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 |