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 |