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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
Original Applicant
RTI BIOLOGICS, INC.
11621 research circle
p.o. box 2650
alachua,  FL  32616 1627
Original 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 (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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