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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 K062558
Device Name MESOSFOL SURGICAL FILM
Applicant
Biomet Manufacturing Corp
56 E. Bell Dr.,
P.O. Box 587
Warsaw,  IN  46581
Applicant Contact ERIKA MARTIN
Correspondent
Biomet Manufacturing Corp
56 E. Bell Dr.,
P.O. Box 587
Warsaw,  IN  46581
Correspondent Contact ERIKA MARTIN
Regulation Number878.3300
Classification Product Code
FTM  
Date Received08/30/2006
Decision Date 06/20/2007
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
Predetermined Change
Control Plan Authorized		 No
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