FDA 510(k) Application Details - K161021

Device Classification Name	Marker, Radiographic, Implantable   More FDA Info for this Device
510(K) Number	K161021
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	SHAWNA ROSE 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	04/12/2016
Decision Date	05/05/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review