| 510(k) Number |
K827761 |
| Device Name |
MED-X MODEL 301 X-RAY FILTER |
| Applicant |
| Bfi- Medical Waste Systems |
| 1500 Hicks Rd. |
|
Rolling Meadows,
IL
60008
|
|
| Correspondent |
| Bfi- Medical Waste Systems |
| 1500 Hicks Rd. |
|
Rolling Meadows,
IL
60008
|
|
| Date Received | 07/12/1982 |
| Decision Date | 08/10/1982 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|