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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 K982414
Device Name GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS
Applicant
GAMBRO HEALTHCARE
1185 OAK ST.
LAKEWOOD,  CO  80215 -4498
Applicant Contact JEFFREY R SHIDEMAN
Correspondent
GAMBRO HEALTHCARE
1185 OAK ST.
LAKEWOOD,  CO  80215 -4498
Correspondent Contact JEFFREY R SHIDEMAN
Regulation Number876.5860
Classification Product Code
KDI  
Date Received07/13/1998
Decision Date 03/26/1999
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
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