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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 K010760
Device Name ART BICARBONATE FOR HEMODIALYSIS, ART BICARBONATE LIQUID FOR HEMODIALYSIS
Applicant
ADVANCED RENAL TECHNOLOGIES, INC.
11838 N.E. 112TH ST.
KIRKLAND,  WA  98033
Applicant Contact ROBIN CALLAN
Correspondent
ADVANCED RENAL TECHNOLOGIES, INC.
11838 N.E. 112TH ST.
KIRKLAND,  WA  98033
Correspondent Contact ROBIN CALLAN
Regulation Number876.5820
Classification Product Code
KPO  
Date Received03/13/2001
Decision Date 06/11/2001
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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