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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 K811944
Device Name GAMBRO LUNDIA PLATE HIGH FLUX DIALYZER
Applicant
GAMBRO, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
GAMBRO, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.5860
Classification Product Code
KDI  
Date Received07/07/1981
Decision Date 08/31/1981
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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