The following data is part of a premarket notification filed by Chongqing Chaoke Industry Development Co., Ltd. with the FDA for Medical Face Mask.
| Device ID | K202714 |
| 510k Number | K202714 |
| Device Name: | Medical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Chongqing Chaoke Industry Development Co., Ltd. C31, Yangtze River Industry Park, Tea Garden New Zone, Nan'an District Chongqing, CN 400067 |
| Contact | Liu Xincheng |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai, CN 200120 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-16 |
| Decision Date | 2021-06-11 |