FDA 510(k) Application Details - K171761

Device Classification Name	More FDA Info for this Device
510(K) Number	K171761
Device Name	ACCLARENT AERA Eustachian Tube Balloon Dilation System
Applicant	Acclarent, Inc. 33 Technology Drive Irvine, CA 92618 US Other 510(k) Applications for this Company
Contact	James Patrick Garvey II 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	06/14/2017
Decision Date	01/16/2018
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