FDA 510(k) Application Details - K032917

Device Classification Name	Neurological Stereotaxic Instrument   More FDA Info for this Device
510(K) Number	K032917
Device Name	Neurological Stereotaxic Instrument
Applicant	ORTHOSOFT, INC. 75 QUEEN ST., SUITE 3300 MONTREAL, QUEBEC H3C 2N6 CA Other 510(k) Applications for this Company
Contact	CHRISTOPHER MCLEAN 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	09/22/2003
Decision Date	10/21/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review