K201930 is an FDA 510(k) clearance for the Nanum Syringe. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Nanum Company Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on January 17, 2021, 191 days after receiving the submission on July 10, 2020.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K201930 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 10, 2020 |
| Decision Date | January 17, 2021 |
| Days to Decision | 191 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FMF - Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |