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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope, Neurological
510(k) Number K222735
Device Name HJY VisualNext Endoscopic Vision System
Applicant
Hjy Smart Medical Device Co., Ltd.
12f., # 415, Sec. 4, Xinyi Dist.
Taipei City,  TW 11051
Applicant Contact John Jiannyuh Chen
Correspondent
Hjy Smart Medical Device Co., Ltd.
12f., # 415, Sec. 4, Xinyi Dist.
Taipei City,  TW 11051
Correspondent Contact John Jiannyuh Chen
Regulation Number882.1480
Classification Product Code
GWG  
Date Received09/09/2022
Decision Date 07/28/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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