IFM Surgical Mask Model SM3— 510(k) K202214

Substantially Equivalent

Fssc, LLC

FDA 510(k) clearance K202214 for IFM Surgical Mask Model SM3, Substantially Equivalent on 2021-03-02. Applicant: Fssc, LLC.

Clearance details

Applicant: Fssc, LLC
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2020-08-06
Decision date: 2021-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rensselaer, IN, 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.