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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Irrigation/Suction System
510(k) Number K220785
Device Name Clean Connecting Tube
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
OCX  
Date Received03/17/2022
Decision Date 09/27/2022
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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