FDA 510(k) Application Details - K161688

Device Classification Name	System, Applicator, Radionuclide, Remote-Controlled   More FDA Info for this Device
510(K) Number	K161688
Device Name	System, Applicator, Radionuclide, Remote-Controlled
Applicant	NUCLETRON BV WAARDGELDER 1 VEENENDAAL 3905 TH NL Other 510(k) Applications for this Company
Contact	RUDOLF VOS 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	06/20/2016
Decision Date	01/27/2017
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