The following data is part of a premarket notification filed by Flat Medical Co., Ltd with the FDA for Epifaith Syringe.
| Device ID | K192421 |
| 510k Number | K192421 |
| Device Name: | EpiFaith Syringe |
| Classification | Syringe, Piston |
| Applicant | Flat Medical Co., Ltd 9F-1., No27, Sec.1, Chang' An E. Rd., Zhongshan Dist., Taipei 10441, Taiwan Taipei, TW 10441 |
| Contact | Shao Wei Tseng |
| Correspondent | Shao Wei Tseng Flat Medical Co., Ltd 9F-1., No27, Sec.1, Chang' An E. Rd., Zhongshan Dist., Taipei 10441, Taiwan Taipei, TW 10441 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-04 |
| Decision Date | 2019-09-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 44719875599024 | K192421 | 000 |
| 44719875599017 | K192421 | 000 |
| 14719875599023 | K192421 | 000 |
| 14719875599016 | K192421 | 000 |
| 14719875599061 | K192421 | 000 |