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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 K940601
Device Name GAMBRO BICART 720G
Applicant
C.G.H. MEDICAL, INC.
1185 OAK ST.
LAKEWOOD,  CO  80215
Applicant Contact JEFFREY R SHIDEMAN
Correspondent
C.G.H. MEDICAL, INC.
1185 OAK ST.
LAKEWOOD,  CO  80215
Correspondent Contact JEFFREY R SHIDEMAN
Regulation Number876.5820
Classification Product Code
KPO  
Date Received02/10/1994
Decision Date 03/22/1994
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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