FDA 510(k) Application Details - K241261

Device Classification Name	Prosthesis, Partial Ossicular Replacement   More FDA Info for this Device
510(K) Number	K241261
Device Name	Prosthesis, Partial Ossicular Replacement
Applicant	MED-EL Elektromedizinische GerΣte GmbH Fⁿrstenweg 77a Innsbruck 6020 AT Other 510(k) Applications for this Company
Contact	InΘs Romßn Santiago Other 510(k) Applications for this Contact
Regulation Number	874.3450   More FDA Info for this Regulation Number
Classification Product Code	ETB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/26/2024
Decision Date	01/17/2025
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