510(k) K170945 ยท OXE Mesh, Surgical, Collagen, Staple Line Reinforcement
Biodesign Staple Line Reinforcement
| Applicant | Cook Biotech Incorporated, West Lafayette IN, US |
| Decision | Substantially Equivalent, Apr 28, 2017 |
| Received | Mar 30, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K170945
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.