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FDA 510(k), K222067, SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set
FDA 510(k), K222067, SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set
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$49.00 USD
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$49.00 USD
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510(K) Number: K222067
Device Name: SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set
Manufacturer: Sam Drew
Device Classification Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
Regulation Number: KDI
Classification Product Code: KXA
Date Received: 07/13/2022
Decision Date: 11/10/2022
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set
Manufacturer: Sam Drew
Device Classification Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
Regulation Number: KDI
Classification Product Code: KXA
Date Received: 07/13/2022
Decision Date: 11/10/2022
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
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