510(k) K083035 ยท NZT Dosimeter, Ionizing Radiation, Implanted
DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM
| Applicant | Sicel Technologies, Inc., Morrisville NC, US |
| Decision | Substantially Equivalent, Nov 13, 2008 |
| Received | Oct 14, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K083035
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.