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FDA 510(k) Application Details - K190842
Device Classification Name
Plate, Fixation, Bone
More FDA Info for this Device
510(K) Number
K190842
Device Name
Plate, Fixation, Bone
Applicant
Jiangsu Trauhui Medical Instrument Co.,Ltd.
No.2 Longqing Road, Wujin Hi-Tech Industrial Zone
Changzhou 213168 CN
Other 510(k) Applications for this Company
Contact
Zhou Yu
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
04/01/2019
Decision Date
02/03/2020
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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