510(k) K043336 ยท KXK Source, Brachytherapy, Radionuclide
OPTISTRAND, MODEL 1032S
| Applicant | Ibt SA, Norcross GA, US |
| Decision | Substantially Equivalent, Jan 21, 2005 |
| Received | Dec 3, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043336
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.