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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K242973
Device Name CanMINI Hand and Foot System
Applicant
Canwell Medical Co., Ltd.
#466 S. Xianhua St.,High-Tech Industrial Zone
Jinhua,  CN 321016
Applicant Contact Hui Chen
Correspondent
Shanghai Lingfu Technology Co., Ltd.
Rm. 1115, Block A, Xuhui Vanke Centre, # 55 Ding'An Rd.,
Xuhui District
Shanghai,  CN 200030
Correspondent Contact Jiangfeng Ren
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received09/26/2024
Decision Date 04/24/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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