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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
Model 3300010, 3300020, 3300030, 3300040, 3300050
Device Name VENTRIO LIGHT HERNIA PATCH WITH TRM ANTIMICROBIAL COATING
Original Applicant
C.R. BARD, INC.
100 crossings boulevard
warwick,  RI  02886
Original Contact stephanie baker
Regulation Number878.3300
Classification Product Code
FTL  
Date Received11/02/2011
Decision Date 07/20/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product Yes
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