| Device Classification Name |
Stimulator, Nerve, Transcutaneous, For Pain Relief
|
| 510(k) Number |
K852836 |
| Device Name |
ADVANCED MEDICAL PRODUCTS MINI-M (TENS) |
| Applicant |
| Advanced Medical Products, Inc. |
| 384 Pratt St. |
|
Meriden,
CT
06450
|
|
| Applicant Contact |
CHARLES A GARCIA |
| Correspondent |
| Advanced Medical Products, Inc. |
| 384 Pratt St. |
|
Meriden,
CT
06450
|
|
| Correspondent Contact |
CHARLES A GARCIA |
| Regulation Number | 882.5890 |
| Classification Product Code |
|
| Date Received | 07/02/1985 |
| Decision Date | 08/28/1985 |
| 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
|
|
|