FDA 510(k) Application Details - K163509

Device Classification Name	More FDA Info for this Device
510(K) Number	K163509
Device Name	XprESS ENT Dilation System
Applicant	Entellus Medical, Inc. 3600 Holly Lane North, Suite 40 Plymouth, MN 55447 US Other 510(k) Applications for this Company
Contact	Karen E. Peterson Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/15/2016
Decision Date	04/05/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review