The following data is part of a premarket notification filed by Kenpax International Limited with the FDA for Procedure Mask, Surgical Mask.
| Device ID | K202899 |
| 510k Number | K202899 |
| Device Name: | Procedure Mask, Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | Kenpax International Limited Flat 5, 5/F, Wing On Plaza, 62 Mody Road Tsim Sha Tsui, Kowloon Hong Kong, CN |
| Contact | Solomon Chen |
| Correspondent | Ivy Wang Shanghai Sungo Management Consulting Company Limited 14th 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 | 2020-09-29 |
| Decision Date | 2021-05-20 |