K152606 is an FDA 510(k) clearance for the Jeesung Safety Syringe and Single Use Needles. This device is classified as a Syringe, Antistick (Class II - Special Controls, product code MEG).
Submitted by Jeesung Medical Co., Ltd. (Daejeon, KR). The FDA issued a Cleared decision on June 28, 2016, 291 days after receiving the submission on September 11, 2015.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K152606 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 11, 2015 |
| Decision Date | June 28, 2016 |
| Days to Decision | 291 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MEG - Syringe, Antistick |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |