The following data is part of a premarket notification filed by Medical Illumination International, Inc. with the FDA for Mi-750 Procedural/minor Surgical Light.
| Device ID | K140812 |
| 510k Number | K140812 |
| Device Name: | MI-750 PROCEDURAL/MINOR SURGICAL LIGHT |
| Classification | Light, Surgical, Ceiling Mounted |
| Applicant | MEDICAL ILLUMINATION INTERNATIONAL, INC. 547 LIBRARY ST. San Fernando, CA 91340 |
| Contact | Robert Hess |
| Correspondent | Robert Hess MEDICAL ILLUMINATION INTERNATIONAL, INC. 547 LIBRARY ST. San Fernando, CA 91340 |
| Product Code | FSY |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-01 |
| Decision Date | 2014-08-07 |
| Summary: | summary |