510(k) K191696 ยท OXN Mesh, Surgical, Collagen, Fistula
Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft
| Applicant | Cook Biotech Incorporated, West Lafayette IN, US |
| Decision | Substantially Equivalent, Dec 27, 2019 |
| Received | Jun 25, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191696
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.