510(k) K202652
K202652 is an FDA 510(k) premarket notification submitted by S.A.L.F. Spa for the device "Servator P SALF Solution with THAM". The FDA issued a decision of Substantially Equivalent on August 19, 2021. The device falls under product code KDN (System, Perfusion, Kidney), a Class II device regulated under 21 CFR 876.5880. S.A.L.F. Spa has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 19, 2021
- Date Received
- September 14, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Perfusion, Kidney
- Device Class
- Class II
- Regulation Number
- 876.5880
- Review Panel
- GU
- Submission Type