FDA 510(k) Application Details - K091439

Device Classification Name	Holder, Head, Neurosurgical (Skull Clamp)   More FDA Info for this Device
510(K) Number	K091439
Device Name	Holder, Head, Neurosurgical (Skull Clamp)
Applicant	SURGIVISION, INC. 11874 SOUTH EVELYN CIRCLE HOUSTON, TX 77071 US Other 510(k) Applications for this Company
Contact	J. HARVEY KNAUSS 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	05/14/2009
Decision Date	08/25/2009
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