| 510(k) Number |
K864018 |
| Device Name |
HACKSAW |
| Applicant |
| Med-Tool, Inc. |
| 12434 Matthews Ln. |
|
St. Louis,
MO
63127
|
|
| Applicant Contact |
MAYERIK, JR. |
| Correspondent |
| Med-Tool, Inc. |
| 12434 Matthews Ln. |
|
St. Louis,
MO
63127
|
|
| Correspondent Contact |
MAYERIK, JR. |
| Date Received | 10/15/1986 |
| Decision Date | 10/30/1986 |
| 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
|
|
|