The following data is part of a premarket notification filed by Xinxiang Kangbeier Medical Technology Co., Ltd. with the FDA for Kangbeier Surgical Mask (model: Kbr-1001).
| Device ID | K213920 |
| 510k Number | K213920 |
| Device Name: | Kangbeier Surgical Mask (Model: KBR-1001) |
| Classification | Mask, Surgical |
| Applicant | Xinxiang Kangbeier Medical Technology Co., Ltd. East Mancun Industrial District Changyuan, CN 48105 |
| Contact | Shaoju Tian |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2021-12-15 |
| Decision Date | 2022-01-16 |