Single-use medical face mask— 510(k) K201974
Substantially EquivalentGuangdong Horigen Mother & Baby Products Co., Ltd.
FDA 510(k) clearance K201974 for Single-use medical face mask, Substantially Equivalent on 2021-03-07. Applicant: Guangdong Horigen Mother & Baby Products Co., Ltd..
Clearance details
- Applicant
- Guangdong Horigen Mother & Baby Products Co., Ltd.
- Product code
- Code FXX
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shantou, CN
Adverse events under product code FXX
product code FXX- Injury
- 137
- Total
- 137
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.