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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Device Name
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Applicant
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510(K)
Number
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Decision
Date
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denlaser, model 800 CAO GROUP, INC. k003541 01/25/2001
acumatch l-series unipolar endoprosthesis EXACTECH, INC. k010081 02/05/2001
r & d designation ap-035 JENSEN INDUSTRIES, INC. k010414 03/27/2001
lfit v40 femoral head components HOWMEDICA OSTEONICS CORP. k010757 04/11/2001
pacing lead bipolar adapters and extensions Oscor Inc. k010787 05/22/2001
geratherm babywatch temperature monitor GERATHERM AG k001281 06/12/2001
ics medical chartr oae with tymp ICS MEDICAL CORP. k011181 06/25/2001
brightway brand powder free latex examination gloves, blue non-sterile, protein labeling claim (50 micrograms or less) ( BRIGHTWAY HOLDINGS SDN. BHD. k011728 07/09/2001
central venous catheter BOSTON SCIENTIFIC CORP. k003839 08/01/2001
baumer locking nail BAUMER S.A. k011504 08/14/2001

*   The maximum 500 records meeting your search criteria returned. Please narrow your search.
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