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U.S. Department of Health and Human Services

510(K) Premarket Notification

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510(K)
Number
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Decision
Date
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novabone-bioglass bone graft particulate U.S. BIOMATERIALS CORP. k000149 02/07/2000
surgical face mask - colors: white, yellow, pink, blue, and green TUCKER & ASSOCIATES k022256 04/26/2004
digipan / dpi TROPHY RADIOLOGIE k012514 12/21/2001
e.n.s.i. syringe TRI-JECT INTL. CORP. k000572 02/24/2000
sensititre 18-24 hours susceptibility plates TREK DIAGNOSTIC SYSTEMS, INC. k022775 09/25/2002
digital radiography system, model dfp-8000d TOSHIBA AMERICA MEDICAL SYSTEMS, INC. k013608 11/15/2001
ssa-770a, aplio ultrasound system TOSHIBA AMERICA MEDICAL SYSTEMS, INC. k013633 11/13/2001
hemofeel-ch, models ch-0.35l, ch-0.6l, ch-1.0l TORAY INDUSTRIES (AMERICA), INC. k994198 08/25/2000
tissuelink bipolar floating ball device TISSUELINK MEDICAL, INC. k020574 05/20/2002
permacol TISSUE SCIENCE LABORATORIES, PLC k013625 01/17/2002

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