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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 K251752
Device Name Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)
Applicant
Shanghai AnQing Medical Instrument Co., Ltd.
3 & 4 Floor, #2 Bldg., 366 Huiqing Rd.
East Zhangjiang High-Tech Park
Shanghai,  CN 201201
Applicant Contact Shuwen Fan
Correspondent
Shanghai AnQing Medical Instrument Co., Ltd.
3 & 4 Floor, #2 Bldg., 366 Huiqing Rd.
East Zhangjiang High-Tech Park
Shanghai,  CN 201201
Correspondent Contact Shuwen Fan
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received06/09/2025
Decision Date 08/27/2025
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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