K102774 is an FDA 510(k) clearance for the VACUETTE QUICKSHIELD WITH SNAPPY TUDE HOLDER. 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 October 15, 2010, 21 days after receiving the submission on September 24, 2010.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K102774 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 24, 2010 |
| Decision Date | October 15, 2010 |
| Days to Decision | 21 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 |