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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, polymeric
510(k) Number K093166
Device Name WITTMANN PATCH
Applicant
APERTA LLC
990 GULF WINDS WAY
CASEY KEY NOKOMIS,  FL  34275
Applicant Contact DIETMAR H WITTMANN
Correspondent
APERTA LLC
990 GULF WINDS WAY
CASEY KEY NOKOMIS,  FL  34275
Correspondent Contact DIETMAR H WITTMANN
Regulation Number878.3300
Classification Product Code
FTL  
Date Received10/06/2009
Decision Date 12/07/2009
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
Recalls CDRH Recalls
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