510(k) K181909 ยท FAJ Cystoscope And Accessories, Flexible/Rigid
Luminelle DTx Hysteroscopy System
| Applicant | Uvision360, Inc., Raleigh NC, US |
| Decision | Substantially Equivalent, Aug 16, 2018 |
| Received | Jul 17, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181909
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.