510(k) K220721
FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000 by
Fresenius Medical Care Renal Therapies Group, LLC
— Product Code KDI
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 11, 2023
- Date Received
- March 14, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Device Class
- Class II
- Regulation Number
- 876.5860
- Review Panel
- GU
- Submission Type