The following data is part of a premarket notification filed by Novo Nordisk Inc. with the FDA for Novofine 32g Tip (0.23/0.25) X 6 Mm Etw (extra Thin Wall).
| Device ID | K173479 |
| 510k Number | K173479 |
| Device Name: | NovoFine 32G Tip (0.23/0.25) X 6 Mm ETW (extra Thin Wall) |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | Novo Nordisk Inc. P.O. Box 846 Plainsboro, NJ 08536 |
| Contact | Devraj Chakravarty |
| Correspondent | Devraj Chakravarty 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 | 2017-11-13 |
| Decision Date | 2018-01-17 |
| Summary: | summary |