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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 K060195
Device Name GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USE
Applicant
GAMBRO RENAL PRODUCTS
10810 WEST COLLINS AVE.
LAKEWOOD,  CO  80215
Applicant Contact THOMAS B DOWELL
Correspondent
GAMBRO RENAL PRODUCTS
10810 WEST COLLINS AVE.
LAKEWOOD,  CO  80215
Correspondent Contact THOMAS B DOWELL
Regulation Number876.5860
Classification Product Code
KDI  
Date Received01/25/2006
Decision Date 04/24/2006
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
Recalls CDRH Recalls
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