I-SEED


Device Classification Name

source, brachytherapy, radionuclide

510(k) Number K103319
Device Name I-SEED
Applicant
THERAGENICS CORP.
5203 bristol industrial way
buford, 
GA 
30518

Applicant Contact besty cortelloni
Correspondent
THERAGENICS CORP.
5203 bristol industrial way
buford, 
GA 
30518

Correspodent Contact besty cortelloni
Regulation Number 892.5730
Classification Product Code
KXK  
Date Received 11/12/2010
Decision Date 01/03/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No