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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 K153344
Device Name Asahi REXEED-S Series Dialyzer
Applicant
Asahi Kasei Medical Co., Ltd.
1-105 Kanda Jinbocho
Chiyoda-ku,  JP 101-8101
Applicant Contact Hidenobu Nakazawa
Correspondent
Qserve Group US, Inc.
5600 Wisconsin Avenue, #509
Chevy Chase,  MD  20815
Correspondent Contact Patsy Trisler
Regulation Number876.5860
Classification Product Code
KDI  
Date Received11/19/2015
Decision Date 12/17/2015
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
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