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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 K062399
Device Name ROCKWELL MEDICALTECHNOLOGIES, INC. CITRAPURE
Applicant
ROCKWELL MEDICAL TECHNOLOGIES, INC.
30142 WIXOM RD.
WIXOM,  MI  48393
Applicant Contact ROB CHIOINI
Correspondent
ROCKWELL MEDICAL TECHNOLOGIES, INC.
30142 WIXOM RD.
WIXOM,  MI  48393
Correspondent Contact ROB CHIOINI
Regulation Number876.5820
Classification Product Code
KPO  
Date Received08/16/2006
Decision Date 11/17/2006
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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