510(k) K161000 ยท KHJ Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Biodesign Otologic Repair Graft
| Applicant | Cook Biotech Incorporated, West Lafayette IN, US |
| Decision | Substantially Equivalent, May 11, 2016 |
| Received | Apr 11, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K161000
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.