The following data is part of a premarket notification filed by Medical Illumination International, Inc. with the FDA for Next General M20 Surgical Light; Next Generation M16 Minor Surgery Light; Next Generation Spotlight; Next Generation M8.
| Device ID | K003489 |
| 510k Number | K003489 |
| Device Name: | NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGERY LIGHT; NEXT GENERATION SPOTLIGHT; NEXT GENERATION M8 |
| Classification | Light, Surgical, Floor Standing |
| Applicant | MEDICAL ILLUMINATION INTERNATIONAL, INC. 547 LIBRARY ST. San Fernando, CA 91340 |
| Contact | David Glover |
| Correspondent | David Glover MEDICAL ILLUMINATION INTERNATIONAL, INC. 547 LIBRARY ST. San Fernando, CA 91340 |
| Product Code | FSS |
| Subsequent Product Code | FSY |
| Subsequent Product Code | FTD |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-13 |
| Decision Date | 2001-02-02 |