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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name introducer, catheter
510(k) Number K123235
Model MIC (PRODUCT PREFIX)
Device Name EQUAFLOW MULTIVALVE INFUSION CATHETER
Original Applicant
COOK INCORPORATED
750 daniels way
bloomington,  IN  47404
Original Contact amber brown
Regulation Number870.1340
Classification Product Code
DYB  
Date Received10/16/2012
Decision Date 02/14/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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