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 |