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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name wire, guide, catheter
510(k) Number K113498
Device Name DISPOSABLE TORQUE DEVICE
Original Applicant
COEUR, INC.
100 physicians way
suite 200
lebanon,  TN  37090
Original Contact debra f manning
Regulation Number870.1330
Classification Product Code
DQX  
Date Received11/25/2011
Decision Date 07/20/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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