FDA 510(k) Application Details - K132441

Device Classification Name Mesh, Surgical, Polymeric

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510(K) Number K132441
Device Name Mesh, Surgical, Polymeric
Applicant C.R. BARD, INC.
100 CROSSINGS BLVD.
WARWICK, RI 02886 US
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Contact MARIYA BUHARIN
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Regulation Number 878.3300

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Classification Product Code FTL
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Date Received 08/06/2013
Decision Date 12/13/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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