FDA 510(k) Application Details - K132996

Device Classification Name	Source, Brachytherapy, Radionuclide   More FDA Info for this Device
510(K) Number	K132996
Device Name	Source, Brachytherapy, Radionuclide
Applicant	ISORAY, INC 350 Hills Street Suite 106 RICHLAND, WA 99354 US Other 510(k) Applications for this Company
Contact	FREDRIC SWINDLER 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	09/24/2013
Decision Date	12/17/2013
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