FDA 510(k) Application Details - K082569

Device Classification Name	Nasopharyngoscope (Flexible Or Rigid)   More FDA Info for this Device
510(K) Number	K082569
Device Name	Nasopharyngoscope (Flexible Or Rigid)
Applicant	Entellus Medical, Inc. 18555 37TH AVENUE NORTH PLYMOUTH, MN 55446 US Other 510(k) Applications for this Company
Contact	Sew-Wah Tay Other 510(k) Applications for this Contact
Regulation Number	874.4760   More FDA Info for this Regulation Number
Classification Product Code	EOB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/05/2008
Decision Date	09/18/2008
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	Y
Expedited Review