FDA 510(k) Application Details - K033795

Device Classification Name	Activator, Ultraviolet, For Polymerization   More FDA Info for this Device
510(K) Number	K033795
Device Name	Activator, Ultraviolet, For Polymerization
Applicant	EELE LABORATORIES, LLC 50 ORVILLE DRIVE BOHEMIA, NY 11716 US Other 510(k) Applications for this Company
Contact	ROBERT GRASMAN Other 510(k) Applications for this Contact
Regulation Number	872.6070   More FDA Info for this Regulation Number
Classification Product Code	EBZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/05/2003
Decision Date	12/19/2003
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	Y
Expedited Review