| 510(k) Number |
K855123 |
| Device Name |
KMW HIP PROSTHESIS POROUS COATED |
| Applicant |
| Kirkschner Medical Corp. |
| 10 W. Aylesbury Rd., |
| P.O. Box 218 |
|
Timonium,
MD
21093
|
|
| Applicant Contact |
SAM SON |
| Correspondent |
| Kirkschner Medical Corp. |
| 10 W. Aylesbury Rd., |
| P.O. Box 218 |
|
Timonium,
MD
21093
|
|
| Correspondent Contact |
SAM SON |
| Date Received | 12/23/1985 |
| Decision Date | 02/11/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Orthopedic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|