510(k) K010985 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
GAMBRO POLYFLUX 6L, GAMBRO POLYFLUX 8L, GAMBRO POLYFLUX 10L, MODEL 6L, 8L, 10L
| Applicant | Gambro Renal Products, Lakewood CO, US |
| Decision | Substantially Equivalent, Oct 10, 2001 |
| Received | Apr 2, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010985
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.