510(k) K182259 ยท FTM Mesh, Surgical
Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal
| Applicant | Acell, Inc., Columbia MD, US |
| Decision | Substantially Equivalent, Feb 7, 2019 |
| Received | Aug 21, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182259
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.