FDA 510(k) Application Details - K142719

Device Classification Name	System, Applicator, Radionuclide, Remote-Controlled   More FDA Info for this Device
510(K) Number	K142719
Device Name	System, Applicator, Radionuclide, Remote-Controlled
Applicant	GC MEDTECH, LLC 490 West 84th Street Hialeah, FL 33014 US Other 510(k) Applications for this Company
Contact	Robert Ramirez Other 510(k) Applications for this Contact
Regulation Number	892.5700   More FDA Info for this Regulation Number
Classification Product Code	JAQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/23/2014
Decision Date	05/20/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review