The following data is part of a premarket notification filed by Eli Lilly And Company with the FDA for Humapen Luxura.
Device ID | K142518 |
510k Number | K142518 |
Device Name: | HumaPen Luxura |
Classification | Syringe, Piston |
Applicant | ELI LILLY AND COMPANY LILLY CORPORATE CENTER Indianapolis, IN 46285 |
Contact | Leeann Chambers, Ms., Rac |
Correspondent | Leeann Chambers, Ms., Rac ELI LILLY AND COMPANY 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 | 2014-09-08 |
Decision Date | 2015-06-05 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
HUMAPEN LUXURA 78569420 3308394 Live/Registered |
Eli Lilly and Company 2005-02-17 |