510(k) K211819 ยท FDF Colonoscope And Accessories, Flexible/Rigid
DiLumen C2 and Tool Mount
| Applicant | Lumendi, LLC, Westport CT, US |
| Decision | Substantially Equivalent, Oct 22, 2021 |
| Received | Jun 11, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211819
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.