510(k) K243595 ยท FTM Mesh, Surgical
OviTex PRS (Long-Term Resorbable)
| Applicant | TELA Bio, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Dec 19, 2024 |
| Received | Nov 20, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K243595
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.