The following data is part of a premarket notification filed by Guangzhou Zhengkang Medical Equipment Co.,ltd with the FDA for Medical Surgical Mask.
| Device ID | K222204 |
| 510k Number | K222204 |
| Device Name: | Medical Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | Guangzhou ZhengKang Medical Equipment Co.,Ltd Room101, No.9 Nanling Zhongxin Kuang Road, Taihe Town Baiyun District GuangZhou, CN 510540 |
| Contact | Mike Wu |
| Correspondent | Riley Chen Feiying Drug & Medical Consulting Technical Service Group Rm 2401 ZhenYe International Center, No. 3101-90 Qianhai Road, Nanshan District Shenzhen, CN 518000 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-25 |
| Decision Date | 2022-09-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06973824910746 | K222204 | 000 |
| 06973824910722 | K222204 | 000 |
| 06973824910708 | K222204 | 000 |
| 06973824910685 | K222204 | 000 |
| 06973824910661 | K222204 | 000 |
| 06973824910647 | K222204 | 000 |