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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 K191828
Device Name Vathin Video Bronchoscope System
Applicant
Hunan Vathin Medical Instrument Co., Ltd.
1/F, Building 12, No 9 Chuanqi west road,
Jiuhua Economic Development Zone
Xiangtan,  CN 411100
Applicant Contact Yun Feng
Correspondent
Guangzhou Osmunda Medical Device Technical Service Co., Ltd.
8-9th Floor, R&D Building, N0., 26 Qinglan Street,
Panyu District
Guangzhou,  CN 510006
Correspondent Contact Mike Gu
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received07/08/2019
Decision Date 02/13/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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