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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope Channel Accessory
510(k) Number K250732
Device Name Disposable Endoscopy Valve Set
Applicant
Yangzhou Fartley Medical Instrument Technology Co., Ltd.
Beizhou Rd.
Yangzhou,  CN 225106
Applicant Contact Xi Han
Correspondent
Yangzhou Fartley Medical Instrument Technology Co., Ltd.
Beizhou Rd.
Yangzhou,  CN 225106
Correspondent Contact Xi Han
Regulation Number876.1500
Classification Product Code
ODC  
Date Received03/11/2025
Decision Date 06/20/2025
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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