FDA 510(k) Application Details - K240919

Device Classification Name	System, Vocal Cord Medialization   More FDA Info for this Device
510(K) Number	K240919
Device Name	System, Vocal Cord Medialization
Applicant	Sofregen Medical 175 Crossing Blvd, Suite 510 Framingham, MA 01702 US Other 510(k) Applications for this Company
Contact	Vivian Ruan Other 510(k) Applications for this Contact
Regulation Number	874.3620   More FDA Info for this Regulation Number
Classification Product Code	MIX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/03/2024
Decision Date	05/03/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review