Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)— 510(k) K153409
Substantially EquivalentProtect U Guard, LLC
FDA 510(k) clearance K153409 for Protect U Guard Earloop and Tie-On Mask (Blue, White or Green), Substantially Equivalent on 2016-11-15. Applicant: Protect U Guard, LLC.
Clearance details
- Applicant
- Protect U Guard, LLC
- Product code
- Code FXX
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Safety Harbor, FL, 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.