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 |