510(k) K190827 ยท HIH Hysteroscope (And Accessories)
Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid
| Applicant | Uvision360, Inc., Raleigh NC, US |
| Decision | Substantially Equivalent, Jun 6, 2019 |
| Received | Apr 1, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K190827
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.