The following data is part of a premarket notification filed by Changzhou Combat Protective Equipment Co., Ltd. with the FDA for Nordiwell Medical Face Mask.
| Device ID | K202615 |
| 510k Number | K202615 |
| Device Name: | Nordiwell Medical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Changzhou Combat Protective Equipment Co., Ltd. QingSiTang Village, Henglin Town, Wujin District Changzhou, CN 213101 |
| Contact | Yanmei Song |
| Correspondent | Yanmei Song Changzhou Combat Protective Equipment Co., Ltd. QingSiTang Village, Henglin Town, Wujin District Changzhou, CN 213101 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-09 |
| Decision Date | 2020-12-31 |