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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dialyzer, capillary, hollow fiber
510(k) Number K854575
Device Name MODIFIED AM-SERIES DIALYZERS
Applicant
ASAHI MEDICAL CO., LTD.
INT'L SQUARE
1825 EYE STREET NW #400
WASHINGTON,  DC  2006
Applicant Contact RICHARD T NEY
Correspondent
ASAHI MEDICAL CO., LTD.
INT'L SQUARE
1825 EYE STREET NW #400
WASHINGTON,  DC  2006
Correspondent Contact RICHARD T NEY
Regulation Number876.5820
Classification Product Code
FJI  
Date Received11/06/1985
Decision Date 12/02/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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