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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name set, administration, intravascular
510(k) Number K100434
Device Name CLAVE NEUTRON
Original Applicant
ICU MEDICAL, INC.
4455 atherton drive
salt lake city,  UT  84123
Original Contact tracy best
Regulation Number880.5440
Classification Product Code
FPA  
Subsequent Product Code
KGZ  
Date Received02/16/2010
Decision Date 07/09/2010
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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