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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Dialysate Delivery, Central Multiple Patient
510(k) Number K852359
Device Name AMUCHINA/DIALYZER DISINFECTANT
Applicant
AMUCHINA INTL., INC.
1030 FIFTEENTH ST. NW
EXECUTIVE BLDG. #720
WASHINGTON,  DC  20005
Applicant Contact BERNARD J COONEY
Correspondent
AMUCHINA INTL., INC.
1030 FIFTEENTH ST. NW
EXECUTIVE BLDG. #720
WASHINGTON,  DC  20005
Correspondent Contact BERNARD J COONEY
Regulation Number876.5820
Classification Product Code
FKQ  
Date Received06/04/1985
Decision Date 05/13/1986
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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