The following data is part of a premarket notification filed by Eli Lilly And Company, Inc. with the FDA for Humanpen Ergo Ii.
| Device ID | K151686 |
| 510k Number | K151686 |
| Device Name: | HumanPen Ergo II |
| Classification | Syringe, Piston |
| Applicant | ELI LILLY AND COMPANY, INC. LILLY CORPORATE CENTER Indianapolis, IN 46285 |
| Contact | Christine A. Phillips |
| Correspondent | Christine A. Phillips ELI LILLY AND COMPANY, INC. 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 | 2015-06-23 |
| Decision Date | 2015-12-30 |