The following data is part of a premarket notification filed by Qiqihar Hengxin Medical Supplies, Ltd. with the FDA for Single-use Surgical Mask With Ear Loop.
| Device ID | K201691 |
| 510k Number | K201691 |
| Device Name: | Single-Use Surgical Mask With Ear Loop |
| Classification | Mask, Surgical |
| Applicant | Qiqihar Hengxin Medical Supplies, Ltd. 10th Beijiang Road In Tiefeng Industrial Park, North Shuguang Ave. Tiefeng District Qiqihar, CN 161000 |
| Contact | Sihui Xiong |
| Correspondent | Ray Wang Beijing Believe-Med Technology Service Co., Ltd Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, CN 102401 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-22 |
| Decision Date | 2020-09-17 |