| Device Classification Name |
Device, Medical Examination, Ac Powered
|
| 510(k) Number |
K922281 |
| Device Name |
ILLUMINATOR VII MINI/SPOT LIGHT |
| Applicant |
| Medical Illumination, Inc. |
| 12734 Branford St. |
| Unit 1 & 2 |
|
Arleta,
CA
91331
|
|
| Correspondent |
| Medical Illumination, Inc. |
| 12734 Branford St. |
| Unit 1 & 2 |
|
Arleta,
CA
91331
|
|
| Regulation Number | 880.6320 |
| Classification Product Code |
|
| Date Received | 05/15/1992 |
| Decision Date | 02/05/1993 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|