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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 K220210
Device Name Disposable Endoscopy Adapter Set
Applicant
Yangzhou Fartley Medical Instrument Technology Co., Ltd.
Beizhou Rd., Lidian Town, Guangling District
Yangzhou,  CN 225106
Applicant Contact Tina Han
Correspondent
Shanghai Thinkwell Consulting Co., Ltd.
Rm. 211/6f, Xinling Rd., Minhang District
Shanghai,  CN 201100
Correspondent Contact Ethan Liu
Regulation Number876.1500
Classification Product Code
ODC  
Date Received01/26/2022
Decision Date 06/17/2022
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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