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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
510(k) Number K243607
Device Name Moda-flx Hemodialysis System™ Cartridge (102121-001 )
Applicant
Diality, Inc.
181 Technology Dr., Suite 150
Irvine,  CA  92618
Applicant Contact Clayton Poppe
Correspondent
Diality, Inc.
181 Technology Dr., Suite 150
Irvine,  CA  92618
Correspondent Contact Clayton Poppe
Regulation Number876.5820
Classification Product Code
FJK  
Date Received11/21/2024
Decision Date 12/20/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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