| 510(k) Number |
K900416 |
| Device Name |
HAND CONTROLS, MODEL 3700 AND 3500 SERIES |
| Applicant |
| Mobility Products & Design |
| 14800 28th Ave. N. |
|
Plymouth,
MN
55447
|
|
| Applicant Contact |
KENNETH B HERLAND |
| Correspondent |
| Mobility Products & Design |
| 14800 28th Ave. N. |
|
Plymouth,
MN
55447
|
|
| Correspondent Contact |
KENNETH B HERLAND |
| Classification Product Code |
|
| Date Received | 01/30/1990 |
| Decision Date | 05/30/1990 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Physical Medicine
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|