The following data is part of a premarket notification filed by Eli Lilly And Company, Inc. with the FDA for Humapen Savvio.
| Device ID | K160668 |
| 510k Number | K160668 |
| Device Name: | HumaPen Savvio |
| Classification | Syringe, Piston |
| Applicant | Eli Lilly And Company, Inc. Lilly Corporate Center Indianapolis, IN 46285 |
| Contact | Christine A. Phliips |
| Correspondent | Kevin S. Bardonner 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 | No |
| Date Received | 2016-03-09 |
| Decision Date | 2016-06-03 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() HUMAPEN SAVVIO 87026517 not registered Live/Pending |
Eli Lilly and Company 2016-05-05 |
![]() HUMAPEN SAVVIO 85767187 not registered Dead/Abandoned |
Eli Lilly and Company 2012-10-30 |