The following data is part of a premarket notification filed by C.r. Bard with the FDA for Xenmatrix Ab Surgical Graft.
| Device ID | K162193 |
| 510k Number | K162193 |
| Device Name: | XenMatrix AB Surgical Graft |
| Classification | Collagen Surgical Mesh Containing Drugs |
| Applicant | C.R. Bard 100 Crossings Boulevard Warwick, RI 02886 |
| Contact | Tony John |
| Correspondent | Tony John C.R. Bard 100 Crossings Boulevard Warwick, RI 02886 |
| Product Code | PIJ |
| Subsequent Product Code | FTM |
| Subsequent Product Code | OXH |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2016-08-04 |
| Decision Date | 2016-12-23 |
| Summary: | summary |