| Device Classification Name |
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
|
| 510(k) Number |
K900051 |
| Device Name |
MOORE TYPE ENDO PROSTHESIS |
| Applicant |
| Lima Intl. Corp. |
| 392 Wampanoag Trl. |
|
E Providence,
RI
02915
|
|
| Applicant Contact |
POLLONIO-LISTER |
| Correspondent |
| Lima Intl. Corp. |
| 392 Wampanoag Trl. |
|
E Providence,
RI
02915
|
|
| Correspondent Contact |
POLLONIO-LISTER |
| Regulation Number | 888.3390 |
| Classification Product Code |
|
| Date Received | 01/03/1990 |
| Decision Date | 10/03/1990 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Orthopedic
|
| 510k Review Panel |
Orthopedic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|