510(k) K003206 ยท KXK Source, Brachytherapy, Radionuclide
GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005
| Applicant | Proxima Therapeutics, Inc., Alpharetta GA, US |
| Decision | Substantially Equivalent, Apr 25, 2001 |
| Received | Oct 13, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003206
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.