| 510(k) Number |
K837105 |
| Device Name |
ELDER PSORALITE, SERIES 43000 |
| Applicant |
| Elder Pharmaceuticals, Inc. |
| 705 E. Mulberry St. |
|
Bryan,
OH
43506
|
|
| Correspondent |
| Elder Pharmaceuticals, Inc. |
| 705 E. Mulberry St. |
|
Bryan,
OH
43506
|
|
| Date Received | 01/10/1983 |
| Decision Date | 03/07/1983 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|