The following data is part of a premarket notification filed by Zhende Medical Co., Ltd with the FDA for Medical Mask.
| Device ID | K201729 |
| 510k Number | K201729 |
| Device Name: | Medical Mask |
| Classification | Mask, Surgical |
| Applicant | Zhende Medical Co., Ltd Gaobu Town Shaoxing, CN 312035 |
| Contact | Chen Ming |
| Correspondent | Ivy Wang Shanghai Sungo Management Consulting Company Limited 13th 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 | 2020-06-24 |
| Decision Date | 2020-12-03 |