510(k) K181935 ยท FTL Mesh, Surgical, Polymeric
Endoform Reconstructive Template - Non Absorbable
| Applicant | Aroa Biosurgery , Ltd., Mangere, NZ |
| Decision | Substantially Equivalent, Dec 4, 2018 |
| Received | Jul 19, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181935
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.