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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 K864942
Device Name BICARBONATE MIXING SYSTEM
Applicant
Morris Tool , Ltd.
3922 N. Saginaw St.
Flint,  MI  48505
Applicant Contact CARY L NILES
Correspondent
Morris Tool , Ltd.
3922 N. Saginaw St.
Flint,  MI  48505
Correspondent Contact CARY L NILES
Regulation Number876.5820
Classification Product Code
KPO  
Date Received12/17/1986
Decision Date 03/10/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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