The following data is part of a premarket notification filed by Foshan Xinbao Technology Co., Ltd. with the FDA for Surgical Mask-models Cr02-2, Cr02.
Device ID | K202424 |
510k Number | K202424 |
Device Name: | Surgical Mask-Models CR02-2, CR02 |
Classification | Mask, Surgical |
Applicant | Foshan Xinbao Technology Co., Ltd. No. 20 Changjiang Road, Sanshan New Town, Nanhai District, Foshan City Foshan, CN 528251 |
Contact | Weishan Peng |
Correspondent | Cassie Lee Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District Guangzhou, CN 510700 |
Product Code | FXX |
CFR Regulation Number | 878.4040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-08-25 |
Decision Date | 2021-03-31 |