| 510(k) Number |
K837245 |
| Device Name |
TRANSPARENT X-RAY COMPENSATION FILTER |
| Applicant |
| Victoreen, Inc. |
| 100 Voice Rd. |
|
Carle Place,
NY
11514
|
|
| Correspondent |
| Victoreen, Inc. |
| 100 Voice Rd. |
|
Carle Place,
NY
11514
|
|
| Date Received | 03/08/1983 |
| Decision Date | 04/28/1983 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|