| Device Classification Name |
Tray, Fluoride, Disposable
|
| 510(k) Number |
K904914 |
| Device Name |
DENTAL VACUUM INJECTION TRAY |
| Applicant |
| The Lebanon Vac-Tray Corp. |
| 905 N. Lebanon St. |
|
Lebanon,
IN
46052
|
|
| Applicant Contact |
TRAVIS H OSBORNE |
| Correspondent |
| The Lebanon Vac-Tray Corp. |
| 905 N. Lebanon St. |
|
Lebanon,
IN
46052
|
|
| Correspondent Contact |
TRAVIS H OSBORNE |
| Regulation Number | 872.6870 |
| Classification Product Code |
|
| Date Received | 10/31/1990 |
| Decision Date | 12/17/1990 |
| 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
|
|
|