| Device Classification Name |
Component, External, Limb, Ankle/Foot
|
| 510(k) Number |
K791331 |
| Device Name |
THE TUCKER-SACH FOOT AND TUCKER-SYME FT |
| Applicant |
| Kiswood Manufacturing, Inc. |
| 4221 Richmond Rd., NW |
|
Walker,
MI
49534
|
|
| Correspondent |
| Kiswood Manufacturing, Inc. |
| 4221 Richmond Rd., NW |
|
Walker,
MI
49534
|
|
| Regulation Number | 890.3420 |
| Classification Product Code |
|
| Date Received | 07/18/1979 |
| Decision Date | 08/03/1979 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Physical Medicine
|
| 510k Review Panel |
Physical Medicine
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|