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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K200548
Device Name CUBEScan BioCon-1100
Applicant
Mcube Technology Co., Ltd.
#803, 123, Bonghwasan-Ro
Jungnang-Gu, Seoul, Korea
Seoul,  KR 02048
Applicant Contact Hye-Ri Choi
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact DAVE YUNGVIRT
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received03/03/2020
Decision Date 03/27/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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