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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tank, holding, dialysis
510(k) Number K031502
Device Name USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEM
Applicant
USFILTER
725 WOOTEN RD.
COLORADO SPRINGS,  CO  80915
Applicant Contact EDWARD L ARMSTRONG
Correspondent
USFILTER
725 WOOTEN RD.
COLORADO SPRINGS,  CO  80915
Correspondent Contact EDWARD L ARMSTRONG
Regulation Number876.5820
Classification Product Code
FIN  
Date Received05/13/2003
Decision Date 08/27/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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