FDA 510(k) Application Details - K111254

Device Classification Name	Instrument, Ent Manual Surgical   More FDA Info for this Device
510(K) Number	K111254
Device Name	Instrument, Ent Manual Surgical
Applicant	ACCLARENT, INC. 1525-B O'BRIEN DR. MENLO PARK, CA 94025 US Other 510(k) Applications for this Company
Contact	KIM KY 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	05/04/2011
Decision Date	08/22/2011
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