FDA 510(k) Application Details - K091598

Device Classification Name	System, Applicator, Radionuclide, Remote-Controlled   More FDA Info for this Device
510(K) Number	K091598
Device Name	System, Applicator, Radionuclide, Remote-Controlled
Applicant	NUCLETRON CORP. 8671 ROBERT FULTON DRIVE 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	06/03/2009
Decision Date	06/29/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review