| Device Classification Name |
Stimulator, Neuromuscular, External Functional
|
| 510(k) Number |
K873608 |
| Device Name |
TENS LEAD |
| Applicant |
| Desco Industries, Inc. |
| 761 Penarth Ave. |
|
Walnut,
CA
91789
|
|
| Applicant Contact |
JEFF B REICH |
| Correspondent |
| Desco Industries, Inc. |
| 761 Penarth Ave. |
|
Walnut,
CA
91789
|
|
| Correspondent Contact |
JEFF B REICH |
| Regulation Number | 882.5810 |
| Classification Product Code |
|
| Date Received | 09/08/1987 |
| Decision Date | 09/30/1987 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Neurology
|
| 510k Review Panel |
Neurology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|