FDA 510(k) Application Details - K971032

Device Classification Name	Hearing Aid, Air Conduction   More FDA Info for this Device
510(K) Number	K971032
Device Name	Hearing Aid, Air Conduction
Applicant	GN DANAVOX, INC. 5600 ROWLAND RD., SUITE 250 MINNETONKA, MN 55343 US Other 510(k) Applications for this Company
Contact	WAYNE MORRIS 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	03/21/1997
Decision Date	06/17/1997
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