FDA 510(k) Application Details - K092534

Device Classification Name	System, Applicator, Radionuclide, Remote-Controlled   More FDA Info for this Device
510(K) Number	K092534
Device Name	System, Applicator, Radionuclide, Remote-Controlled
Applicant	RADIADYNE 1795 S. CAPITAL OF TEXAS HWY SUITE 500 AUSTIN, TX 78746 US Other 510(k) Applications for this Company
Contact	STUART R GOLDMAN 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	08/19/2009
Decision Date	12/07/2009
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