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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gas Control Unit, Cardiopulmonary Bypass
510(k) Number K965214
Device Name COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002)
Applicant
Coeur Laboratories, Inc.
5301 Depature Dr.
Raleigh,  NC  27604
Applicant Contact James M Clinton
Correspondent
Coeur Laboratories, Inc.
5301 Depature Dr.
Raleigh,  NC  27604
Correspondent Contact James M Clinton
Regulation Number870.4300
Classification Product Code
DTX  
Date Received12/30/1996
Decision Date 03/28/1997
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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