| Device Classification Name |
Handpiece, Air-Powered, Dental
|
| 510(k) Number |
K925378 |
| Device Name |
STERI-SOL SOLUTION, MODIFICATION |
| Applicant |
| Anodia Systems |
| 514 S. Third St. |
|
Danville,
KY
40422
|
|
| Applicant Contact |
THAD J OVERMYER |
| Correspondent |
| Anodia Systems |
| 514 S. Third St. |
|
Danville,
KY
40422
|
|
| Correspondent Contact |
THAD J OVERMYER |
| Regulation Number | 872.4200 |
| Classification Product Code |
|
| Date Received | 10/06/1992 |
| Decision Date | 07/22/1993 |
| 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
|
|
|