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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wound Dressing With Animal-Derived Material(S)
510(k) Number K092096
Device Name ENDOFORM DERMAL TEMPLATE
Applicant
Mesynthes, Ltd.
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact MARY MCNAMARA
Correspondent
Mesynthes, Ltd.
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact MARY MCNAMARA
Classification Product Code
KGN  
Date Received07/14/2009
Decision Date 01/21/2010
Decision Substantially Equivalent (SESE)
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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