510(k) K120344 ยท JAQ System, Applicator, Radionuclide, Remote-Controlled
RADIAPAK BRACHYTHERAPY APPLICATOR BALLOON DEVICE
| Applicant | Radiadyne, LLC (Specification Developer), Houston TX, US |
| Decision | Substantially Equivalent, May 3, 2012 |
| Received | Feb 3, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120344
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.