Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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
Predetermined Change
Control Plan Authorized		 No
-
-