| Device Classification Name |
Stimulator, Spinal-Cord, Implanted (Pain Relief)
|
| 510(k) Number |
K941342 |
| Device Name |
PAIN DOC |
| Applicant |
| Regulatory & Marketing Services, Inc. |
| P.O. Box 2010 |
|
Palm Harbor,
FL
34682
|
|
| Applicant Contact |
PATRICK J LAMB |
| Correspondent |
| Regulatory & Marketing Services, Inc. |
| P.O. Box 2010 |
|
Palm Harbor,
FL
34682
|
|
| Correspondent Contact |
PATRICK J LAMB |
| Regulation Number | 882.5880 |
| Classification Product Code |
|
| Date Received | 02/22/1994 |
| Decision Date | 10/13/1995 |
| 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
|
|
|