| 510(k) Number |
K864508 |
| Device Name |
HOWSE II TOTAL HIP REPLACEMENT SYSTEM |
| Applicant |
| Johnson & Johnson Professionals, Inc. |
| Brunel Way |
| Slough, Berks |
|
England,
GB
SL1 IXR
|
|
| Applicant Contact |
ALISON J HOWITT |
| Correspondent |
| Johnson & Johnson Professionals, Inc. |
| Brunel Way |
| Slough, Berks |
|
England,
GB
SL1 IXR
|
|
| Correspondent Contact |
ALISON J HOWITT |
| Date Received | 11/14/1986 |
| Decision Date | 12/09/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Orthopedic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|