The following data is part of a premarket notification filed by Hangzhou Runheng Medical Co., Ltd. with the FDA for Medical Face Mask.
| Device ID | K213736 |
| 510k Number | K213736 |
| Device Name: | Medical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Hangzhou Runheng Medical Co., Ltd. Room 201, Shunfeng Building, NO.109 Hongxing Road, Qiaonan Block Hangzhou, CN 311215 |
| Contact | Yaya Lu |
| Correspondent | Yaya Lu Hangzhou Runheng Medical Co., Ltd. Room 201, Shunfeng Building, NO.109 Hongxing Road, Qiaonan Block Hangzhou, CN 311215 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-29 |
| Decision Date | 2022-03-31 |