The following data is part of a premarket notification filed by Trumpf Medizin Systeme Gmbh + Co. Kg with the FDA for Iled 3 Mobile (i300m), Trulight 5500 Mobile (t500m), Trulight 5300 Mobile (t300m).
| Device ID | K091246 |
| 510k Number | K091246 |
| Device Name: | ILED 3 MOBILE (I300M), TRULIGHT 5500 MOBILE (T500M), TRULIGHT 5300 MOBILE (T300M) |
| Classification | Light, Surgical, Floor Standing |
| Applicant | TRUMPF MEDIZIN SYSTEME GMBH + CO. KG 415 JESSEN LN. Charleston, SC 29492 |
| Contact | Lindsey Hengel |
| Correspondent | Lindsey Hengel TRUMPF MEDIZIN SYSTEME GMBH + CO. KG 415 JESSEN LN. Charleston, SC 29492 |
| Product Code | FSS |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-27 |
| Decision Date | 2009-09-28 |
| Summary: | summary |