510(k) K153632 ยท FTL Mesh, Surgical, Polymeric
Endoform Reconstructive Template
| Applicant | Aroa Biosurgery Limited (Formerly Mesynthes Limited), Auckland, NZ |
| Decision | Substantially Equivalent, Jun 16, 2016 |
| Received | Dec 18, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153632
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.