The following data is part of a premarket notification filed by Howmedica, Inc. with the FDA for Exeter Mesh.
| Device ID | K963940 |
| 510k Number | K963940 |
| Device Name: | EXETER MESH |
| Classification | Mesh, Surgical, Acetabular, Hip, Prosthesis |
| Applicant | HOWMEDICA, INC. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | Frank Maas |
| Correspondent | Frank Maas HOWMEDICA, INC. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Product Code | JDJ |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-01 |
| Decision Date | 1997-02-13 |
| Summary: | summary |