| 510(k) Number |
K855148 |
| Device Name |
THARIES FIBER |
| Applicant |
| Zimmer, Inc. |
| P.O. Box 708 |
|
Warsaw,
IN
46581
|
|
| Applicant Contact |
MAX SHERMAN |
| Correspondent |
| Zimmer, Inc. |
| P.O. Box 708 |
|
Warsaw,
IN
46581
|
|
| Correspondent Contact |
MAX SHERMAN |
| Date Received | 12/26/1985 |
| Decision Date | 02/18/1986 |
| Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
| 510k Review Panel |
Orthopedic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|