3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield— 510(k) K180874
Substantially Equivalent3M Healthcare
FDA 510(k) clearance K180874 for 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield, Substantially Equivalent on 2018-07-31. Applicant: 3M Healthcare.
Clearance details
- Applicant
- 3M Healthcare
- Product code
- Code FXX
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Paul, MN, US
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.