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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 K983618
Device Name DRI-SATE MIXER FOR PREPARATION OF ACIDIFIED DIALYSATE CONCENTRATE
Applicant
ROCKWELL MEDICAL TECHNOLOGIES, INC.
28025 OAKLAND OAKS CT.
WIXOM,  MI  48393
Applicant Contact JEFFREY R SHIDEMAN
Correspondent
ROCKWELL MEDICAL TECHNOLOGIES, INC.
28025 OAKLAND OAKS CT.
WIXOM,  MI  48393
Correspondent Contact JEFFREY R SHIDEMAN
Regulation Number876.5820
Classification Product Code
KPO  
Date Received10/15/1998
Decision Date 08/05/1999
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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