The following data is part of a premarket notification filed by Stuart with the FDA for Stuart Titanium Surgical Mesh.
| Device ID | K890601 |
| 510k Number | K890601 |
| Device Name: | STUART TITANIUM SURGICAL MESH |
| Classification | Mesh, Surgical, Metal |
| Applicant | STUART ONE STUART PLAZA DONOHUE/LUXOR ROADS Greensburg, PA 15601 |
| Contact | Abraham Glasser |
| Correspondent | Abraham Glasser STUART ONE STUART PLAZA DONOHUE/LUXOR ROADS Greensburg, PA 15601 |
| Product Code | EZX |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-06 |
| Decision Date | 1989-03-16 |