The following data is part of a premarket notification filed by Xylos Corporation with the FDA for Xylos Macro-porous Surgical Mesh.
| Device ID | K111584 |
| 510k Number | K111584 |
| Device Name: | XYLOS MACRO-POROUS SURGICAL MESH |
| Classification | Mesh, Surgical |
| Applicant | XYLOS CORPORATION 838 TOWN CENTER DR. Langhorne, PA 19047 |
| Contact | Gonzalo C Serafica |
| Correspondent | Gonzalo C Serafica 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 | 2011-06-07 |
| Decision Date | 2011-08-25 |
| Summary: | summary |