FDA 510(k) Application Details - K142706

Device Classification Name Mesh, Surgical, Polymeric

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510(K) Number K142706
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 09/22/2014
Decision Date 03/25/2015
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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