FDA 510(k) Application Details - K150906

Device Classification Name Mesh, Surgical, Polymeric

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510(K) Number K150906
Device Name Mesh, Surgical, Polymeric
Applicant EHICON INC.
ROUTE22 WEST, P.O. BOX 151
SOMERVILLE, NJ 08876-0151 US
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Contact SUSAN LIN
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Regulation Number 878.3300

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Classification Product Code FTL
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Date Received 04/03/2015
Decision Date 07/24/2015
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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