| 510(k) Number |
K791221 |
| Device Name |
TEGTMEIER MAMMOMETER |
| Applicant |
| Aztec Medical Products, Inc. |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Correspondent |
| Aztec Medical Products, Inc. |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Date Received | 07/03/1979 |
| Decision Date | 07/03/1979 |
| Decision |
SE - Postmarket Surveillance Required
(SESP) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|