FDA 510(k) Application Details - K151248

Device Classification Name	Drill, Bone, Powered   More FDA Info for this Device
510(K) Number	K151248
Device Name	Drill, Bone, Powered
Applicant	MECTRON SPA VIA LORETO 15 CARASCO 16042 IT Other 510(k) Applications for this Company
Contact	MR. FRANCO ZUNINO 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	05/11/2015
Decision Date	09/04/2015
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