FDA 510(k) Application Details - K143445

Device Classification Name	Handpiece, Direct Drive, Ac-Powered   More FDA Info for this Device
510(K) Number	K143445
Device Name	Handpiece, Direct Drive, Ac-Powered
Applicant	Tellos Medical AB Nedergardsgatan 5 Goteborg 41654 SE Other 510(k) Applications for this Company
Contact	Anders Petersson Other 510(k) Applications for this Contact
Regulation Number	872.4200   More FDA Info for this Regulation Number
Classification Product Code	EKX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/02/2014
Decision Date	01/07/2016
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