510(k) K913950 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
DUO-FLUX(R) ULTRA HIGH PERFORM ARTIFICIAL KIDNEY
| Applicant | Althin Medical AB an Affiliate of Baxter Intl, Miami Lakes FL, US |
| Decision | Substantially Equivalent, Nov 1, 1991 |
| Received | Sep 4, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913950
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.