FDA 510(k) Application Details - K182116

Device Classification Name	Hearing Aid, Bone Conduction, Implanted   More FDA Info for this Device
510(K) Number	K182116
Device Name	Hearing Aid, Bone Conduction, Implanted
Applicant	Cochlear Americas 13059 E. Peakview Ave. Centennial, CO 80111 US Other 510(k) Applications for this Company
Contact	Beth Murray 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	08/06/2018
Decision Date	12/19/2018
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