FDA 510(k) Application Details - K974152

Device Classification Name	Hearing Aid, Air Conduction   More FDA Info for this Device
510(K) Number	K974152
Device Name	Hearing Aid, Air Conduction
Applicant	BERNAFON-MAICO, INC. 9675 WEST 76TH ST. EDEN PRAIRIE, MN 55344 US Other 510(k) Applications for this Company
Contact	RAY ENROTH 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	11/04/1997
Decision Date	12/15/1997
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