| 510(k) Number |
K850255 |
| Device Name |
DOW CORNING WRIGHT TITANIUM WRIST JOINT GROMMET |
| Applicant |
| Dow Corning Corp. Healthcare Industries Materials |
| Technical Service & Developmen |
|
Hemlock,
MI
48626
|
|
| Applicant Contact |
ELDON E FRISCH |
| Correspondent |
| Dow Corning Corp. Healthcare Industries Materials |
| Technical Service & Developmen |
|
Hemlock,
MI
48626
|
|
| Correspondent Contact |
ELDON E FRISCH |
| Date Received | 01/22/1985 |
| Decision Date | 05/01/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Orthopedic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|