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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 K123356
Device Name FORTIVA PORCINE DERMIS
Applicant
RTI BIOLOGICS, INC.
11621 RESEARCH CIRCLE
P.O. BOX 2650
ALACHUA,  FL  32616 -1627
Applicant Contact ESTHER CARBON
Correspondent
RTI BIOLOGICS, INC.
11621 RESEARCH CIRCLE
P.O. BOX 2650
ALACHUA,  FL  32616 -1627
Correspondent Contact ESTHER CARBON
Regulation Number878.3300
Classification Product Code
FTM  
Date Received10/31/2012
Decision Date 03/05/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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