The following data is part of a premarket notification filed by Eli Lilly And Co. with the FDA for Humapen And Humapen Ergo.
| Device ID | K982842 |
| 510k Number | K982842 |
| Device Name: | HUMAPEN AND HUMAPEN ERGO |
| Classification | Syringe, Piston |
| Applicant | ELI LILLY AND CO. LILLY CORPORATE CENTER DROP CODE 4002 Indianapolis, IN 46285 |
| Contact | Leeann Chambers |
| Correspondent | Leeann Chambers ELI LILLY AND CO. LILLY CORPORATE CENTER DROP CODE 4002 Indianapolis, IN 46285 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-12 |
| Decision Date | 1998-09-25 |
| Summary: | summary |