FDA 510(k) Application Details - K160523

Device Classification Name	Neurological Stereotaxic Instrument   More FDA Info for this Device
510(K) Number	K160523
Device Name	Neurological Stereotaxic Instrument
Applicant	SYNAPTIVE MEDICAL INC. MARS CENTER, SOUTH TOWER, 101 COLLEGE STREET, SUITE 200 TORONTO M5G 1L7 CA Other 510(k) Applications for this Company
Contact	Cameron Piron 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	02/25/2016
Decision Date	06/24/2016
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