510(k) K010821 ยท KXK Source, Brachytherapy, Radionuclide
ECHOSEED/IODINE-125 SEEDS, MODEL 6733
| Applicant | Medi-Physics Inc. Dba Nycomed Amersham Imaging, Arlington Heights IL, US |
| Decision | Substantially Equivalent, Apr 11, 2001 |
| Received | Mar 19, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K010821
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.