HumaPen Luxura
Syringe, Piston
ELI LILLY AND COMPANY
The following data is part of a premarket notification filed by Eli Lilly And Company with the FDA for Humapen Luxura.
Pre-market Notification Details
| Device ID | K142518 |
| 510k Number | K142518 |
| Device Name: | HumaPen Luxura |
| Classification | Syringe, Piston |
| Applicant | ELI LILLY AND COMPANY LILLY CORPORATE CENTER Indianapolis, IN 46285 |
| Contact | Leeann Chambers, Ms., Rac |
| Correspondent | Leeann Chambers, Ms., Rac ELI LILLY AND COMPANY LILLY CORPORATE CENTER Indianapolis, IN 46285 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2014-09-08 |
| Decision Date | 2015-06-05 |
| Summary: | summary |
Trademark Results [HumaPen Luxura]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HUMAPEN LUXURA 78569420 3308394 Live/Registered |
Eli Lilly and Company 2005-02-17 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.