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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 K030592
Device Name GAMBRO POLYFLUX, MODEL 140H, 170H, 210H
Applicant
GAMBRO RENAL CARE PRODUCTS
10810 W. COLLINS AVE.
LAKEWOOD,  CO  80215
Applicant Contact JEFFREY R SCHIDMAN
Correspondent
GAMBRO RENAL CARE PRODUCTS
10810 W. COLLINS AVE.
LAKEWOOD,  CO  80215
Correspondent Contact JEFFREY R SCHIDMAN
Regulation Number876.5860
Classification Product Code
KDI  
Date Received02/25/2003
Decision Date 05/23/2003
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
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