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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Display, Diagnostic Radiology
510(k) Number K141891
Device Name MEDICAL LCD MONITOR
Applicant
Kostec Co., Ltd.
2651 E. Chapman Ave., Suite 110
Fullerton,  CA  92831
Applicant Contact Priscilla Chung
Correspondent
Kostec Co., Ltd.
2651 E. Chapman Ave., Suite 110
Fullerton,  CA  92831
Correspondent Contact Priscilla Chung
Regulation Number892.2050
Classification Product Code
PGY  
Date Received07/14/2014
Decision Date 08/04/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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