The following data is part of a premarket notification filed by Trumpf Kreuzer Medizin Systeme Gmbh + Co.kg with the FDA for Trulight 5520 And Trulight 5320.
| Device ID | K102758 |
| 510k Number | K102758 |
| Device Name: | TRULIGHT 5520 AND TRULIGHT 5320 |
| Classification | Light, Surgical, Ceiling Mounted |
| Applicant | TRUMPF KREUZER MEDIZIN SYSTEME GMBH + CO.KG 1046 LEGRAND BOULEVARD Charleston, SC 29492 |
| Contact | Lindsey Ronnenberg |
| Correspondent | Jeff D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | FSY |
| Subsequent Product Code | FQP |
| Subsequent Product Code | FSQ |
| Subsequent Product Code | FTD |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-09-23 |
| Decision Date | 2010-10-26 |
| Summary: | summary |