510(k) K801480 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
GAMBRO LUNDIA MAJOR HIGH FLUX HEMODIALYZ
| Applicant | Gambro, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Aug 27, 1980 |
| Received | Jun 24, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K801480
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.