FDA 510(k) Application Details - K000081

Device Classification Name	System, Applicator, Radionuclide, Remote-Controlled   More FDA Info for this Device
510(K) Number	K000081
Device Name	System, Applicator, Radionuclide, Remote-Controlled
Applicant	ISOTOPES AND METALS LTD. 29, CH DE GRANGE CANAL GENEVA CH-1208 CH Other 510(k) Applications for this Company
Contact	GIOVANNI LEO 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	01/11/2000
Decision Date	12/19/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review