FDA 510(k) Application Details - DEN150056

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN150056
Device Name	Acclarent Aera Eustachian Tube Balloon Dilation System
Applicant	ACCLARENT, INC. 1525-B O'BRIEN DR. MENLO PARK, CA 94025 US Other 510(k) Applications for this Company
Contact	JAMES PATRICK GARVEY 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	12/07/2015
Decision Date	09/16/2016
Decision	DENG -
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review