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FDA 510(k) Application Details - K222146
Device Classification Name
More FDA Info for this Device
510(K) Number
K222146
Device Name
Disposable Endoscopic Hemoclip
Applicant
Jiangsu Vedkang Medical Science and Technology Co., Ltd.
No. 52, Guoxiang Road, Wujin Economic
Development Zone
Changzhou 213149 CN
Other 510(k) Applications for this Company
Contact
Lin Feng
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PKL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/20/2022
Decision Date
03/28/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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