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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 K863631
Device Name SODIUM BICARBONATE POWDER/BICARBONATE HEMODIALYSIS
Applicant
AMERICAN HEALTHCARE CORP.
825 HILLSIDE CT.
LONGMONT,  CO  80501
Applicant Contact JIM WELSCH
Correspondent
AMERICAN HEALTHCARE CORP.
825 HILLSIDE CT.
LONGMONT,  CO  80501
Correspondent Contact JIM WELSCH
Regulation Number876.5820
Classification Product Code
KPO  
Date Received09/17/1986
Decision Date 10/16/1986
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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