| Device Classification Name |
Component, Cast
|
| 510(k) Number |
K810110 |
| Device Name |
COBBLER'S CHIP SPLINTS |
| Applicant |
| Secol Co. |
| 4221 Richmond Rd., NW |
|
Walker,
MI
49534
|
|
| Correspondent |
| Secol Co. |
| 4221 Richmond Rd., NW |
|
Walker,
MI
49534
|
|
| Regulation Number | 888.5940 |
| Classification Product Code |
|
| Date Received | 01/16/1981 |
| Decision Date | 01/26/1981 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Orthopedic
|
| 510k Review Panel |
Orthopedic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|