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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 K981003
Device Name ROCKWELL MEDICAL SUPPLY, LLC. DRI-SATE ACID CONCENTRATE MIXES
Applicant
INTERNATIONAL MEDICAL PRODUCTS, INC.
7307 GLOUCHESTER DR.
EDINA,  MN  55435
Applicant Contact JEFFREY R SHIDEMAN
Correspondent
INTERNATIONAL MEDICAL PRODUCTS, INC.
7307 GLOUCHESTER DR.
EDINA,  MN  55435
Correspondent Contact JEFFREY R SHIDEMAN
Regulation Number876.5820
Classification Product Code
KPO  
Date Received03/18/1998
Decision Date 06/16/1998
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
Recalls CDRH Recalls
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