| Device Classification Name |
Chair, Dental, With Operative Unit
|
| 510(k) Number |
K893945 |
| Device Name |
FD 350 DENTAL STOOL |
| Applicant |
| Oriola OY Finndent |
| 3 Willow Ridge |
|
Conroe,
TX
77304
|
|
| Applicant Contact |
JOHN R HOGAN |
| Correspondent |
| Oriola OY Finndent |
| 3 Willow Ridge |
|
Conroe,
TX
77304
|
|
| Correspondent Contact |
JOHN R HOGAN |
| Regulation Number | 872.6250 |
| Classification Product Code |
|
| Date Received | 05/31/1989 |
| Decision Date | 08/11/1989 |
| 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
|
|
|