FDA 510(k) Application Details - K112188

Device Classification Name	Drill, Bone, Powered   More FDA Info for this Device
510(K) Number	K112188
Device Name	Drill, Bone, Powered
Applicant	SATELEC - ACTEON, INC. 124 GAITHER DR., SUITE 140 MOUNT LAUREL, NJ 08054 US Other 510(k) Applications for this Company
Contact	RICK ROSATI Other 510(k) Applications for this Contact
Regulation Number	872.4120   More FDA Info for this Regulation Number
Classification Product Code	DZI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/29/2011
Decision Date	02/03/2012
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