FDA 510(k) Application Details - K140542

Device Classification Name	Irrigator, Powered Nasal   More FDA Info for this Device
510(K) Number	K140542
Device Name	Irrigator, Powered Nasal
Applicant	RHINOSYSTEMS, INC. 5399 Lancaster Dr # 6 Brooklyn Heights, OH 44131 US Other 510(k) Applications for this Company
Contact	MARTIN R HOKE Other 510(k) Applications for this Contact
Regulation Number	874.5550   More FDA Info for this Regulation Number
Classification Product Code	KMA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/04/2014
Decision Date	06/27/2014
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