The following data is part of a premarket notification filed by Chuzhou Daddy's Choice Science And Technology Co., Ltd. with the FDA for Purism Disposable Surgical Mask.
| Device ID | K210856 |
| 510k Number | K210856 |
| Device Name: | Purism Disposable Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | Chuzhou Daddy's Choice Science And Technology Co., Ltd. Middle Of Nanjing Road, Langya District Chuzhou, CN 239000 |
| Contact | Amie Yang |
| Correspondent | Nickita Alexiades mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, NY 11021 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-23 |
| Decision Date | 2021-07-28 |