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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 K901473
Device Name GC-01 THROUGH GC-99 ACETATE CONCENTRATE
Applicant
GRANITE CHEMICAL CO., INC.
P.O. BOX 1504
MOUNT AIRY,  NC  27030
Applicant Contact J GRISWOLD
Correspondent
GRANITE CHEMICAL CO., INC.
P.O. BOX 1504
MOUNT AIRY,  NC  27030
Correspondent Contact J GRISWOLD
Regulation Number876.5820
Classification Product Code
KPO  
Date Received03/28/1990
Decision Date 07/27/1990
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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