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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 K140235
Device Name XGEO GR40CW
Applicant
SAMSUNG ELECTRONICS CO., LTD.
129, SAMSUNG-RO
YEONGTONG-GU
SUWON-SI, GYEONGGI-DO,  KR 443742
Applicant Contact JEONGPYO HONG
Correspondent
SAMSUNG ELECTRONICS CO., LTD.
129, SAMSUNG-RO
YEONGTONG-GU
SUWON-SI, GYEONGGI-DO,  KR 443742
Correspondent Contact JEONGPYO HONG
Regulation Number892.1680
Classification Product Code
MQB  
Date Received01/30/2014
Decision Date 05/15/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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