510(k) K150594 ยท KHJ Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Biodesign Otologic Repair Graft
| Applicant | Cook Biotech Incorprated, West Lafayette IN, US |
| Decision | Substantially Equivalent, Sep 16, 2015 |
| Received | Mar 9, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150594
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.