FDA 510(k) Application Details - K112888

Device Classification Name Dressing, Wound, Collagen

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510(K) Number K112888
Device Name Dressing, Wound, Collagen
Applicant KENSEY NASH CORPORATION
735 PENNSYLVANIA DRIVE
EXTON, PA 19341 US
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Contact LORI A BURNS
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Regulation Number 000.0000

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Classification Product Code KGN
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Date Received 09/30/2011
Decision Date 02/10/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
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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