FDA 510(k) Application Details - K013253

Device Classification Name	Masker, Tinnitus   More FDA Info for this Device
510(K) Number	K013253
Device Name	Masker, Tinnitus
Applicant	HEARING INNOVATIONS, INC. COLUMBIA SQUARE 555 THIRTEENTH STREET, NW WASHINGTON, DC 20004-1109 US Other 510(k) Applications for this Company
Contact	GERARD J PRUD'HOMME 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	09/28/2001
Decision Date	04/05/2002
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