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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 K212668
Device Name Sclerotherapy Needle
Applicant
Zhejiang Chuangxiang Medical Technology Co., Ltd.
Hangzhou,  CN 311100
Applicant Contact Lucius Long
Correspondent
Zhejiang Chuangxiang Medical Technology Co., Ltd.
Bldg. 50, # 650 Hongfeng Rd. Donghu St.
Yuhang District
Hangzhou,  CN 311100
Correspondent Contact Lucius Long
Regulation Number876.1500
Classification Product Code
FBK  
Date Received08/23/2021
Decision Date 02/23/2022
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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