FDA 510(k) Application Details - K161406

Device Classification Name	More FDA Info for this Device
510(K) Number	K161406
Device Name	Navident
Applicant	ClaroNav Inc. 1140 Sheppard Avenue West, Unit 10 Toronto M3K 2A2 CA Other 510(k) Applications for this Company
Contact	Doron Dekel Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PLV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/20/2016
Decision Date	09/08/2016
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