FDA 510(k) Application Details - K203097

Device Classification Name	Marker, Radiographic, Implantable   More FDA Info for this Device
510(K) Number	K203097
Device Name	Marker, Radiographic, Implantable
Applicant	Devicor Medical Products, Inc 300 E-Business Way, Fifth Floor Cincinnati, OH 45241 US Other 510(k) Applications for this Company
Contact	Rhonda M. Kops 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	10/14/2020
Decision Date	12/16/2020
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