FDA 510(k) Application Details - K140965

Device Classification Name	Scaler, Ultrasonic   More FDA Info for this Device
510(K) Number	K140965
Device Name	Scaler, Ultrasonic
Applicant	MECTRON SPA PIAZZA ALBANIA, 10 ROME 00153 IT Other 510(k) Applications for this Company
Contact	ROGER GRAY Other 510(k) Applications for this Contact
Regulation Number	872.4850   More FDA Info for this Regulation Number
Classification Product Code	ELC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/15/2014
Decision Date	08/20/2014
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