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FDA 510(k) Application Details - K100313
Device Classification Name
Mesh, Surgical, Polymeric
More FDA Info for this Device
510(K) Number
K100313
Device Name
Mesh, Surgical, Polymeric
Applicant
MIMEDX GROUP, INC
811 LIVINGSTON COURT SE
SUITE B
MARIETTA, GA 30067 US
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Contact
SALLY THORSEN
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
02/04/2010
Decision Date
06/14/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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