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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 K032920
Device Name THE COEUR INJECTOR ADAPTOR/PRESSURE JACKET, MODEL C859-6003
Applicant
Coeur Medical
209 Creekside Dr.
Washington,  NC  27889
Applicant Contact DEBRA F MANNING
Correspondent
Coeur Medical
209 Creekside Dr.
Washington,  NC  27889
Correspondent Contact DEBRA F MANNING
Regulation Number870.1650
Classification Product Code
DXT  
Date Received09/22/2003
Decision Date 12/16/2003
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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