The following data is part of a premarket notification filed by Xylos Corporation with the FDA for Xylos Surgical Mesh.
| Device ID | K023237 |
| 510k Number | K023237 |
| Device Name: | XYLOS SURGICAL MESH |
| Classification | Mesh, Surgical |
| Applicant | XYLOS CORPORATION 815 CONNECTICUT AVE., NW. SUITE 800 Washington, DC 20006 |
| Contact | Patsy Trisler |
| Correspondent | Patsy Trisler XYLOS CORPORATION 815 CONNECTICUT AVE., NW. SUITE 800 Washington, DC 20006 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-27 |
| Decision Date | 2003-03-18 |
| Summary: | summary |