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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 K091142
Device Name TUTOPATCH, TUTOMESH, MODELS 68350, 68351, 68352, 68353, 68354, 68355, 68356, 68357, 68358
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  
Date Received04/20/2009
Decision Date 08/31/2009
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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