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FDA 510(k) Application Details - K071249
Device Classification Name
Mesh, Surgical, Polymeric
More FDA Info for this Device
510(K) Number
K071249
Device Name
Mesh, Surgical, Polymeric
Applicant
ETHICON, INC.
U.S. ROUTE 22, WEST
P.O. BOX 151
SOMERVILLE, NJ 08876-0151 US
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PATRICE NAPODA
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Regulation Number
878.3300
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Classification Product Code
FTL
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More FDA Info for this Product Code
Date Received
05/04/2007
Decision Date
06/05/2007
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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