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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 K242155
Device Name DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)
Applicant
NIKKISO CO., LTD.
20-3, Ebisu 4-Chome, Shibuya-Ku
Tokyo,  JP 150-6022
Applicant Contact Satoko Hina
Correspondent
Healthcare Innovation Catalysts, Inc.
8024 Summer Mill Court
Bethesda,  MD  20817
Correspondent Contact Brittany Valdez Nava
Regulation Number876.5860
Classification Product Code
KDI  
Date Received07/23/2024
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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