POIINT OF CARE STRANDING SYSTEM, MODE 1004-00


Device Classification Name

source, brachytherapy, radionuclide

510(k) Number K072296
Device Name POIINT OF CARE STRANDING SYSTEM, MODE 1004-00
Applicant
THERAGENICS CORP.
5203 bristol industrial way
buford, 
GA 
30518

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

Correspodent Contact betsy cortelloni
Regulation Number 892.5730
Classification Product Code
KXK  
Date Received 08/17/2007
Decision Date 09/26/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls