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510(k) K242922

Extracorporeal Shock Wave Lithotripter (U200) by Shenzhen Wikkon Precision Technologies Co., Ltd. — Product Code LNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2025
Date Received
September 24, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lithotriptor, Extracorporeal Shock-Wave, Urological
Device Class
Class II
Regulation Number
876.5990
Review Panel
GU
Submission Type

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