The following data is part of a premarket notification filed by C.r. Bard Inc. with the FDA for Echo 2.0 Lap System With Ventralight St Mesh.
Device ID | K143743 |
510k Number | K143743 |
Device Name: | ECHO 2.0 LAP SYSTEM With VENTRALIGHT ST MESH |
Classification | Mesh, Surgical, Polymeric |
Applicant | C.R. Bard Inc. 100 Crossings Blvd. Warwick, RI 02886 |
Contact | Felicia Ruley |
Correspondent | Andrew Harrell C.R. Bard Inc. 100 Crossings Blvd. Warwick, RI 02886 |
Product Code | FTL |
Subsequent Product Code | GCJ |
Subsequent Product Code | ORQ |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-12-31 |
Decision Date | 2015-09-18 |
Summary: | summary |