K163093 is an FDA 510(k) clearance for the Safety Blood Collection Set. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Jiangsu Shenli Medical Production Co., Ltd. (Changzhou City, CN). The FDA issued a Cleared decision on March 14, 2017, 130 days after receiving the submission on November 4, 2016.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K163093 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 04, 2016 |
| Decision Date | March 14, 2017 |
| Days to Decision | 130 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 |