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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 K203142
Device Name Veuron-Brain-pAb
Applicant
Heuron Co., Ltd.
10th Floor, 7, Mirae-Ro, Namdong-Gu
Incheon,  KR 21558
Applicant Contact Dong Hoon Shin
Correspondent
Lighten Bridge, LLC
4408 Tortuga Ln
Mckinney,  TX  75070
Correspondent Contact Edward Park
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/20/2020
Decision Date 01/15/2021
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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