| 510(k) Number |
K860207 |
| Device Name |
S-ROM 135 POROUS COATED FEMORAL STEM COLLAR |
| Applicant |
| Joint Medical Products Corp. |
| 860 Canal St. |
|
Stamford,
CT
06902
|
|
| Applicant Contact |
DOUGLAS G NOILES |
| Correspondent |
| Joint Medical Products Corp. |
| 860 Canal St. |
|
Stamford,
CT
06902
|
|
| Correspondent Contact |
DOUGLAS G NOILES |
| Date Received | 01/22/1986 |
| Decision Date | 08/06/1986 |
| Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
| 510k Review Panel |
Orthopedic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|