FDA 510(k) Application Details - K973043

Device Classification Name	Hearing Aid, Air Conduction   More FDA Info for this Device
510(K) Number	K973043
Device Name	Hearing Aid, Air Conduction
Applicant	BETTER HEARING, INC. 112 ELDEN ST. HERNDON, VA 20170-4809 US Other 510(k) Applications for this Company
Contact	LOUIS T GNECCO 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	08/15/1997
Decision Date	10/27/1997
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