The following data is part of a premarket notification filed by Flat Medical Co., Ltd. with the FDA for Epifaith Syringe (luer Slip) , Epifaith Syringe (nrfit).
| Device ID | K182268 |
| 510k Number | K182268 |
| Device Name: | EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit) |
| Classification | Syringe, Piston |
| Applicant | Flat Medical Co., Ltd. Rm. 1, 9F., No.27, Sec.1, Chang' An E. Rd., Zhongshan Dist. Taipei, TW 10441 |
| Contact | Shao-wei Tseng |
| Correspondent | Shao-wei Tseng Flat Medical Co., Ltd. Rm. 1, 9F., No.27, Sec.1, Chang' An E. Rd., Zhongshan Dist. Taipei, TW 10441 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-21 |
| Decision Date | 2019-04-05 |