FDA 510(k) Application Details - K031885

Device Classification Name	Holder, Head, Neurosurgical (Skull Clamp)   More FDA Info for this Device
510(K) Number	K031885
Device Name	Holder, Head, Neurosurgical (Skull Clamp)
Applicant	IMAGE-GUIDED NEUROLOGICS, INC. 2290 EAU GALLIE BLVD. MELBOURNE, FL 32935 US Other 510(k) Applications for this Company
Contact	DAVID M LEE 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	06/18/2003
Decision Date	08/21/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review