510(k) K192928 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Optiflux Enexa F500 Dialyzer
| Applicant | Fresenius Medical Care Reanal Therapies Group, LLC, Waltham MA, US |
| Decision | Substantially Equivalent, Jul 9, 2020 |
| Received | Oct 17, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192928
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.