FDA 510(k) Application Details - K073061

Device Classification Name	Varnish, Cavity   More FDA Info for this Device
510(K) Number	K073061
Device Name	Varnish, Cavity
Applicant	COLL PARTNERS LTD. POB 6718 EFRAT 90435 IL Other 510(k) Applications for this Company
Contact	ELI M ORBACH Other 510(k) Applications for this Contact
Regulation Number	872.3260   More FDA Info for this Regulation Number
Classification Product Code	LBH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/30/2007
Decision Date	02/29/2008
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