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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Blood Circuit, Hemodialysis
510(k) Number K242176
Device Name BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U)
Applicant
NIKKISO CO., LTD.
20-3, Ebisu 4-Chome
Shibuya-Ku,  JP 150-6022
Applicant Contact Satoko Hina
Correspondent
Mic International
4-32-16 Ryogoku
Sumida-Ku,  JP 103-0026
Correspondent Contact Fumiaki Kanai
Regulation Number876.5820
Classification Product Code
KOC  
Date Received07/24/2024
Decision Date 05/15/2025
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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