| 510(k) Number |
K827470 |
| Device Name |
STATIONARY SPECIAL PURPOSE PODIATRY X-RAY UNIT |
| Applicant |
| Franklin X-Ray Corp. |
| 22 N 49 Pepper Rd. |
|
Barrington,
IL
60010
|
|
| Correspondent |
| Franklin X-Ray Corp. |
| 22 N 49 Pepper Rd. |
|
Barrington,
IL
60010
|
|
| Date Received | 05/13/1982 |
| Decision Date | 06/11/1982 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|