FDA 510(k) Application Details - K080565

Device Classification Name	System, Applicator, Radionuclide, Remote-Controlled   More FDA Info for this Device
510(K) Number	K080565
Device Name	System, Applicator, Radionuclide, Remote-Controlled
Applicant	CIANNA MEDICAL, INC. 6 JOURNEY SUITE 125 ALISO VIEJO, CA 92656 US Other 510(k) Applications for this Company
Contact	GARY MOCNIK 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	02/29/2008
Decision Date	04/04/2008
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review