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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 K151508
Device Name IRENE Locking Compression Plate System
Applicant
Tianjin Zhengtian Medical Instrument Co., Ltd.
#318, Jingyi Rd., Airport Economic Zone
Tianjin,  CN 300308
Applicant Contact YIFAN FU
Correspondent
Tianjin Zhengtian Medical Instrument Co., Ltd.
#318, Jingyi Rd., Airport Economic Zone
Tianjin,  CN 300308
Correspondent Contact YIFAN FU
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received06/04/2015
Decision Date 02/25/2016
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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