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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Stationary
510(k) Number K143029
Device Name Digital Diagnostic X-ray System (GC80)
Applicant
Samsung Electronics Co., Ltd.
129, Samsung-Ro
Yeongtong-Gu
Suwon-Si,  KR 443742
Applicant Contact KIM CHULSIN
Correspondent
Samsung Electronics Co., Ltd.
129, Samsung-Ro
Yeongtong-Gu
Suwon-Si,  KR 443742
Correspondent Contact KIM CHULSIN
Regulation Number892.1680
Classification Product Code
KPR  
Date Received10/21/2014
Decision Date 02/04/2015
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
Recalls CDRH Recalls
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