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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 K150009
Device Name Baide
Applicant
Jiangsu Baide Medical Intrument Co., Ltd.
South Side Of Dongqi Rd.
Zhangjiagang City,  CN 215627
Applicant Contact Mr.Kang Shui
Correspondent
Shanghai Yarui Consultant Co., Ltd.
503 Rm., 8 Bldg., 600 Liu Zhou Rd.
Shanghai,  CN 200233
Correspondent Contact Alice Gong
Regulation Number888.3030
Classification Product Code
HRS  
Date Received01/02/2015
Decision Date 02/25/2015
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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