The following data is part of a premarket notification filed by Medtecs (taiwan) Corp. with the FDA for Astm Level 1/en14683 Type Iir 3-ply Disposable Surgical Mask, Model Number: Fm-1400g.
| Device ID | K203376 |
| 510k Number | K203376 |
| Device Name: | ASTM Level 1/EN14683 Type IIR 3-Ply Disposable Surgical Mask, Model Number: FM-1400G |
| Classification | Mask, Surgical |
| Applicant | Medtecs (Taiwan) Corp. 11F., No. 9, Songgao Road, Xinyi Dist. Taipei City, TW 11073 |
| Contact | William Yang |
| Correspondent | Sandy Liu Jin Services Co. 9F-1, No13, Lane41, Zhangrong Rd, Sec. 5, North District Tainan City, TW 70447 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-17 |
| Decision Date | 2022-03-02 |