The following data is part of a premarket notification filed by Wuhan Zonsen Medical Products Co.,ltd with the FDA for Surgical Gown, Reinforced Surgical Gown.
| Device ID | K212861 |
| 510k Number | K212861 |
| Device Name: | Surgical Gown, Reinforced Surgical Gown |
| Classification | Gown, Surgical |
| Applicant | Wuhan Zonsen Medical Products Co.,Ltd No.8 Jinchao Road Zhucheng Street Xinzhou District Wuhan, CN 431400 |
| Contact | Cynthia Ye |
| Correspondent | Ivy Wang Shanghai Sungo Management Consulting Company Limited 14 Th Floor, 1500# Central Avenue Shanghai, CN 200122 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2021-09-08 |
| Decision Date | 2021-12-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850044458896 | K212861 | 000 |
| 10850044458889 | K212861 | 000 |
| 10850044458872 | K212861 | 000 |
| 10850044458865 | K212861 | 000 |