The following data is part of a premarket notification filed by Novo Nordisk Inc. with the FDA for Flexpen Needle.
| Device ID | K090111 |
| 510k Number | K090111 |
| Device Name: | FLEXPEN NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | NOVO NORDISK INC. 100 COLLEGE ROAD WEST Princeton, NJ 08540 -7810 |
| Contact | Rick Spring |
| Correspondent | Rick Spring NOVO NORDISK INC. 100 COLLEGE ROAD WEST Princeton, NJ 08540 -7810 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-16 |
| Decision Date | 2010-02-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30301691851973 | K090111 | 000 |
| 30301691851898 | K090111 | 000 |