The following data is part of a premarket notification filed by Savewo Limited with the FDA for Savewo Classicmask.
| Device ID | K221957 |
| 510k Number | K221957 |
| Device Name: | Savewo ClassicMASK |
| Classification | Mask, Surgical |
| Applicant | Savewo Limited 1/F & 2/F, 266-270 Texaco Road, Tsuen Wan Hong Kong, CN 0000 |
| Contact | Melanie Choi |
| Correspondent | Ivy Lai Long Jing Technology Ltd. 17th Chung Pont Commercial Building, 300 Hennessy Road Hong Kong, CN 0000 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-05 |
| Decision Date | 2022-09-02 |