FDA 510(k) Application Details - DEN170009

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN170009
Device Name	Bonebridge
Applicant	MED-EL Elektromedizinische Geraete GmbH Fuerstenweg 77a Innsbruck 6020 AT Other 510(k) Applications for this Company
Contact	Elizabeth Gfoeller Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PFO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/13/2017
Decision Date	07/20/2018
Decision	DENG -
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review