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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope Accessory
510(k) Number K241679
Device Name Disposable Cytology Brush (AF series)
Applicant
Alton (Shanghai) Medical Instruments Co., Ltd.
#24 Bldg. Jinshao Rd. 1688.Baoshan District.
Shanghai,  CN 200949
Applicant Contact Vivian Li
Correspondent
Alton (Shanghai) Medical Instruments Co., Ltd.
#24 Bldg. Jinshao Rd. 1688.Baoshan District.
Shanghai,  CN 200949
Correspondent Contact Wei Song
Regulation Number874.4680
Classification Product Code
KTI  
Subsequent Product Code
FDX  
Date Received06/11/2024
Decision Date 03/04/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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