FDA 510(k) Application Details - K132044

Device Classification Name	Cover, Burr Hole   More FDA Info for this Device
510(K) Number	K132044
Device Name	Cover, Burr Hole
Applicant	NEOS SURGERY S.L. 901 KING STREET SUITE 101 ALEXANDRIA, VA 22314 US Other 510(k) Applications for this Company
Contact	CHERITA JAMES 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	07/02/2013
Decision Date	09/30/2013
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