The following data is part of a premarket notification filed by Novo Nordisk Inc. with the FDA for Novofine Plus 32g 4 Mm.
| Device ID | K133738 |
| 510k Number | K133738 |
| Device Name: | NOVOFINE PLUS 32G 4 MM |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | NOVO NORDISK INC. P.O. BOX 846 Plainsboro, NJ 08536 |
| Contact | Rick Spring |
| Correspondent | Rick Spring 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 | 2013-12-09 |
| Decision Date | 2014-05-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30301691858514 | K133738 | 000 |
| 30301691858507 | K133738 | 000 |
| 30301691856510 | K133738 | 000 |
| 30301691856503 | K133738 | 000 |
| 30301691855919 | K133738 | 000 |
| 30301691855506 | K133738 | 000 |