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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name apparatus, hemoperfusion, sorbent
510(k) Number K873643
Device Name GAMBRO ADSORBA 150C
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 Number876.5870
Classification Product Code
FLD  
Date Received09/09/1987
Decision Date 12/29/1987
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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