FDA 510(k) Application Details - K191457

Device Classification Name	More FDA Info for this Device
510(K) Number	K191457
Device Name	BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)
Applicant	MED-EL Elektromedizinische Geraete GmbH Fuestenweg 77a Innsbruck 6020 AT Other 510(k) Applications for this Company
Contact	Ines Roman Santiago 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	05/31/2019
Decision Date	09/18/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review