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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.
No.2 Longqing Road, 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 Building, No.26 Qinglan Street
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
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