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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 K190842
Device Name Comus Locking Plate systems
Applicant
Jiangsu Trauhui Medical Instrument Co., Ltd.
#2 Longqing Rd., Wujin Hi-Tech Industrial Zone
Changzhou,  CN 213168
Applicant Contact Zhou Yu
Correspondent
Guangzhou Osmunda Medical Device Consulting Co., Ltd.
8-9th Floor, R&D Bldg., #26 Qinglan St., Panyu
District
Guangzhou,  CN 510006
Correspondent Contact Mike Gu
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received04/01/2019
Decision Date 02/03/2020
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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