| 510(k) Number |
K862752 |
| Device Name |
C.S.M. HIP |
| Applicant |
| Protek, Inc. |
| 5780 W. 71st St. |
|
Indianapolis,
IN
46278
|
|
| Applicant Contact |
KENNETH EPLING |
| Correspondent |
| Protek, Inc. |
| 5780 W. 71st St. |
|
Indianapolis,
IN
46278
|
|
| Correspondent Contact |
KENNETH EPLING |
| Date Received | 07/22/1986 |
| Decision Date | 08/07/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Orthopedic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|