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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 K211169
Device Name Bronchoscope System
Applicant
Shanghai AnQing Medical Instrument Co., Ltd.
3&4 Floor, # 2 Bldg., 366 Huiqing Rd., Zhangjiang
High-Tech Park
Shanghai,  CN 201201
Applicant Contact Shuwen Fan
Correspondent
Guangzhou Osmunda Medical Device Technical Service Co., Ltd.
9th Floor, R&D Bldg., # 26 Qinglan St.,
Panyu District
Guangzhou,  CN 510006
Correspondent Contact Shuwen Fan
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received04/19/2021
Decision Date 11/24/2021
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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