| 510(k) Number |
K827609 |
| Device Name |
MIDWEST AUTOMATIC BUCKY EQUIPPED WITH GRID AND SIZE-O-MATIC TRAY |
| Applicant |
| Midwest X-Ray Equipment Co. |
| 701 Illinois Ave. |
|
Aurora,
IL
60506
|
|
| Correspondent |
| Midwest X-Ray Equipment Co. |
| 701 Illinois Ave. |
|
Aurora,
IL
60506
|
|
| Date Received | 06/08/1982 |
| Decision Date | 07/09/1982 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|