510(k) K092458 ยท KXK Source, Brachytherapy, Radionuclide
PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS-131 PRELOADED STRANDS IN 18 GUAGE NEEDLES, MODEL PL-2
| Applicant | Isoray Medical, Inc., Richland WA, US |
| Decision | Substantially Equivalent, Aug 28, 2009 |
| Received | Aug 11, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K092458
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.