FDA 510(k) Application Details - K071338

Device Classification Name	Retractor, Self-Retaining, For Neurosurgery   More FDA Info for this Device
510(K) Number	K071338
Device Name	Retractor, Self-Retaining, For Neurosurgery
Applicant	KOROS USA, INC. 610 FLINN AVE. MOORPARK, CA 93021 US Other 510(k) Applications for this Company
Contact	GABRIEL KOROS Other 510(k) Applications for this Contact
Regulation Number	882.4800   More FDA Info for this Regulation Number
Classification Product Code	GZT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/14/2007
Decision Date	05/29/2007
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	Y
Expedited Review