510(k) K191324 ยท KXK Source, Brachytherapy, Radionuclide
CivaDerm
| Applicant | Civatech Oncology, Inc., Durham NC, US |
| Decision | Substantially Equivalent, Sep 20, 2019 |
| Received | May 16, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191324
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.