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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dialyzer, Capillary, Hollow Fiber
510(k) Number K880084
Device Name GF 120M, 120H, 180M & 180H HOLLOW FIBER DIALYZERS
Applicant
GAMBRO, INC.
600 KNIGHTSBRIDGE PKWY.
LINCOLNSHIRE,  IL  60069
Applicant Contact JEFFREY SHIDEMAN,PHD
Correspondent
GAMBRO, INC.
600 KNIGHTSBRIDGE PKWY.
LINCOLNSHIRE,  IL  60069
Correspondent Contact JEFFREY SHIDEMAN,PHD
Regulation Number876.5820
Classification Product Code
FJI  
Date Received01/12/1988
Decision Date 02/19/1988
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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