| 510(k) Number |
K843778 |
| Device Name |
MAYO ELBOW II |
| Applicant |
| Zimmer, Inc. |
| P.O. Box 708 |
|
Warsaw,
IN
46581
|
|
| Applicant Contact |
HENRY A QUELLO |
| Correspondent |
| Zimmer, Inc. |
| P.O. Box 708 |
|
Warsaw,
IN
46581
|
|
| Correspondent Contact |
HENRY A QUELLO |
| Date Received | 09/25/1984 |
| Decision Date | 03/05/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Orthopedic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|