| 510(k) Number |
K864631 |
| Device Name |
MOORE'S STRAIGHT & THOMPSON'S CURVED STEM PROSTHE. |
| Applicant |
| Downs Surgical , Ltd. |
| Church Path |
|
Mitcham Surrey,
GB
|
|
| Applicant Contact |
GEOFFREY W DOWN |
| Correspondent |
| Downs Surgical , Ltd. |
| Church Path |
|
Mitcham Surrey,
GB
|
|
| Correspondent Contact |
GEOFFREY W DOWN |
| Date Received | 11/25/1986 |
| Decision Date | 12/18/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Orthopedic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|