510(k) K191461 ยท OMD Cutaneous Tissue Adhesive With Mesh
Exofin Fusion Skin Closure System
| Applicant | Chemence Medical, Inc., Alpharetta GA, US |
| Decision | Substantially Equivalent, Jun 5, 2020 |
| Received | Jun 3, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191461
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.