510(k) K210512 ยท FAJ Cystoscope And Accessories, Flexible/Rigid
LUMINELLE DTx System
| Applicant | Uvision360, Inc., Raleigh NC, US |
| Decision | Substantially Equivalent, Jun 30, 2021 |
| Received | Feb 23, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210512
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.