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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 K193670
Device Name SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set
Applicant
Quanta Dialysis Technologies Ltd.
Tything Road
Alcester,  GB B49 6EU
Applicant Contact Chris Rule
Correspondent
Quanta Dialysis Technologies Ltd.
Tything Road
Alcester,  GB B49 6EU
Correspondent Contact Chris Rule
Regulation Number876.5860
Classification Product Code
KDI  
Subsequent Product Code
FJK  
Date Received12/31/2019
Decision Date 12/23/2020
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
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