The following data is part of a premarket notification filed by Eli Lilly And Company with the FDA for Humapen Luxura Hd.
| Device ID | K100988 |
| 510k Number | K100988 |
| Device Name: | HUMAPEN LUXURA HD |
| Classification | Syringe, Piston |
| Applicant | ELI LILLY AND COMPANY LILLY CORPORATE CENTER Indianapolis, IN 46285 |
| Contact | Steven T Johnson Pe, Mba |
| Correspondent | Steven T Johnson Pe, Mba 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 | 2010-04-09 |
| Decision Date | 2010-08-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30300029675014 | K100988 | 000 |
| 00300029673019 | K100988 | 000 |