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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 K082687
Device Name COLLAMEND FM IMPLANT
Applicant
C.R. BARD, INC.
100 CROSSINGS BOULEVARD
WARWICK,  RI  02886
Applicant Contact KEVIN G STEVENS
Correspondent
C.R. BARD, INC.
100 CROSSINGS BOULEVARD
WARWICK,  RI  02886
Correspondent Contact KEVIN G STEVENS
Regulation Number878.3300
Classification Product Code
FTM  
Date Received09/15/2008
Decision Date 10/17/2008
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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