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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, Mobile
510(k) Number K142492
Device Name GM60A-32S, GM60A-40S
Applicant
Samsung Electronics Co., Ltd.
129, Samsung-Ro
Yeongtong-Gu
Suwon-Si, Gyeonggi-Do,  KR 443742
Applicant Contact KIM CHULSIN
Correspondent
Samsung Electronics Co., Ltd.
129, Samsung-Ro
Yeongtong-Gu
Suwon-Si, Gyeonggi-Do,  KR 443742
Correspondent Contact KIM CHULSIN
Regulation Number892.1720
Classification Product Code
IZL  
Date Received09/04/2014
Decision Date 12/17/2014
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
Recalls CDRH Recalls
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