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 |