The following data is part of a premarket notification filed by Mavig Gmbh with the FDA for M3.
| Device ID | K063333 |
| 510k Number | K063333 |
| Device Name: | M3 |
| Classification | Light, Surgical, Ceiling Mounted |
| Applicant | MAVIG GMBH STAHLGRUBERRING 5 Munchen, DE 81829 |
| Contact | Christian Stoian |
| Correspondent | Jeffery D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | FSY |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-11-06 |
| Decision Date | 2006-11-21 |
| Summary: | summary |