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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Injection Needle, Gastroenterology-Urology
510(k) Number K220292
Device Name Disposable Endoscope Injection Needle
Applicant
Yangzhou Fartley Medical Instrument Technology Co., Ltd.
Beizhou Road, Lidian Town, Guangling District
Yangzhou,  CN 225106
Applicant Contact Tina Han
Correspondent
Shanghai Thinkwell Consulting Co., Ltd
Room 211/6F, Xinling Road, Minhang District
Shanghai,  CN 201100
Correspondent Contact Ethan Liu
Regulation Number876.1500
Classification Product Code
FBK  
Date Received02/01/2022
Decision Date 08/19/2022
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
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