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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 K101928
Device Name VENTRALEX ST HERNIA PATCH
Applicant
C.R. Bard, Inc.
100 Crossings Blvd.
Warwick,  RI  02886
Applicant Contact MICHELLE GODIN
Correspondent
C.R. Bard, Inc.
100 Crossings Blvd.
Warwick,  RI  02886
Correspondent Contact MICHELLE GODIN
Regulation Number878.3300
Classification Product Code
FTL  
Date Received07/09/2010
Decision Date 03/23/2011
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
Recalls CDRH Recalls
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