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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K912829
Device Name CARDIOTRACE CARDIAC EVALUATION SYSTEMS
Applicant
Cine Graphics, Inc.
933 Egyptian Way
Grand Prairie,  TX  75050
Applicant Contact JOHN JENKINS
Correspondent
Cine Graphics, Inc.
933 Egyptian Way
Grand Prairie,  TX  75050
Correspondent Contact JOHN JENKINS
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/26/1991
Decision Date 09/24/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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