K050106 is an FDA 510(k) clearance for the NOVOFINE AUTOCOVER 30G X 8MM. 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 March 30, 2005, 71 days after receiving the submission on January 18, 2005.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K050106 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 18, 2005 |
| Decision Date | March 30, 2005 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| 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 |