FDA 510(k) Application Details - K010542

Device Classification Name	Neurological Stereotaxic Instrument   More FDA Info for this Device
510(K) Number	K010542
Device Name	Neurological Stereotaxic Instrument
Applicant	SURGICAL NAVIGATION SPECIALISTS, INC. 6509 AIRPORT ROAD MISSISSAUGA ONTARIO L4V 1S7 CA Other 510(k) Applications for this Company
Contact	CAROL NAKAGAWA Other 510(k) Applications for this Contact
Regulation Number	882.4560   More FDA Info for this Regulation Number
Classification Product Code	HAW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/23/2001
Decision Date	05/08/2001
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