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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
510(k) Number K000792
Device Name CITRASATE DIALYSATE ACID CONCENTRATE LIQUID, MODELS CS-1XXX-XX, CS-XXX-XX, CS-3XXX-XX
Applicant
Advanced Renal Technologies, Inc.
11838 NE 112th St.
Kirkland,  WA  98033
Applicant Contact ROBIN CALLAN
Correspondent
Advanced Renal Technologies, Inc.
11838 NE 112th St.
Kirkland,  WA  98033
Correspondent Contact ROBIN CALLAN
Regulation Number876.5820
Classification Product Code
KPO  
Date Received03/10/2000
Decision Date 06/08/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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