FDA 510(k) Application Details - K060973

Device Classification Name	Retractor, Self-Retaining, For Neurosurgery   More FDA Info for this Device
510(K) Number	K060973
Device Name	Retractor, Self-Retaining, For Neurosurgery
Applicant	VYCOR MEDICAL LLC 543 LONG HILL AVENUE SHELTON, CT 06484 US Other 510(k) Applications for this Company
Contact	JOSEPH AZARY 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	04/10/2006
Decision Date	07/26/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review