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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 K142706
Device Name Modified ONFLEX Mesh
Applicant
C.R. Bard Inc.
100 Crossings Blvd.
Warwick,  RI  02886
Applicant Contact Mariya Buharin
Correspondent
C.R. Bard Inc.
100 Crossings Blvd.
Warwick,  RI  02886
Correspondent Contact Mariya Buharin
Regulation Number878.3300
Classification Product Code
FTL  
Date Received09/22/2014
Decision Date 03/25/2015
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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