FDA 510(k) Application Details - K082108

Device Classification Name	Hearing Aid, Bone Conduction   More FDA Info for this Device
510(K) Number	K082108
Device Name	Hearing Aid, Bone Conduction
Applicant	OTICON MEDICAL AB EKONOMIV 2 GOTHENBURG, ASKIM SE-436 33 SE Other 510(k) Applications for this Company
Contact	KAROLIN ISBERG Other 510(k) Applications for this Contact
Regulation Number	874.3300   More FDA Info for this Regulation Number
Classification Product Code	LXB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/25/2008
Decision Date	11/14/2008
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