| Device Classification Name |
Accessories, Retractor, Dental
|
| 510(k) Number |
K940785 |
| Device Name |
MOUTH PROPS |
| Applicant |
| Worldwide Dental, Inc. |
| 12890 Automobile Blvd., |
| Suite A |
|
Clearwater,
FL
34622 -4733
|
|
| Applicant Contact |
WILLIAM M DOMIN |
| Correspondent |
| Worldwide Dental, Inc. |
| 12890 Automobile Blvd., |
| Suite A |
|
Clearwater,
FL
34622 -4733
|
|
| Correspondent Contact |
WILLIAM M DOMIN |
| Regulation Number | 872.4565 |
| Classification Product Code |
|
| Date Received | 02/22/1994 |
| Decision Date | 10/05/1994 |
| 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
|
|
|