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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 K855212
Device Name ASAHI AM SERIES DIALYZERS
Applicant
ADVOCACY INTERNATIONAL, LTD.
INTERNATIONA SQUARE
1825 EYE STREET N.W. SUITE 400
WASHINGTON,  DC  20006
Applicant Contact RICHARD T NEY
Correspondent
ADVOCACY INTERNATIONAL, LTD.
INTERNATIONA SQUARE
1825 EYE STREET N.W. SUITE 400
WASHINGTON,  DC  20006
Correspondent Contact RICHARD T NEY
Regulation Number876.5820
Classification Product Code
FJI  
Date Received12/30/1985
Decision Date 01/21/1986
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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