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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K112558
Device Name DIGITAL FLAT PANEL X-RAY DETECTOR
Applicant
SAMSUNG MOBILE DISPLAY CO., LTD
12946 KIMBERLEY LANE
HOUSTON,  TX  77079
Applicant Contact DAVE KIM
Correspondent
SAMSUNG MOBILE DISPLAY CO., LTD
12946 KIMBERLEY LANE
HOUSTON,  TX  77079
Correspondent Contact DAVE KIM
Regulation Number892.1680
Classification Product Code
MQB  
Date Received09/02/2011
Decision Date 11/10/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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