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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gastroscope And Accessories, Flexible/Rigid
510(k) Number K242635
Device Name Endoscopic Distal Attachment (AF-D 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 Song Wei
Regulation Number876.1500
Classification Product Code
FDS  
Subsequent Product Code
FDF  
Date Received09/03/2024
Decision Date 05/30/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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