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FDA 510(k) Application Details - K112784
Device Classification Name
Mesh, Surgical, Polymeric
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510(K) Number
K112784
Device Name
Mesh, Surgical, Polymeric
Applicant
SMITH & NEPHEW, INC.
970 LAKE CARILLON DRIVE
SUITE 110
ST. PETERSBURG, FL 33716 US
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Contact
LAURA D REYNOLDS
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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
09/26/2011
Decision Date
11/22/2011
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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