FDA 510(k) Application Details - K103319

Device Classification Name	Source, Brachytherapy, Radionuclide   More FDA Info for this Device
510(K) Number	K103319
Device Name	Source, Brachytherapy, Radionuclide
Applicant	THERAGENICS CORP. 5203 BRISTOL INDUSTRIAL WAY BUFORD, GA 30518 US Other 510(k) Applications for this Company
Contact	BESTY CORTELLONI Other 510(k) Applications for this Contact
Regulation Number	892.5730   More FDA Info for this Regulation Number
Classification Product Code	KXK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/12/2010
Decision Date	01/03/2011
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