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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 K022521
Device Name BICARBONATE DIALYSATE CONCENTRATE MIXER, MODEL 50 GALLON & 100 GALLON
Applicant
ROCKWELL MEDICAL TECHNOLOGIES, INC.
30142 WIXOM RD.
WIXOM,  MI  48393
Applicant Contact DONALD DANALD
Correspondent
ROCKWELL MEDICAL TECHNOLOGIES, INC.
30142 WIXOM RD.
WIXOM,  MI  48393
Correspondent Contact DONALD DANALD
Regulation Number876.5820
Classification Product Code
KPO  
Date Received07/30/2002
Decision Date 01/03/2003
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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