The following data is part of a premarket notification filed by Hubei Kangning Protective Products Co., Ltd. with the FDA for Medical Face Mask.
| Device ID | K211363 |
| 510k Number | K211363 |
| Device Name: | Medical Face Mask |
| Classification | Mask, Surgical |
| Applicant | HuBei Kangning Protective Products Co., Ltd. Special No1, Xuefu Road, Xiantao City, Hubei , China Xiantao, CN 433000 |
| Contact | Zhao Yuxuan |
| Correspondent | Ivy Wang Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shangghai, 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 | 2021-05-03 |
| Decision Date | 2021-07-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10898302140190 | K211363 | 000 |