FDA 510(k) Application Details - K180640

Device Classification Name	Marker, Radiographic, Implantable   More FDA Info for this Device
510(K) Number	K180640
Device Name	Marker, Radiographic, Implantable
Applicant	Elucent Medical, Inc. 7480 Flying Cloud Drive, Suite 101 Eden Prairie, MN 55344 US Other 510(k) Applications for this Company
Contact	Debra Kridner 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	03/12/2018
Decision Date	06/04/2018
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