The following data is part of a premarket notification filed by Medical Illumination, Inc. with the FDA for Mi-15 Exam Surgical Light.
| Device ID | K930897 |
| 510k Number | K930897 |
| Device Name: | MI-15 EXAM SURGICAL LIGHT |
| Classification | Lamp, Surgical |
| Applicant | MEDICAL ILLUMINATION, INC. 12734 BRANFORD ST. UNIT 1 & 2 Arleta, CA 91331 |
| Contact | Hollar |
| Correspondent | Hollar MEDICAL ILLUMINATION, INC. 12734 BRANFORD ST. UNIT 1 & 2 Arleta, CA 91331 |
| Product Code | FTD |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-22 |
| Decision Date | 1993-06-25 |