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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 K896757
Device Name GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWS
Applicant
GAMBRO, INC.
460 MCLAWS CIRCLE, SUITE 200
WILLIAMSBURG,  VA  23185
Applicant Contact R SHIDEMAN
Correspondent
GAMBRO, INC.
460 MCLAWS CIRCLE, SUITE 200
WILLIAMSBURG,  VA  23185
Correspondent Contact R SHIDEMAN
Regulation Number876.5820
Classification Product Code
FKP  
Date Received12/01/1989
Decision Date 08/30/1990
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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