The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Phasix St Mesh With Open Positioning System.
| Device ID | K190185 |
| 510k Number | K190185 |
| Device Name: | Phasix ST Mesh With Open Positioning System |
| Classification | Mesh, Surgical, Absorbable, Abdominal Hernia |
| Applicant | C.R. Bard, Inc. 100 Crossings Boulevard Warwick, RI 02886 |
| Contact | Shirin Mate |
| Correspondent | Shirin Mate C.R. Bard, Inc. 100 Crossings Boulevard Warwick, RI 02886 |
| Product Code | OWT |
| Subsequent Product Code | FTL |
| Subsequent Product Code | MDM |
| Subsequent Product Code | OOD |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-01 |
| Decision Date | 2019-06-12 |