FDA 510(k) Application Details - K181539

Device Classification Name	Cover, Burr Hole   More FDA Info for this Device
510(K) Number	K181539
Device Name	Cover, Burr Hole
Applicant	OssDsign AB Virdings Alle 2 Uppsala SE 754 50 SE Other 510(k) Applications for this Company
Contact	Ulrik Birgersson 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	06/11/2018
Decision Date	10/12/2018
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