The following data is part of a premarket notification filed by Wuhan Zonsen Medical Products Co., Ltd with the FDA for Surgical Mask.
| Device ID | K202191 |
| 510k Number | K202191 |
| Device Name: | Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | Wuhan Zonsen Medical Products Co., Ltd Chengbei Industry Zone, Zhucheng Avenue, Xinzhou District Wuhan, CN 431000 |
| Contact | Shirly Xi |
| 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 | 2020-08-05 |
| Decision Date | 2021-03-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B754BFM0011 | K202191 | 000 |
| 20850044458916 | K202191 | 000 |
| 20850044458909 | K202191 | 000 |
| 00850046814471 | K202191 | 000 |
| 00850037921164 | K202191 | 000 |