FDA 510(k) Application Details - K161698

Device Classification Name	Instrument, Ent Manual Surgical   More FDA Info for this Device
510(K) Number	K161698
Device Name	Instrument, Ent Manual Surgical
Applicant	ACCLARENT, INC. 33 TECHNOLOGY DRIVE IRVINE, CA 92618 US Other 510(k) Applications for this Company
Contact	JAMES PATRICK GARVEY Other 510(k) Applications for this Contact
Regulation Number	874.4420   More FDA Info for this Regulation Number
Classification Product Code	LRC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/20/2016
Decision Date	10/24/2016
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