K890601 is an FDA 510(k) clearance for the STUART TITANIUM SURGICAL MESH. This device is classified as a Mesh, Surgical, Metal (Class II - Special Controls, product code EZX).
Submitted by Stuart (Greensburg, US). The FDA issued a Cleared decision on March 16, 1989, 38 days after receiving the submission on February 6, 1989.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K890601 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 06, 1989 |
| Decision Date | March 16, 1989 |
| Days to Decision | 38 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | EZX — Mesh, Surgical, Metal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |