510(k) K183398 ยท FTM Mesh, Surgical
Endoform Restella
| Applicant | Aroa Biosurgery , Ltd., Mangere, NZ |
| Decision | Substantially Equivalent, Apr 11, 2019 |
| Received | Dec 7, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183398
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.