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FDA 510(k) Application Details - K081069
Device Classification Name
Mesh, Surgical, Polymeric
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510(K) Number
K081069
Device Name
Mesh, Surgical, Polymeric
Applicant
W.L. GORE & ASSOCIATES,INC
301 AIRPORT RD.
ELKTON, MD 21921 US
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Contact
MICHAEL J TITUS
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
04/15/2008
Decision Date
05/30/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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