FDA 510(k) Application Details - K040330

Device Classification Name	Masker, Tinnitus   More FDA Info for this Device
510(K) Number	K040330
Device Name	Masker, Tinnitus
Applicant	SPECTRAL VISUALIZATION & DEVELOPMENT, INC. 921 COLLEGE HILL RD. FREDERICTON, NEW BRUNSWICK E3B 6Z9 CA Other 510(k) Applications for this Company
Contact	DENNIS WOO 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	02/11/2004
Decision Date	04/12/2004
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