FDA 510(k) Application Details - K192771

Device Classification Name	Marker, Radiographic, Implantable   More FDA Info for this Device
510(K) Number	K192771
Device Name	Marker, Radiographic, Implantable
Applicant	C4 Imaging LLC 196 West Ashland Street Doylestown, PA 18901 US Other 510(k) Applications for this Company
Contact	Andrew Bright 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	09/30/2019
Decision Date	10/21/2020
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