| 510(k) Number |
K850172 |
| Device Name |
ELEKIBAN MAGNETO-THERAPEUTIC DEVICE |
| Applicant |
| Mns, Ltd. |
| 1575 Eye St. NW |
|
Washington,
DC
20005
|
|
| Applicant Contact |
STANLEY W LANDFAIR |
| Correspondent |
| Mns, Ltd. |
| 1575 Eye St. NW |
|
Washington,
DC
20005
|
|
| Correspondent Contact |
STANLEY W LANDFAIR |
| Date Received | 01/16/1985 |
| Decision Date | 04/16/1985 |
| 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
|
|
|