FDA 510(k) Application Details - K250869

Device Classification Name	Mesh, Surgical, Polymeric   More FDA Info for this Device
510(K) Number	K250869
Device Name	Mesh, Surgical, Polymeric
Applicant	Sofradim Production 116, Avenue du Formans TrΘvoux 01600 FR Other 510(k) Applications for this Company
Contact	Jhony Mallet Other 510(k) Applications for this Contact
Regulation Number	878.3300   More FDA Info for this Regulation Number
Classification Product Code	FTL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/24/2025
Decision Date	04/23/2025
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