The following data is part of a premarket notification filed by Xylos Corporation with the FDA for Securian Tissue Reinforcement Matrix.
| Device ID | K083823 |
| 510k Number | K083823 |
| Device Name: | SECURIAN TISSUE REINFORCEMENT MATRIX |
| Classification | Mesh, Surgical |
| Applicant | XYLOS CORPORATION 838 TOWN CENTER DR. Langhorne, PA 19047 |
| Contact | Joyce Elkins |
| Correspondent | Joyce Elkins XYLOS CORPORATION 838 TOWN CENTER DR. Langhorne, PA 19047 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-22 |
| Decision Date | 2009-03-18 |
| Summary: | summary |