FDA 510(k) Application Details - K141950

Device Classification Name	Holder, Head, Neurosurgical (Skull Clamp)   More FDA Info for this Device
510(K) Number	K141950
Device Name	Holder, Head, Neurosurgical (Skull Clamp)
Applicant	IMRIS, INC. 5101 Shady Oak Rd Minnetonka, MN 55343 US Other 510(k) Applications for this Company
Contact	KARISSA HOLCOMB 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	07/18/2014
Decision Date	09/04/2014
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