Device Classification Name |
system, applicator, radionuclide, remote-controlled
|
510(k) Number |
K070574 |
Device Name |
FLEXITRON |
Applicant |
ISODOSE CONTROL B.V. |
LANDJUWEEL 11 |
VEENENDAAL,
NL
3905 PE
|
|
Applicant Contact |
HUB VAN DE BERGH |
Correspondent |
ISODOSE CONTROL B.V. |
LANDJUWEEL 11 |
VEENENDAAL,
NL
3905 PE
|
|
Correspondent Contact |
HUB VAN DE BERGH |
Regulation Number | 892.5700
|
Classification Product Code |
|
Date Received | 02/28/2007 |
Decision Date | 04/13/2007 |
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
|
|
|