The following data is part of a premarket notification filed by Shenzhen Safesecure Medical Infection Control Tech Co., Ltd with the FDA for Surgical Mask.
| Device ID | K213358 |
| 510k Number | K213358 |
| Device Name: | Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd 6A01, Block 1, Ahoke Plaza, Daling Community, Minzhi Street, Longhua District Shenzhen, CN 518109 |
| Contact | Patty Chen |
| Correspondent | Eva Li Shanghai Sungo Management Consulting Company Limited Room 1309, Dongfang Building, 1500# Century Ave Shanghai, CN 200122 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-12 |
| Decision Date | 2022-03-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06973563061815 | K213358 | 000 |