| Device Classification Name |
Illuminator, Radiographic-Film
|
| 510(k) Number |
K883702 |
| Device Name |
EXCELVIEW ILLUMINATOR |
| Applicant |
| Excel Medical Products, Inc. |
| 2610-4 W. Marshall Dr. |
|
Grand Prairie,
TX
75051
|
|
| Applicant Contact |
SCOTT T JONES |
| Correspondent |
| Excel Medical Products, Inc. |
| 2610-4 W. Marshall Dr. |
|
Grand Prairie,
TX
75051
|
|
| Correspondent Contact |
SCOTT T JONES |
| Regulation Number | 892.1890 |
| Classification Product Code |
|
| Date Received | 08/30/1988 |
| Decision Date | 09/19/1988 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Radiology
|
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|