510(k) K162934 ยท FTM Mesh, Surgical
Biodesign Parastomal Hernia Repair Graft
| Applicant | Cook Biotech Incorporated, West Lafayette IN, US |
| Decision | Substantially Equivalent, Jul 10, 2017 |
| Received | Oct 20, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162934
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.