FDA 510(k) Application Details - K972039

Device Classification Name	Hearing Aid, Air Conduction   More FDA Info for this Device
510(K) Number	K972039
Device Name	Hearing Aid, Air Conduction
Applicant	NU-SOUND 2501 WEST MEMORIAL QUAIL SPRINGS MALL OKLAHOMA CITY, OK 73134 US Other 510(k) Applications for this Company
Contact	WAVA BRIANS 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	06/02/1997
Decision Date	08/25/1997
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