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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K200078
Device Name VARO Plan
Applicant
3D Industrial Imaging Co., Ltd.
Bldg. 138, Rm. 413, Seoul National University, 1 Gwanak-Ro
Seoul,  KR 08826
Applicant Contact Myungsuk Park
Correspondent
Wise Company, Inc.
#303, 142, Gasan Digital 1-Ro
Geumcheon-Gu,  KR 08507
Correspondent Contact Sanglok Lee
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/14/2020
Decision Date 04/10/2020
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
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