FDA 510(k) Application Details - K972412

Device Classification Name Mesh, Surgical, Polymeric

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510(K) Number K972412
Device Name Mesh, Surgical, Polymeric
Applicant ETHICON, INC.
ROUTE 22 WEST
P.O. BOX 151
SOMERVILLE, NJ 08876-0151 US
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Contact GREGORY R JONES
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Regulation Number 878.3300

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Classification Product Code FTL
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Date Received 06/26/1997
Decision Date 09/10/1997
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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