| 510(k) Number |
K842845 |
| Device Name |
BONE MILL BONE GRINDER |
| Applicant |
| Acromed Corp. |
| 2475 Est 22 St. |
| Suite 401 |
|
Cleveland ,
OH
44115
|
|
| Applicant Contact |
EDWARD J WAGNER |
| Correspondent |
| Acromed Corp. |
| 2475 Est 22 St. |
| Suite 401 |
|
Cleveland ,
OH
44115
|
|
| Correspondent Contact |
EDWARD J WAGNER |
| Date Received | 07/20/1984 |
| Decision Date | 10/25/1984 |
| 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
|
|
|