FDA 510(k) Application Details - K231468

Device Classification Name	Marker, Radiographic, Implantable   More FDA Info for this Device
510(K) Number	K231468
Device Name	Marker, Radiographic, Implantable
Applicant	Merit Medical System, Inc. 1600 West Merit Parkway South Jordan, UT 84095 US Other 510(k) Applications for this Company
Contact	Saboo Sandeep 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	05/22/2023
Decision Date	02/12/2024
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