K121908 is an FDA 510(k) clearance for the SAFETY INFUSION SET. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Greiner Bio-One North America, Inc. (Baldwin, US). The FDA issued a Cleared decision on July 25, 2012, 26 days after receiving the submission on June 29, 2012.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K121908 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 29, 2012 |
| Decision Date | July 25, 2012 |
| Days to Decision | 26 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 |