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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 K150097
Device Name GM60A-32S & GM60A-40S
Applicant
SAMSUNG ELECTRONICS CO., LTD.
129, SAMSUNG-RO
YEONGTONG-GU
SUWON-SI,  KR 443742
Applicant Contact CHULSIN KIM
Correspondent
SAMSUNG ELECTRONICS CO., LTD.
129, SAMSUNG-RO
YEONGTONG-GU
SUWON-SI,  KR 443742
Correspondent Contact CHULSIN KIM
Regulation Number892.1720
Classification Product Code
IZL  
Date Received01/20/2015
Decision Date 02/19/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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