| 510(k) Number |
K842625 |
| Device Name |
CUSTOM NEURO TRAY |
| Applicant |
| Deroyal Industries, Inc. |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Correspondent |
| Deroyal Industries, Inc. |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Date Received | 07/06/1984 |
| Decision Date | 09/20/1984 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Neurology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|