LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing— 510(k) K210718
Substantially EquivalentHuizhou Foryou Medical Devices Co., Ltd.
FDA 510(k) clearance K210718 for LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing, Substantially Equivalent on 2022-03-23. Applicant: Huizhou Foryou Medical Devices Co., Ltd..
Clearance details
- Applicant
- Huizhou Foryou Medical Devices Co., Ltd.
- Product code
- Code FRO
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Huizhou, CN
Adverse events under product code FRO
product code FRO- Death
- 30
- Injury
- 653
- Malfunction
- 479
- Other
- 11
- Total
- 1,173
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.