FDA 510(k) Application Details - K182759

Device Classification Name	Plate, Bone   More FDA Info for this Device
510(K) Number	K182759
Device Name	Plate, Bone
Applicant	MontJade Engineering Co., Ltd. No.2-1, Gongyequ 7th Rd., Xitun Dist. Taichung City 40755 TW Other 510(k) Applications for this Company
Contact	Yu Sheng Lin Other 510(k) Applications for this Contact
Regulation Number	872.4760   More FDA Info for this Regulation Number
Classification Product Code	JEY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/2018
Decision Date	07/29/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review