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FDA 510(k) Application Details - K181268
Device Classification Name
Mesh, Surgical, Polymeric
More FDA Info for this Device
510(K) Number
K181268
Device Name
Mesh, Surgical, Polymeric
Applicant
Ethicon, Inc.
Route 22 West
P.O Box 151
Somerville, NJ 08876-0151 US
Other 510(k) Applications for this Company
Contact
Melina Escobar
Other 510(k) Applications for this Contact
Regulation Number
878.3300
More FDA Info for this Regulation Number
Classification Product Code
FTL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/14/2018
Decision Date
07/26/2018
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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