FDA 510(k) Application Details - K070574

Device Classification Name	System, Applicator, Radionuclide, Remote-Controlled   More FDA Info for this Device
510(K) Number	K070574
Device Name	System, Applicator, Radionuclide, Remote-Controlled
Applicant	ISODOSE CONTROL B.V. LANDJUWEEL 11 VEENENDAAL 3905 PE NL Other 510(k) Applications for this Company
Contact	HUB VAN DE BERGH 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	02/28/2007
Decision Date	04/13/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review