510(k) K111931 ยท KXK Source, Brachytherapy, Radionuclide
GLIASITE RTS
| Applicant | Isoray Medical, Inc., Richland WA, US |
| Decision | Substantially Equivalent, Aug 5, 2011 |
| Received | Jul 8, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K111931
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.