The following data is part of a premarket notification filed by Novo Nordisk Inc. with the FDA for Novofine Plus 32g Tip X 4 Mm.
| Device ID | K202005 |
| 510k Number | K202005 |
| Device Name: | NovoFine Plus 32G Tip X 4 Mm |
| 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 | No |
| Date Received | 2020-07-21 |
| Decision Date | 2020-12-19 |