FDA 510(k) Application Details - K021202

Device Classification Name	Masker, Tinnitus   More FDA Info for this Device
510(K) Number	K021202
Device Name	Masker, Tinnitus
Applicant	SOUND TECHNIQUE SYSTEM, LLC 555 THIRTTEENTH ST. N.W. WASHINGTON, DC 20004 US Other 510(k) Applications for this Company
Contact	HOWARD M HOLSTEIN 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	04/16/2002
Decision Date	07/13/2002
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