FDA 510(k) Application Details - K160410

Device Classification Name	Handpiece, Air-Powered, Dental   More FDA Info for this Device
510(K) Number	K160410
Device Name	Handpiece, Air-Powered, Dental
Applicant	Dental Savings Club 31 Serge Garant Montreal h3E 0A6 CA Other 510(k) Applications for this Company
Contact	Chadi Saade 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	02/16/2016
Decision Date	09/29/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review