510(k) K963497 ยท MOT Irradiator, Blood To Prevent Graft Versus Host Disease
GAMMACELL 3000 ELAN, VERSION 1.0 AND GAMMACELL 1000 ELITE, VERSION 1.0
| Applicant | Nordion International, Inc., Kanata, Ontario, CA |
| Decision | Substantially Equivalent, Nov 8, 1996 |
| Received | Sep 3, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963497
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.