The following data is part of a premarket notification filed by Xylos Corporation with the FDA for Modification To Xylos Surgical Mesh.
| Device ID | K081882 |
| 510k Number | K081882 |
| Device Name: | MODIFICATION TO XYLOS SURGICAL MESH |
| Classification | Mesh, Surgical |
| Applicant | XYLOS CORPORATION 838 TOWN CENTER DR. Langhorne, PA 19047 |
| Contact | Gerry Ann Oster |
| Correspondent | Gerry Ann Oster XYLOS CORPORATION 838 TOWN CENTER DR. Langhorne, PA 19047 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-02 |
| Decision Date | 2008-07-11 |
| Summary: | summary |