The following data is part of a premarket notification filed by Pac-dent, Inc. with the FDA for Imask Disposable Surgical Face Mask.
| Device ID | K201182 |
| 510k Number | K201182 |
| Device Name: | IMask Disposable Surgical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Pac-Dent, Inc. 670 Endeavor Circle Brea, CA 92821 |
| Contact | Jiahe Li |
| Correspondent | Jiahe Li Pac-Dent, Inc. 670 Endeavor Circle Brea, CA 92821 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-01 |
| Decision Date | 2021-02-19 |