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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, continuous flush
510(K) Number K122796
Model CXI (PRODUCT PREFIX)
Device Name CXI SUPPORT CATHETER
Applicant
COOK, INC.
750 daniels way
blmgtn,  IN  47404
Contact molly busenbark
Regulation Number870.1210
Classification Product Code
KRA  
Date Received09/12/2012
Decision Date 10/11/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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