| Device Classification Name |
Stimulator, Nerve, Transcutaneous, For Pain Relief
|
| 510(k) Number |
K883236 |
| Device Name |
CEFAR DUAL |
| Applicant |
| Cefar Medical Products, Inc. |
| C/O Martin S. Knopf Assoc. Inc |
| 28 Marigold Ln. |
|
Marlboro,
NJ
07746
|
|
| Applicant Contact |
MARTIN S KNOPF |
| Correspondent |
| Cefar Medical Products, Inc. |
| C/O Martin S. Knopf Assoc. Inc |
| 28 Marigold Ln. |
|
Marlboro,
NJ
07746
|
|
| Correspondent Contact |
MARTIN S KNOPF |
| Regulation Number | 882.5890 |
| Classification Product Code |
|
| Date Received | 08/01/1988 |
| Decision Date | 11/16/1988 |
| 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
|
|
|