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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope (Flexible Or Rigid)
510(k) Number K223836
Device Name Vathin® Video Bronchoscope System
Applicant
Hunan Vathin Medical Instrument Co., Ltd.
1/F, Building 12, Innovation and Entrepreneurship Service
Center, No. 9 Chuanqi west road
Xiangtan,  CN 411100
Applicant Contact Du Jing
Correspondent
Hunan Vathin Medical Instrument Co., Ltd.
1/F, Building 12, Innovation and Entrepreneurship Service
Center, No. 9 Chuanqi west road
Xiangtan,  CN 411100
Correspondent Contact Du Jing
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received12/22/2022
Decision Date 05/15/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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