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FDA 510(k), K193670, SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set
FDA 510(k), K193670, SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set
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$149.00 USD
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510(K) Number: K193670
Device Name: SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set
Manufacturer: Quanta Dialysis Technologies Ltd.
Device Classification Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
Regulation Number: 876.5860
Classification Product Code: KDI
Date Received: 12/31/2019
Decision Date: 12/23/2020
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set
Manufacturer: Quanta Dialysis Technologies Ltd.
Device Classification Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
Regulation Number: 876.5860
Classification Product Code: KDI
Date Received: 12/31/2019
Decision Date: 12/23/2020
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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