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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
Predetermined Change
Control Plan Authorized		 No
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