FDA 510(k) Application Details - K100836

Device Classification Name	More FDA Info for this Device
510(K) Number	K100836
Device Name	CLEARPOINT SYSTEM
Applicant	SURGIVISION, INC. COLUMBIA SQUARE 555 THIRTEENTH ST, NW WASHINGTON, DC 20004 US Other 510(k) Applications for this Company
Contact	JOHN J SMITH M.D., J.D. 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	03/24/2010
Decision Date	06/16/2010
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