The following data is part of a premarket notification filed by Crown Name Disposable Hygiene Products Fty., Ltd. with the FDA for Surgical Face Mask (model: Flat Ear Loop/cn102).
| Device ID | K203534 |
| 510k Number | K203534 |
| Device Name: | Surgical Face Mask (Model: Flat Ear Loop/CN102) |
| Classification | Mask, Surgical |
| Applicant | Crown Name Disposable Hygiene Products Fty., Ltd. Chengbei Industrial Zone, Zhucheng Ave, Xinzhou District Wuhan, CN 431400 |
| Contact | Ying Fang |
| Correspondent | Ying Fang Crown Name Disposable Hygiene Products Fty., Ltd. Chengbei Industrial Zone, Zhucheng Ave, Xinzhou District Wuhan, CN 431400 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-02 |
| Decision Date | 2021-07-21 |