FDA 510(k) Application Details - K200504

Device Classification Name	More FDA Info for this Device
510(K) Number	K200504
Device Name	BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote
Applicant	MED-EL Elektromedizinische Geraete GmbH Fuerstenweg 77a Innsbruck 6020 AT Other 510(k) Applications for this Company
Contact	Carolin Ralser 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	03/02/2020
Decision Date	07/29/2020
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