| 510(k) Number |
K863754 |
| Device Name |
FOUNDATIONS PLUS FACIAL-CHIN-NECK SUPPORTER 1000 |
| 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 | 09/25/1986 |
| Decision Date | 10/17/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|