510(k) K921961 ยท IWJ System, Applicator, Radionuclide, Manual
SDMO APPLICATOR CODE: ASN.8236
| Applicant | Medi-Physics Inc. Dba Nycomed Amersham Imaging, Arlington Heights IL, US |
| Decision | Substantially Equivalent, Jul 1, 1992 |
| Received | Apr 27, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921961
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.