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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 K233798
Device Name Moda-flx Hemodialysis System and Cartridge
Applicant
Diality, Inc.
181 Technology Drive
Suite 150
Irvine,  CA  92618
Applicant Contact Clayton Poppe
Correspondent
Diality, Inc.
181 Technology Drive
Suite 150
Irvine,  CA  92618
Correspondent Contact Tori Anaya
Regulation Number876.5860
Classification Product Code
KDI  
Subsequent Product Codes
FIP   FJK  
Date Received11/29/2023
Decision Date 08/02/2024
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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