FDA 510(k) Application Details - K981704

Device Classification Name	Masker, Tinnitus   More FDA Info for this Device
510(K) Number	K981704
Device Name	Masker, Tinnitus
Applicant	ADM TRONICS UNLTD, INC. P.O. BOX 2002 MORRISTOWN, TN 37816 US Other 510(k) Applications for this Company
Contact	JAMES E LENICK 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	05/14/1998
Decision Date	08/05/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review