510(k) K182540 ยท FDF Colonoscope And Accessories, Flexible/Rigid
DiLumen Endolumenal Interventional Platform
| Applicant | Lumendi, LLC, Westport CT, US |
| Decision | Substantially Equivalent, Oct 30, 2018 |
| Received | Sep 14, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182540
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.