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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 K933818
Device Name GAMBRO POLYFLUX II HEMODIALYZERIALYZER HEMODIAFILTER
Applicant
C.G.H. MEDICAL, INC.
1185 OAK ST.
LAKEWOOD,  CO  80215
Applicant Contact JEFFREY R SHIDEMAN, PHD.
Correspondent
C.G.H. MEDICAL, INC.
1185 OAK ST.
LAKEWOOD,  CO  80215
Correspondent Contact JEFFREY R SHIDEMAN, PHD.
Regulation Number876.5860
Classification Product Code
KDI  
Date Received08/04/1993
Decision Date 01/25/1995
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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