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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 K971053
Device Name ROCKWELL MEDICAL SUPPLY,LLC. BICARBONATE SOLUTION CONCENTRATES FOR BICARBONATE DIALYSIS
Applicant
International Medical Products, Inc.
4503 Moorland Ave.
Minneapolis,  MN  55435
Applicant Contact JEFFREY R SHIDEMAN
Correspondent
International Medical Products, Inc.
4503 Moorland Ave.
Minneapolis,  MN  55435
Correspondent Contact JEFFREY R SHIDEMAN
Regulation Number876.5820
Classification Product Code
KPO  
Date Received03/24/1997
Decision Date 06/16/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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