FDA 510(k) Application Details - K010283

Device Classification Name	Source, Brachytherapy, Radionuclide   More FDA Info for this Device
510(K) Number	K010283
Device Name	Source, Brachytherapy, Radionuclide
Applicant	THERAGENICS CORP. 5203 BRISTOL INDUSTRIAL WAY BUFORD, GA 30518 US Other 510(k) Applications for this Company
Contact	JANET E ZEMAN 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	01/30/2001
Decision Date	04/26/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review