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FDA 510(k) Application Details - K143002
Device Classification Name
Plate, Fixation, Bone
More FDA Info for this Device
510(K) Number
K143002
Device Name
Plate, Fixation, Bone
Applicant
Changzhou Dingjian Medical Appliance Co., Ltd
No.19 Juxiang Road, Wujin Economic Development Zone
Changzhou 213149 CN
Other 510(k) Applications for this Company
Contact
Li Qingsong
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
HRS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/20/2014
Decision Date
06/05/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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