FDA 510(k) Application Details - K974339

Device Classification Name	Hearing Aid, Air Conduction   More FDA Info for this Device
510(K) Number	K974339
Device Name	Hearing Aid, Air Conduction
Applicant	UNITRON INDUSTRIES, INC. 3555 WALNUT ST. P.O. BOX 5010 PORT HURON, MI 48061-5010 US Other 510(k) Applications for this Company
Contact	SUSAN ARCHER 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	11/18/1997
Decision Date	12/12/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review