FDA 510(k) Application Details - K091378

Device Classification Name	System, Applicator, Radionuclide, Remote-Controlled   More FDA Info for this Device
510(K) Number	K091378
Device Name	System, Applicator, Radionuclide, Remote-Controlled
Applicant	HOLOGIC, INC. 250 CAMPUS DRIVE MARLBOROUGH, MA 01752 US Other 510(k) Applications for this Company
Contact	JENNIFER SULLIVAN 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	05/11/2009
Decision Date	07/02/2009
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