The following data is part of a premarket notification filed by Waldemar Link Gmbh & Co. Kg with the FDA for Link Acetabular Mesh.
| Device ID | K844225 |
| 510k Number | K844225 |
| Device Name: | LINK ACETABULAR MESH |
| Classification | Mesh, Surgical |
| Applicant | WALDEMAR LINK GMBH & CO. KG 10 GREAT MEADOW LN. E. Hanover, NJ 07936 |
| Contact | Ed Schussler |
| Correspondent | Ed Schussler WALDEMAR LINK GMBH & CO. KG 10 GREAT MEADOW LN. E. Hanover, NJ 07936 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-01 |
| Decision Date | 1984-11-14 |