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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 K160847
Device Name Rockwell Medical CitraPure Acid Concetrate
Applicant
ROCKWELL MEDICAL
30142 WIXOM ROAD
WIXOM,  MI  48393
Applicant Contact ROBERT CHIOINI
Correspondent
ROCKWELL MEDICAL
30142 WIXOM ROAD
WIXOM,  MI  48393
Correspondent Contact ROBERT CHIOINI
Regulation Number876.5820
Classification Product Code
KPO  
Date Received03/28/2016
Decision Date 10/20/2016
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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