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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Hematocrit, Automated
510(k) Number K904336
Device Name NEW COBE SATURATION/HEMATOCRIT MONITOR
Applicant
COBE LABORATORIES, INC.
14401 WEST 56TH WAY
ARVADA,  CO  80004
Applicant Contact MARY L ARMSTRONG
Correspondent
COBE LABORATORIES, INC.
14401 WEST 56TH WAY
ARVADA,  CO  80004
Correspondent Contact MARY L ARMSTRONG
Regulation Number864.5600
Classification Product Code
GKF  
Date Received09/20/1990
Decision Date 12/27/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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