| Device Classification Name |
Cement, Dental
|
| 510(k) Number |
K930116 |
| Device Name |
LCL 8 |
| Applicant |
| Voco GmbH |
| 7527 Westmoreland Ave. |
|
St Louis,
MO
63105
|
|
| Applicant Contact |
EVAN G DICK |
| Correspondent |
| Voco GmbH |
| 7527 Westmoreland Ave. |
|
St Louis,
MO
63105
|
|
| Correspondent Contact |
EVAN G DICK |
| Regulation Number | 872.3275 |
| Classification Product Code |
|
| Date Received | 01/11/1993 |
| Decision Date | 06/17/1993 |
| 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
|
|
|