TIDI FACEMASK— 510(k) K100800

Substantially Equivalent

Tidi Products,Llc

FDA 510(k) clearance K100800 for TIDI FACEMASK, Substantially Equivalent on 2010-06-14. Applicant: Tidi Products,Llc.

Clearance details

Applicant: Tidi Products,Llc
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2010-03-22
Decision date: 2010-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Neenah, WI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FXX

product code FXX

Injury: 137
Total: 137

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.