510(k) K010166 ยท IWJ System, Applicator, Radionuclide, Manual
IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM
| Applicant | Imagyn Medical Technologies, Inc., Richland MI, US |
| Decision | Substantially Equivalent, Dec 3, 2001 |
| Received | Jan 18, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010166
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.