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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical
510(k) Number K142070
Device Name FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMIS
Applicant
Rti Surgical, Inc.
11621 Research Cir.
Alachua,  FL  32615
Applicant Contact KRISTINA HALL
Correspondent
Rti Surgical, Inc.
11621 Research Cir.
Alachua,  FL  32615
Correspondent Contact KRISTINA HALL
Regulation Number878.3300
Classification Product Code
FTM  
Subsequent Product Code
OXF  
Date Received07/30/2014
Decision Date 10/27/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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