510(k) K123835
K123835 is an FDA 510(k) premarket notification submitted by Renal Solutions, Inc. for the device "2008 HEMODIALYSIS SORBENT SYSTEM". The FDA issued a decision of Substantially Equivalent on Feb 15, 2013. The device falls under product code FKT (System, Dialysate Delivery, Sorbent Regenerated), a Class II device regulated under 21 CFR 876.5600. Renal Solutions, Inc. has 8 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 15, 2013
- Date Received
- Dec 13, 2012
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- System, Dialysate Delivery, Sorbent Regenerated
- Device Class
- Class II
- Regulation Number
- 876.5600
- Review Panel
- GU
- Submission Type
- 510(k)