FDA 510(k) Application Details - K183090

Device Classification Name	More FDA Info for this Device
510(K) Number	K183090
Device Name	Relieva Tract Balloon Dilation System
Applicant	Acclarent, Inc. 33 Technology Drive Irvine, CA 92618 US Other 510(k) Applications for this Company
Contact	Leena Sorathia Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QGK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/06/2018
Decision Date	04/19/2019
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