FDA 510(k) Application Details - K231579

Device Classification Name	Marker, Radiographic, Implantable   More FDA Info for this Device
510(K) Number	K231579
Device Name	Marker, Radiographic, Implantable
Applicant	MOLLI Surgical, Inc. 50 Wellington Street East Suite 400 Toronto M5E 1C8 CA Other 510(k) Applications for this Company
Contact	Joseph De Croos Other 510(k) Applications for this Contact
Regulation Number	878.4300   More FDA Info for this Regulation Number
Classification Product Code	NEU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/31/2023
Decision Date	10/26/2023
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