The following data is part of a premarket notification filed by C.r. Bard Inc. with the FDA for Phasix Mesh.
| Device ID | K161424 |
| 510k Number | K161424 |
| Device Name: | Phasix Mesh |
| Classification | Surgical Film |
| Applicant | C.R. BARD INC. 100 CROSSINGS BOULEVARD Warwick, RI 02886 |
| Contact | Janna Babson |
| Correspondent | Janna Babson C.R. BARD INC. 100 CROSSINGS BOULEVARD Warwick, RI 02886 |
| Product Code | OOD |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-23 |
| Decision Date | 2016-09-29 |
| Summary: | summary |