510(k) K823546
K823546 is an FDA 510(k) premarket notification submitted by Renal Systems, Inc. for the device "RENAFLO II". The FDA issued a decision of Substantially Equivalent on December 16, 1982. The device falls under product code KOC (Accessories, Blood Circuit, Hemodialysis), a Class II device regulated under 21 CFR 876.5820. Renal Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 16, 1982
- Date Received
- November 30, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessories, Blood Circuit, Hemodialysis
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type