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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Display, Cathode-Ray Tube, Medical
510(k) Number K053356
Device Name MODIFICATION TO: CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION
Applicant
Ge Medical Systems Information Technologies
8200 W. Tower Ave.
Milwaukee,  WI  53223
Applicant Contact RONALD N BLASKI
Correspondent
Ge Medical Systems Information Technologies
8200 W. Tower Ave.
Milwaukee,  WI  53223
Correspondent Contact RONALD N BLASKI
Regulation Number870.2450
Classification Product Code
DXJ  
Date Received12/02/2005
Decision Date 04/19/2006
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
Recalls CDRH Recalls
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