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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 K162248
Device Name Asahi ViE-U Series Dialyzer
Applicant
Asahi Kasei Medical Co., Ltd.
1-105 Kanda Jinbocho
Chiyoda-Ku,  JP 101-8101
Applicant Contact Masaharu Aritomi
Correspondent
Boston Biomedical Associates
100 Crowley Dr.
Suite 216
Marlborough,  MA  01752
Correspondent Contact Megan Shackelford
Regulation Number876.5860
Classification Product Code
KDI  
Date Received08/10/2016
Decision Date 05/03/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Clinical Trials NCT02292212
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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