FDA 510(k) Application Details - K960494

Device Classification Name	Hearing Aid, Air Conduction   More FDA Info for this Device
510(K) Number	K960494
Device Name	Hearing Aid, Air Conduction
Applicant	STARKEY LABORATORIES, INC. 6600 WASHINGTON AVE. SOUTH EDEN PRAIRIE, MN 55344 US Other 510(k) Applications for this Company
Contact	RICK STROMBERG Other 510(k) Applications for this Contact
Regulation Number	874.3300   More FDA Info for this Regulation Number
Classification Product Code	ESD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/30/1996
Decision Date	03/01/1996
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