510(k) K010667 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
GAMBRO POLYFLUX 24S, GAMBRO POLYFLUX 24R
| Applicant | Gambro Renal Products, Lakewood CO, US |
| Decision | Substantially Equivalent, Jun 4, 2001 |
| Received | Mar 6, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010667
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.