FDA 510(k) Application Details - K063003

Device Classification Name	Activator, Ultraviolet, For Polymerization   More FDA Info for this Device
510(K) Number	K063003
Device Name	Activator, Ultraviolet, For Polymerization
Applicant	PARKELL, INC. 300 EXECUTIVE DR. EDGEWOOD, NY 11717 US Other 510(k) Applications for this Company
Contact	DANIEL R SCHECHTER 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	10/02/2006
Decision Date	11/28/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review