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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Ultrasonic Surgical
510(k) Number K233036
Device Name Ultrasonic Surgical System
Applicant
Hunan Handlike Minimally Invasive Surgery Co., Ltd.
A4, Lugu Yuyuan, #27, Wenxuan Rd., High-Tech Zone
Changsha,  CN 410205
Applicant Contact Yang Bihong
Correspondent
Share Info (Guangzhou) Medical Consultant , Ltd.
# 1919-1920, Bldg. D3, Minjie Plaza, Shuixi Rd.,
Huangpu District
Guangzhou,  CN 510700
Correspondent Contact Lee Cassie
Classification Product Code
LFL  
Date Received09/25/2023
Decision Date 06/18/2024
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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