The following data is part of a premarket notification filed by Cr Bard Inc. with the FDA for Phasix St Mesh With Echo 2 Positioning System.
| Device ID | K182008 |
| 510k Number | K182008 |
| Device Name: | Phasix ST Mesh With Echo 2 Positioning System |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | CR Bard Inc. 100 Crossing Boulevard Warwick, RI 02886 |
| Contact | Shirin Mate |
| Correspondent | Shirin Mate CR Bard Inc. 100 Crossing Boulevard Warwick, RI 02886 |
| Product Code | FTL |
| Subsequent Product Code | GCJ |
| Subsequent Product Code | OOD |
| Subsequent Product Code | ORQ |
| Subsequent Product Code | OWT |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-27 |
| Decision Date | 2018-12-14 |
| Summary: | summary |