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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 K023985
Device Name ACIDIFIED COMPONENT CONCENTRATES FOR BICARBONATE DIALYSIS CONTAINING DI-ACETATE
Applicant
ROCKWELL MEDICAL TECHNOLOGIES, INC.
30142 WIXOM RD.
WIXOM,  MI  48393
Applicant Contact GERRY FRITZ
Correspondent
ROCKWELL MEDICAL TECHNOLOGIES, INC.
30142 WIXOM RD.
WIXOM,  MI  48393
Correspondent Contact GERRY FRITZ
Regulation Number876.5820
Classification Product Code
KPO  
Date Received12/02/2002
Decision Date 02/28/2003
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
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