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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Applicant
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510(K)
Number
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Decision
Date
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dynapulse 5200a pathway blood pressure monitoring system PULSE METRIC, INC. k013478 01/10/2002
biocheck human cardiac troponin-i immunoassay test kit BIOCHECK, INC. k013062 01/08/2002
gelclair concentrated oral gel SINCLAIR PHARMACEUTICALS, LTD. k013056 12/21/2001
spife 2000/3000 lipoprotein; model# 3340, 3341, 3342, 3343 HELENA LABORATORIES k013466 12/21/2001
abuscreen online opiates 300 / 2000 ROCHE DIAGNOSTICS CORP. k013482 12/21/2001
trident porous titanium acetabular component with peri-apatite coating HOWMEDICA OSTEONICS CORP. k013475 12/20/2001
codman slim-loc system Codman & Shurtleff, Inc. k013877 12/19/2001
convoy advanced delivery sheath kit BOSTON SCIENTIFIC k013866 12/14/2001
surgical dynamics meniscal staple UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC k013890 12/11/2001
z-net DEMITE LIMITED k001003 12/10/2001

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