FDA 510(k) Application Details - K093715

Device Classification Name	Masker, Tinnitus   More FDA Info for this Device
510(K) Number	K093715
Device Name	Masker, Tinnitus
Applicant	MAGNATONE HEARING AID CORP. DBA PERSONA MEDICAL 170 N. CYPRESS WAY CASSELBERRY, FL 32707 US Other 510(k) Applications for this Company
Contact	DON CAMPBELL 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	12/01/2009
Decision Date	12/22/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review