LM Surgical Mask Level 3, LM Surgical Mask Level 2,— 510(k) K211378
Substantially EquivalentLiberty Mask, LLC
FDA 510(k) clearance K211378 for LM Surgical Mask Level 3, LM Surgical Mask Level 2,, Substantially Equivalent on 2021-12-16. Applicant: Liberty Mask, LLC.
Clearance details
- Applicant
- Liberty Mask, LLC
- Product code
- Code FXX
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Richardson, TX, 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.