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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 K823920
Device Name COEURLOCK STERILE DISPOS. ANGIOGRAPHIC
Applicant
Coeur Laboratories, Inc.
NC 
Correspondent
Coeur Laboratories, Inc.
NC 
Regulation Number870.1650
Classification Product Code
DXT  
Date Received12/28/1982
Decision Date 02/18/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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