The following data is part of a premarket notification filed by Cr Bard with the FDA for Ventralight St Mesh With Echo 2 Positioning System 11cm (4.5”) Circle, Ventralight St Mesh With Echo 2 Positioning System 10cm X 15cm (4”x 6”) Ellipse, Ventralight St Mesh With Echo 2 Positioning System 15cm (6”) Circle, Ventralight St Mesh With Echo.
| Device ID | K170294 |
| 510k Number | K170294 |
| Device Name: | VENTRALIGHT ST Mesh With ECHO 2 Positioning System 11cm (4.5”) Circle, VENTRALIGHT ST Mesh With ECHO 2 Positioning System 10cm X 15cm (4”x 6”) Ellipse, VENTRALIGHT ST Mesh With ECHO 2 Positioning System 15cm (6”) Circle, VENTRALIGHT ST Mesh With ECHO |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | CR BARD 100 CROSSING BLVD Warwick, RI 02886 |
| Contact | Christine Lloyd |
| Correspondent | Christine Lloyd CR BARD 100 CROSSING 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 | 2017-01-31 |
| Decision Date | 2017-05-01 |
| Summary: | summary |