FDA 510(k) Application Details - K082530

Device Classification Name	System, Applicator, Radionuclide, Remote-Controlled   More FDA Info for this Device
510(K) Number	K082530
Device Name	System, Applicator, Radionuclide, Remote-Controlled
Applicant	ISODOSE CONTROL B.V. MAXWELLSTRAAT 16 EDE 6716 BX 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	09/02/2008
Decision Date	10/30/2008
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