| Device Classification Name |
Chair, Dental, With Operative Unit
|
| 510(k) Number |
K942870 |
| Device Name |
ULTIMA 2 DENTAL CHAIR |
| Applicant |
| Dentech Corp. |
| 529 W. Front St. |
|
Sumas,
WA
98295
|
|
| Applicant Contact |
GARY VILLETTE |
| Correspondent |
| Dentech Corp. |
| 529 W. Front St. |
|
Sumas,
WA
98295
|
|
| Correspondent Contact |
GARY VILLETTE |
| Regulation Number | 872.6250 |
| Classification Product Code |
|
| Date Received | 06/17/1994 |
| Decision Date | 02/27/1995 |
| 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
|
|
|