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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, dialysate delivery, central multiple patient
510(k) Number K843963
Device Name DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD
Applicant
RENAL SYSTEMS, INC.
14905 28TH AVE. N.
MINNEAPOLIS,  MN  55441
Applicant Contact LEROY J FISCHBACH
Correspondent
RENAL SYSTEMS, INC.
14905 28TH AVE. N.
MINNEAPOLIS,  MN  55441
Correspondent Contact LEROY J FISCHBACH
Regulation Number876.5820
Classification Product Code
FKQ  
Date Received10/11/1984
Decision Date 01/07/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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