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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nasopharyngoscope (Flexible Or Rigid)
510(k) Number K221581
Device Name Single-Use Flexible Rhinolaryngoscope
Applicant
Hunan Vathin Medical Instrument Co., Ltd.
1/F, Building 12, Innovation and Entrepreneurship Service
Ctr, No. 9 Chuanqi West Road Jiuhua Economic Dev. Zone
Xiangtan,  CN 411100
Applicant Contact Du Jing
Correspondent
Hunan Vathin Medical Instrument Co., Ltd.
1/F, Building 12, Innovation and Entrepreneurship Service
Ctr, No. 9 Chuanqi West Road Jiuhua Economic Dev. Zone
Xiangtan,  CN 411100
Correspondent Contact Du Jing
Regulation Number874.4760
Classification Product Code
EOB  
Date Received06/01/2022
Decision Date 11/18/2022
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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