K053470 is an FDA 510(k) clearance for the NOVOFINE 32G TIP. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Novo Nordisk, Inc. (Princeton, US). The FDA issued a Cleared decision on December 21, 2005, 7 days after receiving the submission on December 14, 2005.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K053470 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 14, 2005 |
| Decision Date | December 21, 2005 |
| Days to Decision | 7 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMI - Needle, Hypodermic, Single Lumen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5570 |