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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 K231642
Device Name Veuron-Brain-pAb3
Applicant
Heuron Co., Ltd.
10f, C, 150, Yeongdeungpo-Ro, Yeongdeungpo-Gu
Seoul,  KR 07292
Applicant Contact Lee Hae Ri
Correspondent
Hogan Lovells US LLP
Columbia Square
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact John J. Smith
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/05/2023
Decision Date 10/13/2023
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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