Device Classification Name |
irradiator, blood to prevent graft versus host disease
|
510(k) Number |
K161324 |
Device Name |
Raycell Mk2 |
Applicant |
Best Theratronics Limited |
413 March Road |
ottawa,
CA
k2k 0e4
|
|
Applicant Contact |
mike de van der schueren |
Correspondent |
Best Theratronics Limited |
413 March Road |
ottawa,
CA
k2k 0e4
|
|
Correspondent Contact |
mike de van der schueren |
Classification Product Code |
|
Date Received | 05/11/2016 |
Decision Date | 08/12/2016 |
Decision |
substantially equivalent
(SESE) |
510k Review Panel |
Radiology
|
summary |
summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|