FDA 510(k) Application Details - K082687

Device Classification Name Mesh, Surgical

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510(K) Number K082687
Device Name Mesh, Surgical
Applicant C.R. BARD, INC.
100 CROSSINGS BOULEVARD
WARWICK, RI 02886 US
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Contact KEVIN G STEVENS
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Regulation Number 878.3300

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Classification Product Code FTM
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Date Received 09/15/2008
Decision Date 10/17/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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