Device Classification Name |
irradiator, blood to prevent graft versus host disease
|
510(k) Number |
K082921 |
Device Name |
RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400 |
Applicant |
RAD SOURCE TECHNOLOGIES, INC. |
6825 SHILOH ROAD EAST |
SUITE B2 |
alpharetta,
GA
30005
|
|
Applicant Contact |
randol e kirk |
Correspondent |
RAD SOURCE TECHNOLOGIES, INC. |
6825 SHILOH ROAD EAST |
SUITE B2 |
alpharetta,
GA
30005
|
|
Correspondent Contact |
randol e kirk |
Classification Product Code |
|
Date Received | 10/01/2008 |
Decision Date | 02/17/2009 |
Decision |
substantially equivalent
(SESE) |
510k Review Panel |
Radiology
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|