FDA 510(k) Application Details - K111623

Device Classification Name	Controller, Foot, Handpiece And Cord   More FDA Info for this Device
510(K) Number	K111623
Device Name	Controller, Foot, Handpiece And Cord
Applicant	SATELEC-ACTEON GROUP 124 GAITHER DRIVE , SUITE 140 MT LAUREL, NJ 08054 US Other 510(k) Applications for this Company
Contact	RICK ROSATI Other 510(k) Applications for this Contact
Regulation Number	872.4200   More FDA Info for this Regulation Number
Classification Product Code	EBW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/10/2011
Decision Date	01/10/2012
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