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FDA 510(k) Application Details - K082216
Device Classification Name
Mesh, Surgical, Polymeric
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
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
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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