| 510(k) Number |
K854339 |
| Device Name |
CUI CHIN SIZER |
| Applicant |
| Cox-Uphuff Intl. |
| 725 E. Yanonali St. |
|
Santa Barbara,
CA
93103
|
|
| Applicant Contact |
DAVID J SCHUESSLER |
| Correspondent |
| Cox-Uphuff Intl. |
| 725 E. Yanonali St. |
|
Santa Barbara,
CA
93103
|
|
| Correspondent Contact |
DAVID J SCHUESSLER |
| Date Received | 10/28/1985 |
| Decision Date | 11/15/1985 |
| 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
|
|
|