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C.G.H. Medical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
11
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K941708COBE CENTRYSYSTEM CS500 DIALYZERMay 12, 1995
K933818GAMBRO POLYFLUX II HEMODIALYZERIALYZER HEMODIAFILTERJanuary 25, 1995
K925522CENTRYSYSTEM 3 WITH CHARTS/BP OPTIONSeptember 30, 1994
K920757FILTRAL HEMODIALYZERSAugust 5, 1994
K931720LUNDIA ALPHA 700 HEMODIALYZERJuly 7, 1994
K924437HEMOSPAL KIT B22 / MULTIFLOW 60 KITJune 27, 1994
K940601GAMBRO BICART 720GMarch 22, 1994
K915154GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELSMay 27, 1992
K914271GAMBRO ENGSTROM Y-FILTER WITH EDITH FLEX (1500F)April 13, 1992
K915504GAMBRO LUNDIA ALPHA HEMODIALYZERSMarch 6, 1992
K911603HEMOSPAL KIT B22August 7, 1991