FDA 510(k) Application Details - K111293

Device Classification Name	Masker, Tinnitus   More FDA Info for this Device
510(K) Number	K111293
Device Name	Masker, Tinnitus
Applicant	SOUNDCURE INC 560 SOUTH WINCHESTER BLVD SUITE 500 SAN JOSE, CA 95128 US Other 510(k) Applications for this Company
Contact	NANCY LINCE Other 510(k) Applications for this Contact
Regulation Number	874.3400   More FDA Info for this Regulation Number
Classification Product Code	KLW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/06/2011
Decision Date	08/24/2011
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