FDA 510(k) Application Details - K070599

Device Classification Name	Masker, Tinnitus   More FDA Info for this Device
510(K) Number	K070599
Device Name	Masker, Tinnitus
Applicant	TINNITUS OTOSOUND PRODUCTS, LLC 880 FIRST ST., SUITE 403 LOS ANGELES, CA 90012 US Other 510(k) Applications for this Company
Contact	GERALDINE CREAN 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	03/02/2007
Decision Date	07/13/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review