The following data is part of a premarket notification filed by Novo Nordisk Inc. with the FDA for Novofine.
Device ID | K210258 |
510k Number | K210258 |
Device Name: | NovoFine |
Classification | Needle, Hypodermic, Single Lumen |
Applicant | Novo Nordisk Inc. P.O Box 846 Plainsboro, NJ 08536 |
Contact | Hiral Palkhiwala Shah |
Correspondent | Hiral Palkhiwala Shah Novo Nordisk Inc. P.O Box 846 Plainsboro, NJ 08536 |
Product Code | FMI |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2021-02-01 |
Decision Date | 2021-06-23 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() NOVOFINE 74113549 1738173 Live/Registered |
NOVO NORDISK A/S 1990-11-08 |