510(k) K161395 ยท KXK Source, Brachytherapy, Radionuclide
SPEC Model M13
| Applicant | Source Production and Equipment Co., Inc., Saint Rose LA, US |
| Decision | Substantially Equivalent, Jul 6, 2016 |
| Received | May 19, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161395
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.