| Device Classification Name |
Driver, Wire, And Bone Drill, Manual
|
| 510(k) Number |
K871834 |
| Device Name |
DRILL, HAND, BONE, SMEDBERG |
| Applicant |
| Military Engineering, Inc. |
| P.O. Box J 2135 Western |
| Ave. |
|
Plymouth,
IN
46563
|
|
| Applicant Contact |
ROBERT W FRANCIS |
| Correspondent |
| Military Engineering, Inc. |
| P.O. Box J 2135 Western |
| Ave. |
|
Plymouth,
IN
46563
|
|
| Correspondent Contact |
ROBERT W FRANCIS |
| Regulation Number | 872.4120 |
| Classification Product Code |
|
| Date Received | 05/12/1987 |
| Decision Date | 07/31/1987 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Dental
|
| 510k Review Panel |
Dental
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|