FDA 510(k) Application Details - K201983

Device Classification Name	More FDA Info for this Device
510(K) Number	K201983
Device Name	BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)
Applicant	Med-El Elektromedizinische Geraete GmbH Fuerstenweg 77a Innsbruck 6020 AT Other 510(k) Applications for this Company
Contact	Stephanie Haselwanter 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	07/17/2020
Decision Date	10/09/2020
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