| 510(k) Number |
K863854 |
| Device Name |
P.M.D. INTRAMEDULLARY CEMENT RESTRICTOR PLUG |
| Applicant |
| Precision Medical Devices, Inc. |
| 1400 Mrket St. Suite 101 |
|
Camp Hill,
PA
17011
|
|
| Applicant Contact |
EVERHART, JR. |
| Correspondent |
| Precision Medical Devices, Inc. |
| 1400 Mrket St. Suite 101 |
|
Camp Hill,
PA
17011
|
|
| Correspondent Contact |
EVERHART, JR. |
| Date Received | 10/02/1986 |
| Decision Date | 11/19/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Orthopedic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|