The following data is part of a premarket notification filed by Eli Lilly And Company with the FDA for Go Dose System.
| Device ID | K160949 |
| 510k Number | K160949 |
| Device Name: | Go Dose System |
| Classification | Calculator, Drug Dose |
| Applicant | ELI LILLY AND COMPANY LILLY CORPORATE CENTER Indianapolis, IN 46285 |
| Contact | Sumitra M Ghate |
| Correspondent | Sumitra M Ghate ELI LILLY AND COMPANY LILLY CORPORATE CENTER Indianapolis, IN 46285 |
| Product Code | NDC |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-05 |
| Decision Date | 2016-12-22 |
| Summary: | summary |