510(k) K243874 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120 (F00012972); FX CorAL 600 (F00012973); FX CorAL 800 (F00012974); FX CorAL 1000 (F00012975)
| Applicant | Fresenius Medical Care Renal Therapies Group, LLC, Waltham MA, US |
| Decision | Substantially Equivalent, Feb 28, 2025 |
| Received | Dec 17, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243874
No recall in the FDA data names this 510(k).
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