GLIASITE RTS


Device Classification Name

source, brachytherapy, radionuclide

510(k) Number K111931
Device Name GLIASITE RTS
Applicant
ISORAY MEDICAL, INC.
350 hills st., suite 106
richland, 
WA 
99354 -5411

Applicant Contact fredric g swindler
Correspondent
ISORAY MEDICAL, INC.
350 hills st., suite 106
richland, 
WA 
99354 -5411

Correspodent Contact fredric g swindler
Regulation Number 892.5730
Classification Product Code
KXK  
Date Received 07/08/2011
Decision Date 08/05/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No