FDA 510(k) Application Details - K191972

Device Classification Name	Plate, Fixation, Bone   More FDA Info for this Device
510(K) Number	K191972
Device Name	Plate, Fixation, Bone
Applicant	Jeil Medical Corporation 702,703,704,705,706,804,805,807,812,815-ho,55, Digital-ro 34-gil, Guro-gu Seoul 08378 KR Other 510(k) Applications for this Company
Contact	Ahhyeon Woo 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	07/24/2019
Decision Date	11/12/2019
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