The following data is part of a premarket notification filed by Tianjin Aoshang Outdoor Equipment Co., Ltd. with the FDA for Medical Surgical Mask.
| Device ID | K210030 |
| 510k Number | K210030 |
| Device Name: | Medical Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | Tianjin Aoshang Outdoor Equipment Co., Ltd. C-1-106, No.23 Xiangtan Road, Hongqiao District, Tianjin Tianjin, CN 300133 |
| Contact | Xiaoning Zhang |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box. 120-119 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 | 2021-01-05 |
| Decision Date | 2021-04-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06973532970018 | K210030 | 000 |
| 06973532970360 | K210030 | 000 |
| 06973532970216 | K210030 | 000 |
| 06973532970377 | K210030 | 000 |
| 06973532970049 | K210030 | 000 |
| 06973532970384 | K210030 | 000 |