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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
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