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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 K991296
Device Name TUTOPATCH
Original Applicant
TUTOGEN MEDICAL U.S., INC.
13709 progress blvd.
box 19 south wing
alachua,  FL  32615
Original Contact pj pardo
Regulation Number878.3300
Classification Product Code
FTM  
Subsequent Product Codes
DXZ   OXH   PAJ  
Date Received04/15/1999
Decision Date 10/06/2000
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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