FDA 510(k) Application Details - K180948

Device Classification Name	More FDA Info for this Device
510(K) Number	K180948
Device Name	TruDi NAV Suction Instruments
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	PGW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/11/2018
Decision Date	07/20/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review