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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
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