FDA 510(k) Application Details - K082216

Device Classification Name Mesh, Surgical, Polymeric

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510(K) Number K082216
Device Name Mesh, Surgical, Polymeric
Applicant ETHICON INC.
ROUTE 22 WEST
PO BOX 151
SOMERVILLE, NJ 08876 US
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Contact BRYAN A LISA
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Regulation Number 878.3300

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Classification Product Code FTL
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Date Received 08/06/2008
Decision Date 09/05/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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