FDA 510(k) Application Details - K142943

Device Classification Name	Plate, Fixation, Bone   More FDA Info for this Device
510(K) Number	K142943
Device Name	Plate, Fixation, Bone
Applicant	Canwell Medical Co., Ltd No.329 Yongkang Street Jinhua 321015 CN Other 510(k) Applications for this Company
Contact	Chen Hui 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	10/10/2014
Decision Date	08/03/2015
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