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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 K890292
Device Name PCA-10, 10CC DISP. ANGIOGRAPHY CONTROL SYRINGE
Applicant
Coeur Laboratories, Inc.
5301 Depature Dr.
Raleigh,  NC  27604
Applicant Contact TERESA R MCCLEERY
Correspondent
Coeur Laboratories, Inc.
5301 Depature Dr.
Raleigh,  NC  27604
Correspondent Contact TERESA R MCCLEERY
Regulation Number870.1650
Classification Product Code
DXT  
Date Received01/19/1989
Decision Date 06/22/1989
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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