FDA 510(k) Application Details - K091154

Device Classification Name	System, Applicator, Radionuclide, Remote-Controlled   More FDA Info for this Device
510(K) Number	K091154
Device Name	System, Applicator, Radionuclide, Remote-Controlled
Applicant	NUCLETRON CORPORATION 8671 ROBERT FULTON DR. COLUMBIA, MD 21046 US Other 510(k) Applications for this Company
Contact	ELAINA COLBY 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	04/21/2009
Decision Date	05/18/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review