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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemodialyzer, Re-Use, Low Flux
510(k) Number K970650
Device Name ASAHI AM-R SERIES DIALYZERS
Applicant
Asahi Medical Co., Ltd.
15825 Shady Grove Rd.,
Suite 90
Rockville,  MD  20850
Applicant Contact DAVID L WEST
Correspondent
Asahi Medical Co., Ltd.
15825 Shady Grove Rd.,
Suite 90
Rockville,  MD  20850
Correspondent Contact DAVID L WEST
Regulation Number876.5820
Classification Product Code
MSE  
Date Received02/20/1997
Decision Date 09/30/1997
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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