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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 K142943
Device Name Metallic Locking Bone Plate and Screw
Applicant
Canwell Medical Co., Ltd.
#329 Yongkang St.
Jinhua,  CN 321015
Applicant Contact Chen Hui
Correspondent
Osmunda Medical Device Consulting Co., Ltd.
7th Floor Jingui Business Buildng # 982 Cogyuan Rd.
Baiyun District
Guangzhou,  CN 510420
Correspondent Contact Mike Gu
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received10/10/2014
Decision Date 08/03/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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