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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dialyzer, high permeability with or without sealed dialysate system
510(k) Number K854309
Device Name GAMBRO BLOOD CONCENTRATOR SETS 16,60,200
Applicant
GAMBRO, INC.
600 KNIGHTSBRIDGE PKWY.
LINCOLNSHIRE,  IL  60069
Applicant Contact JEFFREY SHIDEMAN
Correspondent
GAMBRO, INC.
600 KNIGHTSBRIDGE PKWY.
LINCOLNSHIRE,  IL  60069
Correspondent Contact JEFFREY SHIDEMAN
Regulation Number876.5860
Classification Product Code
KDI  
Date Received10/25/1985
Decision Date 12/13/1985
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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