FDA 510(k) Application Details - K151177

Device Classification Name

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510(K) Number K151177
Device Name XenMatrix AB Surgical Graft
Applicant C.R. Bard
100 Crossings Boulevard
Warwick, RI 02886 US
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Contact Tony John
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Regulation Number

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Classification Product Code PIJ
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Date Received 05/01/2015
Decision Date 07/30/2015
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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