FDA 510(k) Application Details - K082470

Device Classification Name	Cleanser, Root Canal   More FDA Info for this Device
510(K) Number	K082470
Device Name	Cleanser, Root Canal
Applicant	INTER-MED, INC. 2200 NORTHWESTERN AVE. RACINE, WI 53404 US Other 510(k) Applications for this Company
Contact	GEORGE HORVAT Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	KJJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/27/2008
Decision Date	04/03/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review