The following data is part of a premarket notification filed by Pac-dent, Inc. with the FDA for The Imask Child's Face Mask.
| Device ID | K202831 |
| 510k Number | K202831 |
| Device Name: | The IMask Child's Face Mask |
| Classification | Pediatric/child Facemask |
| Applicant | Pac-Dent, Inc. 670 Endeavor Circle Brea, CA 92821 |
| Contact | Jiahe Li |
| Correspondent | Dong He Pac-Dent, Inc. 670 Endeavor Circle Brea, CA 92821 |
| Product Code | OXZ |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-25 |
| Decision Date | 2021-08-26 |