FDA 510(k) Application Details - K991865

Device Classification Name	Activator, Ultraviolet, For Polymerization   More FDA Info for this Device
510(K) Number	K991865
Device Name	Activator, Ultraviolet, For Polymerization
Applicant	ROLENCE ENTERPRISE CO. LTD. 18-3 LANE 231 PU CHUNG RD. CHUNGLI TW Other 510(k) Applications for this Company
Contact	STERLING CHENG 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	06/01/1999
Decision Date	07/20/1999
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