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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
Device Name DISPOSABLE 330PSI EXTENSION LINES
Applicant
COEUR, INC.
100 PHYSICIANS WAY
SUITE 200
LEBANON,  TN  37090
Applicant Contact DEBRA F MANNING
Correspondent
COEUR, INC.
100 PHYSICIANS WAY
SUITE 200
LEBANON,  TN  37090
Correspondent Contact DEBRA F MANNING
Regulation Number870.1650
Classification Product Code
DXT  
Date Received03/23/2012
Decision Date 06/10/2013
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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