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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 K232442
Device Name Disposable Endoscope Injection Needles
Applicant
Zhejiang Soudon Medical Technology Co.,Ltd
Room 302-1, Floor 3, Building 4, No.1 Nangonghe Road,
Donghu Street, Linping District
Hangzhou,  CN 311100
Applicant Contact Junshi Wang
Correspondent
Shanghai Vanhe Consulting Co., Ltd
2F, Building No.1, 3938 Huqingping Road, Qingpu District
Shanghai,  CN 201703
Correspondent Contact Nick Wang
Regulation Number876.1500
Classification Product Code
FBK  
Date Received08/14/2023
Decision Date 11/09/2023
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
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