| 510(k) Number |
K837413 |
| Device Name |
STRETCHER TOP TSI-107 |
| Applicant |
| Therapy Services, Inc. |
| 6243 Jefferson Pike |
|
Frederick,
MD
21701
|
|
| Correspondent |
| Therapy Services, Inc. |
| 6243 Jefferson Pike |
|
Frederick,
MD
21701
|
|
| Date Received | 04/19/1983 |
| Decision Date | 06/10/1983 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|