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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 K143743
Device Name ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESH
Applicant
C.R. Bard Inc.
100 Crossings Blvd.
Warwick,  RI  02886
Applicant Contact FELICIA RULEY
Correspondent
C.R. Bard Inc.
100 Crossings Blvd.
Warwick,  RI  02886
Correspondent Contact ANDREW HARRELL
Regulation Number878.3300
Classification Product Code
FTL  
Subsequent Product Codes
GCJ   ORQ  
Date Received12/31/2014
Decision Date 09/18/2015
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
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