FDA 510(k) Application Details - K111073

Device Classification Name	More FDA Info for this Device
510(K) Number	K111073
Device Name	SURGIVISION INC. CLEARPOINT SYSTEM
Applicant	SURGI-VISION, INC. 5 MUSICK IRVINE, CA 92618 US Other 510(k) Applications for this Company
Contact	EDWARD WADDELL Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	ORR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/18/2011
Decision Date	06/22/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review