FDA 510(k) Application Details - K233991

Device Classification Name	Mesh, Surgical   More FDA Info for this Device
510(K) Number	K233991
Device Name	Mesh, Surgical
Applicant	Elutia Inc. 1100 Old Ellis Road Suite 1200 Roswell, GA 30076 US Other 510(k) Applications for this Company
Contact	Erica Elchin Other 510(k) Applications for this Contact
Regulation Number	878.3300   More FDA Info for this Regulation Number
Classification Product Code	FTM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/18/2023
Decision Date	06/14/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review