| Device Classification Name |
Table, Radiologic
|
| 510(k) Number |
K951146 |
| Device Name |
IMAGING TABLE |
| Applicant |
| Septa Corp. |
| 123 Batchelder Rd. |
|
Mason,
NH
03048
|
|
| Applicant Contact |
CHRISTOPHER LEASK |
| Correspondent |
| Septa Corp. |
| 123 Batchelder Rd. |
|
Mason,
NH
03048
|
|
| Correspondent Contact |
CHRISTOPHER LEASK |
| Regulation Number | 892.1980 |
| Classification Product Code |
|
| Date Received | 03/13/1995 |
| Decision Date | 05/04/1995 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Radiology
|
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|