The following data is part of a premarket notification filed by C. R. Bard Inc with the FDA for Phasix St Mesh.
| Device ID | K143380 |
| 510k Number | K143380 |
| Device Name: | Phasix ST Mesh |
| Classification | Mesh, Surgical, Absorbable, Abdominal Hernia |
| Applicant | C. R. Bard Inc 100 Crossing Boulevard Warwick, RI 02886 |
| Contact | Tony John |
| Correspondent | Tony John C. R. Bard Inc 100 Crossing Boulevard Warwick, RI 02886 |
| Product Code | OWT |
| Subsequent Product Code | FTL |
| Subsequent Product Code | OOD |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-25 |
| Decision Date | 2015-06-05 |
| Summary: | summary |