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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 K973253
Device Name ROCKWELL MEDICAL SUPPLY, LLC. CONCENTRATE SOLUTIONS FOR ACETATE DIALYSATE
Applicant
International Medical Products, Inc.
7307 Glouchester Dr.
Minneapolis,  MN  55435
Applicant Contact JEFFREY R SHIDEMAN
Correspondent
International Medical Products, Inc.
7307 Glouchester Dr.
Minneapolis,  MN  55435
Correspondent Contact JEFFREY R SHIDEMAN
Regulation Number876.5820
Classification Product Code
KPO  
Date Received08/29/1997
Decision Date 10/30/1997
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
Predetermined Change
Control Plan Authorized		 No
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