FDA 510(k) Application Details - K243595

Device Classification Name	Mesh, Surgical   More FDA Info for this Device
510(K) Number	K243595
Device Name	Mesh, Surgical
Applicant	TELA Bio, Inc. 1 Great Valley Parkway Suite 24 Malvern, PA 19355 US Other 510(k) Applications for this Company
Contact	John Urtz 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	11/20/2024
Decision Date	12/19/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review