The following data is part of a premarket notification filed by Novo Nordisk Inc. with the FDA for Novofine 32g Tip.
| Device ID | K053470 |
| 510k Number | K053470 |
| Device Name: | NOVOFINE 32G TIP |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | NOVO NORDISK INC. 100 COLLEGE ROAD WEST Princeton, NJ 08540 |
| Contact | John Signorin |
| Correspondent | John Signorin NOVO NORDISK INC. 100 COLLEGE ROAD WEST Princeton, NJ 08540 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-14 |
| Decision Date | 2005-12-21 |
| Summary: | summary |