The following data is part of a premarket notification filed by C.r. Bard Inc with the FDA for Phasix Plug And Patch.
| Device ID | K120728 |
| 510k Number | K120728 |
| Device Name: | PHASIX PLUG AND PATCH |
| Classification | Mesh, Surgical, Absorbable, Abdominal Hernia |
| Applicant | C.R. BARD INC 100 CROSSINGS BOULEVARD Warwick, RI 02886 |
| Contact | Sherma Winston |
| Correspondent | Sherma Winston C.R. BARD INC 100 CROSSINGS BOULEVARD Warwick, RI 02886 |
| Product Code | OWT |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-09 |
| Decision Date | 2012-10-22 |
| Summary: | summary |