FDA 510(k) Application Details - K190689

Device Classification Name	Marker, Radiographic, Implantable   More FDA Info for this Device
510(K) Number	K190689
Device Name	Marker, Radiographic, Implantable
Applicant	View Point Medical, Inc. 5621 Palmer Way, Suite F Carlsbad, CA 92010 US Other 510(k) Applications for this Company
Contact	Thomas Kane 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	03/18/2019
Decision Date	08/14/2019
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