| 510(k) Number |
K852555 |
| Device Name |
SPLINTREX |
| Applicant |
| Allison Forge Corp. |
| P.O. Box 767 |
|
Brookline,
MA
02146
|
|
| Applicant Contact |
PHILIP R LICHTMAN |
| Correspondent |
| Allison Forge Corp. |
| P.O. Box 767 |
|
Brookline,
MA
02146
|
|
| Correspondent Contact |
PHILIP R LICHTMAN |
| Date Received | 06/17/1985 |
| Decision Date | 06/28/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|