FDA 510(k) Application Details - K030791

Device Classification Name	Masker, Tinnitus   More FDA Info for this Device
510(K) Number	K030791
Device Name	Masker, Tinnitus
Applicant	TINNITECH LTD 55 MARKET ST. LEVEL 2 SYDNEY NSW 2000 AU Other 510(k) Applications for this Company
Contact	LACHLAN JAMES 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	03/12/2003
Decision Date	04/17/2003
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