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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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basic, models basic 1, basic 2, and basic 3 ATYS MEDICAL k012369 08/10/2001
bayer valproic acid assay for the acs:180 and advia centaur analyzers BAYER DIAGNOSTICS CORP. k013959 01/29/2002
bcs system DADE BEHRING, INC. k013114 11/09/2001
bd bifurcated needle, models 301754, 301755, 301756, 301757 BD k020523 03/20/2002
bd introsyte precision introducer; bd introsyte-n precision introducer; bd introsyte autoguard shielded introducer; bd i BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. k020834 06/12/2002
bdprobetec et ct/gc amplified dna assay BECTON DICKINSON & CO. k012351 09/18/2001
bicap coag bipolar laparoscopy probe, model 006908-910 ACMI CORPORATION k012018 07/16/2002
bioabsorbable interference screw megafix KARL STORZ ENDOSCOPY k013107 02/26/2002
biological sound monitor (bsm) sensor ANDROMED, INC. k021389 10/01/2002
bioscrew xtralok LINVATEC CORP. k013131 06/11/2002

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