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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dialyzer, Parallel Flow
510(k) Number K853406
Device Name GAMBRO LUNDIA PRO 3 & 5 DIALYZER
Applicant
GAMBRO, INC.
600 KNIGHTSBRIDGE PKWY.
LINCOLNSHIRE,  IL  60069
Applicant Contact JEFFREY R SHIDEMAN
Correspondent
GAMBRO, INC.
600 KNIGHTSBRIDGE PKWY.
LINCOLNSHIRE,  IL  60069
Correspondent Contact JEFFREY R SHIDEMAN
Regulation Number876.5820
Classification Product Code
FJG  
Date Received08/12/1985
Decision Date 01/08/1986
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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