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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 K140469
Device Name MR SYRINGE DUAL PACK
Applicant
Coeur, Inc.
100 Physicians Way
Suite 200
Lebanon,  TN  37090
Applicant Contact ERIN RHEINSCHELD
Correspondent
Coeur, Inc.
100 Physicians Way
Suite 200
Lebanon,  TN  37090
Correspondent Contact ERIN RHEINSCHELD
Regulation Number870.1650
Classification Product Code
DXT  
Date Received02/25/2014
Decision Date 07/28/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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