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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, intravascular, diagnostic
510(k) Number K063784
Device Name DYE MANAGEMENT SYSTEM
Original Applicant
ICU MEDICAL, INC
4455 atherton dr.
salt lake city,  UT  84123
Original Contact martin maier
Regulation Number870.1200
Classification Product Code
DQO  
Date Received12/21/2006
Decision Date 04/16/2007
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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