FDA 510(k) Application Details - K192162

Device Classification Name	Cover, Burr Hole   More FDA Info for this Device
510(K) Number	K192162
Device Name	Cover, Burr Hole
Applicant	NeuroVention LLC 645 S. Beach St. Daytona Beach, FL 32114 US Other 510(k) Applications for this Company
Contact	Rohit Khanna Other 510(k) Applications for this Contact
Regulation Number	882.5250   More FDA Info for this Regulation Number
Classification Product Code	GXR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/09/2019
Decision Date	03/13/2020
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