FDA 510(k) Application Details - K113748

Device Classification Name	Holder, Head, Neurosurgical (Skull Clamp)   More FDA Info for this Device
510(K) Number	K113748
Device Name	Holder, Head, Neurosurgical (Skull Clamp)
Applicant	IMRIS, INC. 100-1370 SONY PLACE WINNIPEG, MB R3T 1N5 CA Other 510(k) Applications for this Company
Contact	Sanjay Shah Other 510(k) Applications for this Contact
Regulation Number	882.4460   More FDA Info for this Regulation Number
Classification Product Code	HBL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/21/2011
Decision Date	03/23/2012
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