FDA 510(k) Application Details - K151272

Device Classification Name	System, Applicator, Radionuclide, Remote-Controlled   More FDA Info for this Device
510(K) Number	K151272
Device Name	System, Applicator, Radionuclide, Remote-Controlled
Applicant	NUCLETRON B.V. WAARDGELDER 1 VEENENDAAL 3905 TH NL Other 510(k) Applications for this Company
Contact	Lizette Van de Streek 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	05/13/2015
Decision Date	06/23/2015
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