510(k) K800425 ยท FKP System, Dialysate Delivery, Single Patient
GAMBRO AK-10-UDM-10-A ULTRADIFFUSION
| Applicant | Gambro, Inc., Walker MI, US |
| Decision | Substantially Equivalent, Apr 8, 1980 |
| Received | Feb 26, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K800425
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.