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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 K802389
Device Name GAMBRO LUNDIA PLATE DISP. 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 Number876.5820
Classification Product Code
FJG  
Date Received09/29/1980
Decision Date 12/22/1980
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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