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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemostatic Metal Clip For The Gi Tract
510(k) Number K230004
Device Name Disposable Hemoclip
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 Number876.4400
Classification Product Code
PKL  
Date Received01/03/2023
Decision Date 07/31/2023
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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