The following data is part of a premarket notification filed by Davol, Inc. with the FDA for Usher's Marlex Tubular Mesh.
| Device ID | K792281 |
| 510k Number | K792281 |
| Device Name: | USHER'S MARLEX TUBULAR MESH |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | DAVOL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-11-13 |
| Decision Date | 1979-11-27 |