FDA 510(k) Application Details - K071482

Device Classification Name	Generator, Lesion, Radiofrequency   More FDA Info for this Device
510(K) Number	K071482
Device Name	Generator, Lesion, Radiofrequency
Applicant	SYNERGETICS, INC 3845 CORPORATE CENTRE DRIVE O'FALLON, MO 63368 US Other 510(k) Applications for this Company
Contact	DAN REGAN Other 510(k) Applications for this Contact
Regulation Number	882.4400   More FDA Info for this Regulation Number
Classification Product Code	GXD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/30/2007
Decision Date	12/20/2007
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	N
Expedited Review