| 510(k) Number |
K851409 |
| Device Name |
UNILOC TOTAL HIP PROSTHESIS |
| Applicant |
| Serrano Intl. |
| Two Century Plz. |
| Suite 1200 |
|
Los Angeles,
CA
90067
|
|
| Applicant Contact |
JAY H GELLER |
| Correspondent |
| Serrano Intl. |
| Two Century Plz. |
| Suite 1200 |
|
Los Angeles,
CA
90067
|
|
| Correspondent Contact |
JAY H GELLER |
| Date Received | 04/09/1985 |
| Decision Date | 11/22/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Orthopedic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|