FDA 510(k) Application Details - K063468

Device Classification Name	Unit, Electrosurgical, And Accessories, Dental   More FDA Info for this Device
510(K) Number	K063468
Device Name	Unit, Electrosurgical, And Accessories, Dental
Applicant	MEDISURG LTD. 100 WEST FORNANCE ST. THE FUGO BUILDING NORRISTOWN, PA 19401 US Other 510(k) Applications for this Company
Contact	RICHARD J FUGO Other 510(k) Applications for this Contact
Regulation Number	872.4920   More FDA Info for this Regulation Number
Classification Product Code	EKZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/16/2006
Decision Date	04/18/2007
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