FDA 510(k) Application Details - K023652

Device Classification Name	Activator, Ultraviolet, For Polymerization   More FDA Info for this Device
510(K) Number	K023652
Device Name	Activator, Ultraviolet, For Polymerization
Applicant	REMEDENT NV 20992 BAKE PKWY. UNIT 102 LAKE FOREST, CA 92692 US Other 510(k) Applications for this Company
Contact	ED FIRST 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	10/30/2002
Decision Date	01/09/2003
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