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510(k) K232476

Disposable Sphincterotome by Zhejiang Soudon Medical Technology Co., Ltd. — Product Code KNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 2023
Date Received
August 16, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type

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