FDA 510(k) Application Details - K081606

Device Classification Name	Hearing Aid, Bone Conduction   More FDA Info for this Device
510(K) Number	K081606
Device Name	Hearing Aid, Bone Conduction
Applicant	COCHLEAR AMERICAS 400 INVERNESS PARKWAY, SUITE 400 ENGLEWOOD, CO 80112 US Other 510(k) Applications for this Company
Contact	SEAN BUNDY 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	06/06/2008
Decision Date	08/28/2008
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