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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 K061746
Device Name COLLAGUARD, MODEL FCIA,FCIB,FCIC,AND FCID
Applicant
Innocoll Pharmaceuticals
Ida Business And Technology
Park, Garrycastle
Athlone, Co. Westmeath,  IE
Applicant Contact AARON WYSE
Correspondent
Innocoll Pharmaceuticals
Ida Business And Technology
Park, Garrycastle
Athlone, Co. Westmeath,  IE
Correspondent Contact AARON WYSE
Classification Product Code
KGN  
Date Received06/21/2006
Decision Date 10/02/2006
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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