FDA 510(k) Application Details - K961059

Device Classification Name	Hearing Aid, Air Conduction   More FDA Info for this Device
510(K) Number	K961059
Device Name	Hearing Aid, Air Conduction
Applicant	OTICON, INC. 29 SCHOOLHOUSE RD. SOMERSET, NJ 08873 US Other 510(k) Applications for this Company
Contact	PREBEN BRUNVED 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	03/18/1996
Decision Date	05/07/1996
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