The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Xenmatrix Ab Surgical Graft.
| Device ID | K133223 |
| 510k Number | K133223 |
| Device Name: | XENMATRIX AB SURGICAL GRAFT |
| Classification | Collagen Surgical Mesh Containing Drugs |
| Applicant | C.R. BARD, INC. 100 CROSSINGS BLVD. Warwick, RI 02886 |
| Contact | Tony John |
| Correspondent | Tony John C.R. BARD, INC. 100 CROSSINGS BLVD. 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 | 2013-10-21 |
| Decision Date | 2014-09-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00801741074301 | K133223 | 000 |
| 00801741074189 | K133223 | 000 |
| 00801741074196 | K133223 | 000 |
| 00801741074202 | K133223 | 000 |
| 00801741074219 | K133223 | 000 |
| 00801741074226 | K133223 | 000 |
| 00801741074233 | K133223 | 000 |
| 00801741074240 | K133223 | 000 |
| 00801741074257 | K133223 | 000 |
| 00801741074264 | K133223 | 000 |
| 00801741074271 | K133223 | 000 |
| 00801741074288 | K133223 | 000 |
| 00801741074295 | K133223 | 000 |
| 00801741074172 | K133223 | 000 |