FDA 510(k) Application Details - K112506

Device Classification Name	Instrument, Ent Manual Surgical   More FDA Info for this Device
510(K) Number	K112506
Device Name	Instrument, Ent Manual Surgical
Applicant	Entellus Medical, Inc. 6705 WEDGWOOD COURT NORTH MAPLE GROVE, MN 55311 US Other 510(k) Applications for this Company
Contact	KAREN E PETERSON 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	08/30/2011
Decision Date	12/21/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review