510(k) K023064
K023064 is an FDA 510(k) premarket notification submitted by Krd Co., Ltd. for the device "HEMOCLEAN". The FDA issued a decision of Substantially Equivalent on April 6, 2004. The device falls under product code NII (Disinfectant, Dialysate Delivery System), a Class II device regulated under 21 CFR 876.5860.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 6, 2004
- Date Received
- September 16, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Disinfectant, Dialysate Delivery System
- Device Class
- Class II
- Regulation Number
- 876.5860
- Review Panel
- HO
- Submission Type
Disinfectant intended for reprocessing dialysate delivery systems.