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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 K250232
Device Name Vathin® Video Bronchoscope System
Applicant
Hunan Vathin Medical Instrument Co., Ltd.
1/F, Bldg.12, Innovation And Entrepreneurship Service Cen
Ter, # 9 Chuanqi W. Rd., Jiuhua Economic Development Zo
Xiang Tan,  CN 411100
Applicant Contact Jing Du
Correspondent
Hunan Vathin Medical Instrument Co., Ltd.
1/F, Bldg.12, Innovation And Entrepreneurship Service Cen
Ter, # 9 Chuanqi W. Rd., Jiuhua Economic Development Zo
Xiang Tan,  CN 411100
Correspondent Contact Jing Du
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received01/27/2025
Decision Date 07/25/2025
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
Predetermined Change
Control Plan Authorized		 No
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