FDA 510(k) Application Details - K080043

Device Classification Name	More FDA Info for this Device
510(K) Number	K080043
Device Name	VIZILITE EYEWEAR
Applicant	ZILA, INC. 5227 N. 7TH ST. PHOENIX, AZ 85014 US Other 510(k) Applications for this Company
Contact	MARK BRIDE Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	NXV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/08/2008
Decision Date	04/04/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review