FDA 510(k) Application Details - K112420

Device Classification Name	System, Applicator, Radionuclide, Remote-Controlled   More FDA Info for this Device
510(K) Number	K112420
Device Name	System, Applicator, Radionuclide, Remote-Controlled
Applicant	NUCLETRON 7021 COLUMBIA GATEWAY DRIVE SUITE 200 COLUMBIA, MD 21046 US Other 510(k) Applications for this Company
Contact	MICHAEL PAUL 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	08/23/2011
Decision Date	11/18/2011
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