510(k) K192443 · FTL Mesh, Surgical, Polymeric
Dextile Anatomical Mesh
| Applicant | Sofradim Production, Trévoux, FR |
| Decision | Substantially Equivalent, Dec 6, 2019 |
| Received | Sep 6, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192443
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.