The following data is part of a premarket notification filed by Changzhou Holymed Products Co., Ltd. with the FDA for Surgical Mask.
| Device ID | K210524 |
| 510k Number | K210524 |
| Device Name: | Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | Changzhou Holymed Products Co., Ltd. 525 Changwu Road South Changzhou, CN 213167 |
| Contact | Shan Shang |
| Correspondent | Shan Shang Changzhou Holymed Products Co., Ltd. 525 Changwu Road South Changzhou, CN 213167 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-23 |
| Decision Date | 2021-07-07 |