FDA 510(k) Application Details - K103787

Device Classification Name Mesh, Surgical

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510(K) Number K103787
Device Name Mesh, Surgical
Applicant KENSEY NASH CORP.
735 PENNSYLVANIA DRIVE
EXTON, PA 19341 US
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Contact Lori Burns
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Regulation Number 878.3300

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Classification Product Code FTM
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Date Received 12/27/2010
Decision Date 02/07/2011
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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