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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.
No.52, Guoxiang Road, Wujin Economic
Development Zone
Changzhou,  CN 213149
Applicant Contact Yulu Shi
Correspondent
Jiangsu Vedkang Medical Science and Technology Co., Ltd.
No.52, Guoxiang Road, 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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