510(k) K992963 ยท KXK Source, Brachytherapy, Radionuclide
I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401
| Applicant | International Isotopes, Inc., Denton TX, US |
| Decision | Substantially Equivalent, Sep 21, 1999 |
| Received | Sep 2, 1999 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K992963
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.