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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 K896758
Device Name GAMBRO BICARBONATE MONITOR BCM 10-3
Applicant
Gambro, Inc.
460 Mclaws Cir.
Suite 200
Williamsburg,  VA  23185
Applicant Contact R SHIDEMAN
Correspondent
Gambro, Inc.
460 Mclaws Cir.
Suite 200
Williamsburg,  VA  23185
Correspondent Contact R SHIDEMAN
Regulation Number876.5820
Classification Product Code
FKP  
Date Received12/01/1989
Decision Date 09/28/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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