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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 K983720
Device Name ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS AM-BIO-50,AM-BIO-65, AM-BIO-75, AND AM-BIO-100, AM-BIO-
Applicant
ASAHI MEDICAL CO., LTD.
15825 SHADY GROVE ROAD,
SUITE 90
ROCKVILLE,  MD  20850
Applicant Contact DAVID L WEST
Correspondent
ASAHI MEDICAL CO., LTD.
15825 SHADY GROVE ROAD,
SUITE 90
ROCKVILLE,  MD  20850
Correspondent Contact DAVID L WEST
Regulation Number876.5820
Classification Product Code
MSE  
Date Received10/21/1998
Decision Date 05/17/1999
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
Recalls CDRH Recalls
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