FDA 510(k) Application Details - K180631

Device Classification Name	System, Vocal Cord Medialization   More FDA Info for this Device
510(K) Number	K180631
Device Name	System, Vocal Cord Medialization
Applicant	Sofregen Medical, Inc. 200 Boston Avenue, Suite 1100 Medford, MA 02155 US Other 510(k) Applications for this Company
Contact	Anh Hoang 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	03/09/2018
Decision Date	11/08/2018
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