FDA 510(k) Application Details - K240763

Device Classification Name	Prosthesis, Laryngeal (Taub)   More FDA Info for this Device
510(K) Number	K240763
Device Name	Prosthesis, Laryngeal (Taub)
Applicant	Freudenberg Medical LLC 1110 Mark Ave Carpinteria, CA 93013 US Other 510(k) Applications for this Company
Contact	Oliver Krause-Huckelberry Other 510(k) Applications for this Contact
Regulation Number	874.3730   More FDA Info for this Regulation Number
Classification Product Code	EWL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/20/2024
Decision Date	12/18/2024
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