510(k) K252180
Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W) by
Fresenius Medical Care Renal Therapies Group, LLC
— Product Code KPO
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 9, 2025
- Date Received
- July 11, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type