| 510(k) Number |
K864117 |
| Device Name |
SUPPORT ARM |
| Applicant |
| Leonard Medical, Inc. |
| 1464 Holcomb Rd. |
|
Huntingdon Valley,
PA
19006
|
|
| Applicant Contact |
LEONARD J BONNELL |
| Correspondent |
| Leonard Medical, Inc. |
| 1464 Holcomb Rd. |
|
Huntingdon Valley,
PA
19006
|
|
| Correspondent Contact |
LEONARD J BONNELL |
| Date Received | 10/21/1986 |
| Decision Date | 11/03/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Neurology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|