FDA 510(k) Application Details - K140990

Device Classification Name	Scaler, Ultrasonic   More FDA Info for this Device
510(K) Number	K140990
Device Name	Scaler, Ultrasonic
Applicant	E.M.S. ELECTRO MEDICAL SYSTEMS S.A. 62 FOREST ST., STE 300 MARLBOROUGH, MA 01752 US Other 510(k) Applications for this Company
Contact	TINA WU 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	04/17/2014
Decision Date	02/27/2015
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