510(k) K153364 ยท OXE Mesh, Surgical, Collagen, Staple Line Reinforcement
Kerecis SecureMesh
| Applicant | Kerecis Limited, Isafjordur, IS |
| Decision | Substantially Equivalent, Aug 19, 2016 |
| Received | Nov 20, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153364
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.