The following data is part of a premarket notification filed by Wuhan Dymex Healthcare Co., Ltd with the FDA for Surgical Face Mask.
| Device ID | K182515 |
| 510k Number | K182515 |
| Device Name: | Surgical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Wuhan Dymex Healthcare Co., Ltd Room 1701, Unit 2, Building 5, Jingsegangwan Phase 5, Dongfeng Avenus Wuhan, CN 430000 |
| Contact | Ada Liu |
| Correspondent | Ivy Wang Shanghai Sungo Management Consulting Company Limited 4th Floor, 1500# Central Avenue Shanghai, CN 200122 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-12 |
| Decision Date | 2019-05-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10840216109022 | K182515 | 000 |
| 10840216109015 | K182515 | 000 |
| 10840216108995 | K182515 | 000 |
| 10840216108971 | K182515 | 000 |
| 10840216108964 | K182515 | 000 |
| 10840216108940 | K182515 | 000 |
| 10840216108735 | K182515 | 000 |
| 10840216110929 | K182515 | 000 |