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FDA 510(k) Application Details - K032168
Device Classification Name
Mesh, Surgical, Polymeric
More FDA Info for this Device
510(K) Number
K032168
Device Name
Mesh, Surgical, Polymeric
Applicant
W. L. GORE & ASSOCIATES, INC.
3450 WEST KILTIE LN.
FLAGSTAFF, AZ 86001 US
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Contact
BRANDON HANSEN
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
07/16/2003
Decision Date
08/15/2003
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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