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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 K081538
Device Name TUTOPATCH, TUTOMESH
Applicant
RTI BIOLOGICS, INC.
11621 RESEARCH CIRCLE
P.O. BOX 2650
ALACHUA,  FL  32616 -1627
Applicant Contact TRAVIS AROLA
Correspondent
RTI BIOLOGICS, INC.
11621 RESEARCH CIRCLE
P.O. BOX 2650
ALACHUA,  FL  32616 -1627
Correspondent Contact TRAVIS AROLA
Regulation Number878.3300
Classification Product Code
FTM  
Subsequent Product Codes
DXZ   OXH   PAJ  
Date Received06/02/2008
Decision Date 06/19/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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