FDA 510(k) Application Details - K190811

Device Classification Name	Plate, Cranioplasty, Preformed, Alterable   More FDA Info for this Device
510(K) Number	K190811
Device Name	Plate, Cranioplasty, Preformed, Alterable
Applicant	Osteonic Co., Ltd 505-3Ho, 1206Ho, 38, Digital-ro 29-gil, Guro-gu Seoul 08381 KR Other 510(k) Applications for this Company
Contact	Choi Se Young Other 510(k) Applications for this Contact
Regulation Number	882.5320   More FDA Info for this Regulation Number
Classification Product Code	GWO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/29/2019
Decision Date	11/27/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review