K182268 is an FDA 510(k) clearance for the EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit). This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Flat Medical Co., Ltd. (Taipei, TW). The FDA issued a Cleared decision on April 5, 2019, 227 days after receiving the submission on August 21, 2018.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K182268 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 21, 2018 |
| Decision Date | April 05, 2019 |
| Days to Decision | 227 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMF - Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |