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FDA 510(k) Application Details - K142070
Device Classification Name
Mesh, Surgical
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510(K) Number
K142070
Device Name
Mesh, Surgical
Applicant
RTI SURGICAL, INC.
11621 Research Cir
ALACHUA, FL 32615 US
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Contact
KRISTINA HALL
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Regulation Number
878.3300
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Classification Product Code
FTM
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More FDA Info for this Product Code
Date Received
07/30/2014
Decision Date
10/27/2014
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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