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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 K151057
Device Name WASTON Metallic Bone Plate and Screw Systems
Applicant
Changzhou Waston Medical Appliance Co., Ltd.
9 Xihu Rd., Wujin Hi-Tech Industry Zone
Changzhou,  CN 213168
Applicant Contact Jack Lu
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received04/20/2015
Decision Date 08/10/2015
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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