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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 K113229
Device Name VENTRIO LIGHT HERNIA PATCH WITH TRM ANTIMICROBIAL COATING
Applicant
C.R. Bard, Inc.
100 Crossings Blvd.
Warwick,  RI  02886
Applicant Contact STEPHANIE BAKER
Correspondent
C.R. Bard, Inc.
100 Crossings Blvd.
Warwick,  RI  02886
Correspondent Contact STEPHANIE BAKER
Regulation Number878.3300
Classification Product Code
FTL  
Date Received11/02/2011
Decision Date 07/20/2012
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 Yes
Predetermined Change
Control Plan Authorized		 No
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