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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 K171119
Device Name GM85
Applicant
Samsung Electronics Co.,Ltd.
129, Samsung-Ro, Yeongtong-Gu
Suwon-Si,  KR 16677
Applicant Contact Chulsin Kim
Correspondent
Samsung Electronics Co.,Ltd.
129, Samsung-Ro, Yeongtong-Gu
Suwon-Si,  KR 16677
Correspondent Contact Chulsin Kim
Regulation Number892.1720
Classification Product Code
IZL  
Subsequent Product Code
MQB  
Date Received04/14/2017
Decision Date 05/12/2017
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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