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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Peritoneal, Automatic Delivery
510(k) Number K862928
Device Name AMUKIN-50% FOR CAPD Y-SET
Applicant
AMUCHINA INTL., INC.
12120A HERITAGE PARK CIRCLE
SILVER SPRING,  MD  20906
Applicant Contact BERNARD J COONEY
Correspondent
AMUCHINA INTL., INC.
12120A HERITAGE PARK CIRCLE
SILVER SPRING,  MD  20906
Correspondent Contact BERNARD J COONEY
Regulation Number876.5630
Classification Product Code
FKX  
Date Received08/01/1986
Decision Date 03/09/1987
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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