FDA 510(k) Application Details - K113228

Device Classification Name	Neurological Stereotaxic Instrument   More FDA Info for this Device
510(K) Number	K113228
Device Name	Neurological Stereotaxic Instrument
Applicant	MAZOR ROBOTICS LTD 20 HATA'AS ST. KFAR SABA 44425 IL Other 510(k) Applications for this Company
Contact	AHAVA STEIN 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	11/01/2011
Decision Date	12/01/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review