| Device Classification Name |
Plate, Bone
|
| 510(k) Number |
K943345 |
| Device Name |
MANUAL SURGICAL INST. AND ACC. TO KLS CHIN PLATE SYSTEM |
| Applicant |
| Patton, Boggs & Blow |
| 2550 M St. NW |
|
Washington,
DC
20037
|
|
| Applicant Contact |
MARK A HELLER |
| Correspondent |
| Patton, Boggs & Blow |
| 2550 M St. NW |
|
Washington,
DC
20037
|
|
| Correspondent Contact |
MARK A HELLER |
| Regulation Number | 872.4760 |
| Classification Product Code |
|
| Date Received | 07/12/1994 |
| Decision Date | 10/04/1994 |
| 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
|
|
|