FDA 510(k) Application Details - K161123

Device Classification Name	Hearing Aid, Bone Conduction   More FDA Info for this Device
510(K) Number	K161123
Device Name	Hearing Aid, Bone Conduction
Applicant	Cochlear Americas 13059 E. Peakview Avenue Centennial, CO 80111 US Other 510(k) Applications for this Company
Contact	Laura Blair 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	04/21/2016
Decision Date	05/20/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review