The following data is part of a premarket notification filed by Eli Lilly And Company with the FDA for Humapen Memoir.
Device ID | K053563 |
510k Number | K053563 |
Device Name: | HUMAPEN MEMOIR |
Classification | Syringe, Piston |
Applicant | ELI LILLY AND COMPANY LILLY CORPORATE CENTER Indianapolis, IN 46285 |
Contact | Leeann Chambers |
Correspondent | Leeann Chambers 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 | No |
Date Received | 2005-12-21 |
Decision Date | 2006-04-07 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
HUMAPEN MEMOIR 78569425 3298949 Dead/Cancelled |
Eli Lilly and Company 2005-02-17 |