The following data is part of a premarket notification filed by Intai Technology Corp. with the FDA for Intai Surgical Mask (non-sterile).
| Device ID | K210422 |
| 510k Number | K210422 |
| Device Name: | INTAI Surgical Mask (non-sterile) |
| Classification | Mask, Surgical |
| Applicant | INTAI Technology Corp. No. 9, Jingke Rd., Nantun Dist., TW 40852 |
| Contact | Dale Chang |
| Correspondent | Kevin Wang INTAI Technology Corp. No. 9, Jingke Rd., Nantun District Taichung, TW 40852 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-11 |
| Decision Date | 2022-03-30 |