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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dialyzer, High Permeability With Or Without Sealed Dialysate System
510(k) Number K222067
FOIA Releasable 510(k) K222067
Device Name SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set
Applicant
Quanta Dialysis Technologies, Ltd.
Tything Rd.
Alcester,  GB B49 6EU
Applicant Contact Sam Drew
Correspondent
Quanta Dialysis Technologies, Ltd.
Tything Rd.
Alcester,  GB B49 6EU
Correspondent Contact Sam Drew
Regulation Number876.5860
Classification Product Code
KDI  
Subsequent Product Code
FJK  
Date Received07/13/2022
Decision Date 11/10/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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