FDA 510(k) Application Details - K152342

Device Classification Name	Cover, Burr Hole   More FDA Info for this Device
510(K) Number	K152342
Device Name	Cover, Burr Hole
Applicant	ST. JUDE MEDICAL 6901 PRESTON ROAD PLANO, TX 75024 US Other 510(k) Applications for this Company
Contact	PARITA MEHTA 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	08/19/2015
Decision Date	06/09/2016
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