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 |