| Device Classification Name |
Apparatus, Traction, Non-Powered
|
| 510(k) Number |
K822993 |
| Device Name |
SENATEK |
| Applicant |
| AMERICAN HEALTH TECH., INC. |
| 803 N. Front St. Suite 3 |
|
McHenry,
IL
60050
|
|
| Correspondent |
| AMERICAN HEALTH TECH., INC. |
| 803 N. Front St. Suite 3 |
|
McHenry,
IL
60050
|
|
| Regulation Number | 888.5850 |
| Classification Product Code |
|
| Date Received | 10/12/1982 |
| Decision Date | 10/26/1982 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Orthopedic
|
| 510k Review Panel |
Neurology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|