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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 K161471
Device Name MR Syringe Dual Pack for Solaris Injectors
Applicant
Coeur, Inc.
100 Physicians Way
Lebanon,  TN  37090
Applicant Contact Priscilla Clinner
Correspondent
Coeur, Inc.
100 Physicians Way
Lebanon,  TN  37090
Correspondent Contact Priscilla Clinner
Regulation Number870.1650
Classification Product Code
DXT  
Date Received05/27/2016
Decision Date 10/06/2016
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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