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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 K140501
Device Name XENMATRIX SURGICAL GRAFT
Applicant
C.R. BARD
100 CROSSINGS BOULEVARD
WARWICK,  RI  02886
Applicant Contact GINA CASSIDY
Correspondent
C.R. BARD
100 CROSSINGS BOULEVARD
WARWICK,  RI  02886
Correspondent Contact GINA CASSIDY
Regulation Number878.3300
Classification Product Code
FTM  
Subsequent Product Codes
OWV   OXH  
Date Received02/27/2014
Decision Date 04/28/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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