FDA 510(k) Application Details - K160363

Device Classification Name	Plate, Bone   More FDA Info for this Device
510(K) Number	K160363
Device Name	Plate, Bone
Applicant	OSTEONIC Co., Ltd. 1206ho, 38, Digital-ro 29-gil, Guro-gu Seoul KR Other 510(k) Applications for this Company
Contact	Jisun Lee 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	02/09/2016
Decision Date	10/20/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review