FDA 510(k) Application Details - K121228

Device Classification Name	Hearing Aid, Bone Conduction, Implanted   More FDA Info for this Device
510(K) Number	K121228
Device Name	Hearing Aid, Bone Conduction, Implanted
Applicant	OTICON MEDICAL AB EKONOMIVAGEN 2 ASKIM SE-436 33 SE Other 510(k) Applications for this Company
Contact	KAROLIN ISBERG JERNBY Other 510(k) Applications for this Contact
Regulation Number	874.3300   More FDA Info for this Regulation Number
Classification Product Code	MAH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/23/2012
Decision Date	09/07/2012
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