FDA 510(k) Application Details - K151912

Device Classification Name	Handpiece, Air-Powered, Dental   More FDA Info for this Device
510(K) Number	K151912
Device Name	Handpiece, Air-Powered, Dental
Applicant	E.M.S. ELECTRO MEDICAL SYSTEMS S.A. Rte de Champ-Colin 2 Nyon CH-1260 CH Other 510(k) Applications for this Company
Contact	Suzanne Fassio-Hardy Other 510(k) Applications for this Contact
Regulation Number	872.4200   More FDA Info for this Regulation Number
Classification Product Code	EFB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/13/2015
Decision Date	02/03/2016
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