NovoFine
Needle, Hypodermic, Single Lumen
Novo Nordisk Inc.
The following data is part of a premarket notification filed by Novo Nordisk Inc. with the FDA for Novofine.
Pre-market Notification Details
| 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 |
Trademark Results [NovoFine]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NOVOFINE 74113549 1738173 Live/Registered |
NOVO NORDISK A/S 1990-11-08 |
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