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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemodialyzer, Re-Use, High Flux
510(k) Number K023615
Device Name GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR
Applicant
GAMBRO RENAL PRODUCTS
10810 W. COLLINS AVE.
LAKEWOOD,  CO  80215
Applicant Contact JEFFREY R SHIDEMAN
Correspondent
GAMBRO RENAL PRODUCTS
10810 W. COLLINS AVE.
LAKEWOOD,  CO  80215
Correspondent Contact JEFFREY R SHIDEMAN
Regulation Number876.5860
Classification Product Code
MSF  
Date Received10/28/2002
Decision Date 05/06/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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