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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name injector and syringe, angiographic
510(k) Number K120892
Model C405-XXXX
Device Name DISPOSABLE 330PSI EXTENSION LINES
Original Applicant
COEUR, INC.
100 physicians way
suite 200
lebanon,  TN  37090
Original Contact debra f manning
Regulation Number870.1650
Classification Product Code
DXT  
Date Received03/23/2012
Decision Date 06/10/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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