510(k) K203062 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Optiflux Series of Dialyzers F160NR, F180NR, F200NR
| Applicant | Fresenius Medical Care Renal Therapies Group, LLC, Waltham MA, US |
| Decision | Substantially Equivalent, Dec 28, 2020 |
| Received | Oct 9, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203062
No recall in the FDA data names this 510(k).
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