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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 K231589
Device Name Blood Tubing Lines for Hemodialysis AV06C-E
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 130-0023
Correspondent Contact Fumiaki Kanai
Regulation Number876.5820
Classification Product Code
KOC  
Date Received06/01/2023
Decision Date 07/28/2023
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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