FDA 510(k) Application Details - K233661

Device Classification Name	More FDA Info for this Device
510(K) Number	K233661
Device Name	TransorbÖ Self-Gripping Resorbable Mesh
Applicant	Sofradim Production 116, Avenue du Formans TrΘvoux 01600 FR Other 510(k) Applications for this Company
Contact	Mickaδl Nicolas Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/15/2023
Decision Date	02/13/2024
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