FDA 510(k) Application Details - K120590

Device Classification Name	More FDA Info for this Device
510(K) Number	K120590
Device Name	DILATOR TUBE SET
Applicant	KOROS USA, INC. 610 FLINN AVE. MOORPARK, CA 93021 US Other 510(k) Applications for this Company
Contact	GABRIEL KOROS Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PDQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/28/2012
Decision Date	05/07/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review