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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, single patient
510(k) Number K904967
Device Name HOSPAL BICART RETROFIT KIT NA/MONIT S GS HEMODIAL
Applicant
GAMBRO-HOSP-COBE, INC.
1185 OAK ST.
LAKEWOOD,  CO  80215
Applicant Contact JEFFREY SHIDEMAN
Correspondent
GAMBRO-HOSP-COBE, INC.
1185 OAK ST.
LAKEWOOD,  CO  80215
Correspondent Contact JEFFREY SHIDEMAN
Regulation Number876.5820
Classification Product Code
FKP  
Date Received11/05/1990
Decision Date 01/28/1991
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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