| 510(k) Number |
K871138 |
| Device Name |
FOUNDATIONS PLUS ABDOMINAL BAND 1100 |
| Applicant |
| Foundations Plus, Inc. |
| 1008 Tinker Rd. |
|
Colleyville,
TX
76034
|
|
| Applicant Contact |
DIETRICH USREY |
| Correspondent |
| Foundations Plus, Inc. |
| 1008 Tinker Rd. |
|
Colleyville,
TX
76034
|
|
| Correspondent Contact |
DIETRICH USREY |
| Date Received | 03/23/1987 |
| Decision Date | 04/23/1987 |
| Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|