The following data is part of a premarket notification filed by Shandong Shengquan New Material Co., Ltd. with the FDA for Child Face Mask.
| Device ID | K201514 |
| 510k Number | K201514 |
| Device Name: | Child Face Mask |
| Classification | Pediatric/child Facemask |
| Applicant | Shandong Shengquan New Material Co., Ltd. Diaozhen Industrial Development Zone, Zhangqiu District, Jinan, CN 250204 |
| Contact | Xiumei Zhang |
| Correspondent | Shelley Li Shanghai Landlink Medical Information Technology Co., Ltd. Room 703, 705, Baohua International Plaza, West Guangzhong Road 555, Jingan Shanghai, CN 200071 |
| Product Code | OXZ |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-08 |
| Decision Date | 2021-10-10 |