510(k) K050963 ยท MOT Irradiator, Blood To Prevent Graft Versus Host Disease
GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN
| Applicant | Mds Nordion, Ottawa, CA |
| Decision | Substantially Equivalent, May 20, 2005 |
| Received | Apr 18, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K050963
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.