The following data is part of a premarket notification filed by C.r. Bard with the FDA for Xenmatrix Surgical Graft.
| Device ID | K140501 |
| 510k Number | K140501 |
| Device Name: | XENMATRIX SURGICAL GRAFT |
| Classification | Mesh, Surgical |
| Applicant | C.R. BARD 100 CROSSINGS BOULEVARD Warwick, RI 02886 |
| Contact | Gina Cassidy |
| Correspondent | Gina Cassidy C.R. BARD 100 CROSSINGS BOULEVARD Warwick, RI 02886 |
| Product Code | FTM |
| Subsequent Product Code | OWV |
| Subsequent Product Code | OXH |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-27 |
| Decision Date | 2014-04-28 |
| Summary: | summary |