510(k) K163645 ยท OMD Cutaneous Tissue Adhesive With Mesh
DERMABOND PRINEO Skin Closure System
| Applicant | Ethicon, LLC, Somerville NJ, US |
| Decision | Substantially Equivalent, Apr 21, 2017 |
| Received | Dec 23, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163645
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.