510(k) K092534 ยท JAQ System, Applicator, Radionuclide, Remote-Controlled
ALATUS VAGINAL BALLOON PACKING SYSTEM
| Applicant | Radiadyne, Austin TX, US |
| Decision | Substantially Equivalent, Dec 7, 2009 |
| Received | Aug 19, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092534
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.