| 510(k) Number |
K810271 |
| Device Name |
DIRECT CURRENT BONE GROWTH STIM. AN. PAD |
| Applicant |
| Andover Medical, Inc. |
| 4221 Richmond Rd., NW |
|
Walker,
MI
49534
|
|
| Correspondent |
| Andover Medical, Inc. |
| 4221 Richmond Rd., NW |
|
Walker,
MI
49534
|
|
| Date Received | 02/02/1981 |
| Decision Date | 02/19/1981 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Toxicology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|