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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
510(k) Number K232825
Device Name Disposable Sphincterotome
Applicant
Jiangsu Vedkang Medical Science and Technology Co., Ltd.
#52, Guoxiang Rd., Wujin Economic
Development Zone
Changzhou,  CN 213149
Applicant Contact Yulu Shi
Correspondent
Jiangsu Vedkang Medical Science and Technology Co., Ltd.
#52, Guoxiang Rd., Wujin Economic
Development Zone
Changzhou,  CN 213149
Correspondent Contact Yulu Shi
Regulation Number876.4300
Classification Product Code
KNS  
Date Received09/13/2023
Decision Date 03/29/2024
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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