The following data is part of a premarket notification filed by Sample King Manufacturing Ltd with the FDA for Surgical Face Mask.
| Device ID | K210015 |
| 510k Number | K210015 |
| Device Name: | Surgical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Sample King Manufacturing Ltd Southwest Side Of The Intersection Of Mingzhu Boulevard And Shenyan Road, Yantian District Shenzhen, CN 518083 |
| Contact | Forest Cao |
| Correspondent | Forest Cao Sample King Manufacturing Ltd Southwest Side Of The Intersection Of Mingzhu Boulevard And Shenyan Road, Yantian District Shenzhen, CN 518083 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-04 |
| Decision Date | 2021-06-10 |