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FDA 510(k) Application Details - K152609
Device Classification Name
Mesh, Surgical, Polymeric
More FDA Info for this Device
510(K) Number
K152609
Device Name
Mesh, Surgical, Polymeric
Applicant
W.L GORE & ASSOCIATES, INC.
301 AIRPORT ROAD
ELKTON, MD 21921 US
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Contact
BARBARA L. SMITH
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
09/14/2015
Decision Date
12/11/2015
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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