| Device Classification Name |
System, X-Ray, Extraoral Source, Digital
|
| 510(k) Number |
K990002 |
| Device Name |
QUICKRAY DSX 730 |
| Applicant |
| Julie Alliance |
| 1095 Mason Ave. |
|
Daytona Beach,
FL
32117
|
|
| Applicant Contact |
CLAUDE D BERHOIN |
| Correspondent |
| Julie Alliance |
| 1095 Mason Ave. |
|
Daytona Beach,
FL
32117
|
|
| Correspondent Contact |
CLAUDE D BERHOIN |
| Regulation Number | 872.1800 |
| Classification Product Code |
|
| Date Received | 01/04/1999 |
| Decision Date | 04/01/1999 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Dental
|
| 510k Review Panel |
Radiology
|
| Statement |
Statement
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|