FDA 510(k) Application Details - K080113

Device Classification Name	Locator, Root Apex   More FDA Info for this Device
510(K) Number	K080113
Device Name	Locator, Root Apex
Applicant	MEDICNRG LTD. 291 HILLSIDE AVE. SOMERSET, MA 02726 US Other 510(k) Applications for this Company
Contact	GEORGE J HATTUB Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LQY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/16/2008
Decision Date	02/15/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review