LUIS NESPRIDO PHONE NO : 203-380-9340
400 LONG BEACH BLVD. SE DECISION MADE: 17-OCT-05
STRATFORD, CT 06615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWERED PD-IO INTRAOSSEOUS INFUSION SYSTEM
VIDACARE CORPORATION 510(k) NO: K051992(TRADITIONAL)
ATTN: GRACE HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 20-OCT-05
IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VNUS RFS, MODEL RFS-6-XX (XX = 10, 12, 13, & 15); VNUS RFS FLEX,
VNUS MEDICAL TECHNOLOGIES, INC. 510(k) NO: K052003(TRADITIONAL)
ATTN: SAM NANAVATI PHONE NO : 408-250-8931
750 CHESAPEAKE DR. SE DECISION MADE: 11-OCT-05
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VYGON MICRO-ACCESS SAFETY INTRODUCER KIT
VYGON CORP. 510(k) NO: K051248(TRADITIONAL)
ATTN: COURTNEY SMITH PHONE NO : 610-539-9300
2495 GENERAL ARMISTEAD AVE SE DECISION MADE: 27-OCT-05
NORRISTOWN, PA 19403 510(k) STATEMENT
DEVICE: BURANE
WAVELIGHT LASER TECHNOLOGIE AG 510(k) NO: K052806(TRADITIONAL)
ATTN: ALEXANDER POPP PHONE NO : +49 913 16186121
AM WOLFSMANTEL 5 SE DECISION MADE: 17-OCT-05
ERLANGEN, GERMANY 91058 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: WIDE 5MP (MAMMO) LCD MONITOR SYSTEM
WIDE CORPORATION 510(k) NO: K052312(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 940-300-8601
1600 MANCHESTER WAY SE DECISION MADE: 07-OCT-05
CORINTH, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPIDER CERVICAL PLATING (SCP) SYSTEM
X-SPINE SYSTEMS, INC. 510(k) NO: K052292(TRADITIONAL)
ATTN: DAVID KIRSCHMAN PHONE NO : 800-903-0640
7026 CORPORATE WAY SE DECISION MADE: 21-OCT-05
# 212 510(k) SUMMARY AVAILABLE FROM FDA
CENTERVILLE, OH 45459-4288
DEVICE: LONGFEI LFY-I-5 OXYGEN CONCENTRATOR
ZHEJIANG LONGFEI INDUSTRIAL CO., L510(k) NO: K033405(TRADITIONAL)
ATTN: COCO WANG PHONE NO : 86 21 52661572
2288 CAOYANG ROAD SE DECISION MADE: 18-OCT-05
SHANGHAI, CHINA 200333 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIMMER DENTAL HEX-LOCK PREPARED ABUTMENT (STRAIGHT & ANGLED)
ZIMMER DENTAL INC. 510(k) NO: K052600(SPECIAL)
ATTN: ERIN MCVEY PHONE NO : 760-929-4300
1900 ASTON AVE. SE DECISION MADE: 13-OCT-05
CARLSBAD, CA 92008-7308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM WITH PATIENT CONTR
ZIMMER, INC. 510(k) NO: K052171(TRADITIONAL)
ATTN: CINDY J DICKEY PHONE NO : 330-364-9493
200 WEST OHIO AVENUE SE DECISION MADE: 13-OCT-05
P.O. BOX 10 510(k) SUMMARY AVAILABLE FROM FDA
DOVER, OH 44622-0010
TOTAL 510(k)s THIS PERIOD 245
TOTAL WITH SUMMARIES 203
TOTAL WITH STATEMENTS 42
Updated September 13, 2006
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