Myflon Surgical Mask Level 3— 510(k) K212111

Substantially Equivalent

Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi

FDA 510(k) clearance K212111 for Myflon Surgical Mask Level 3, Substantially Equivalent on 2022-01-23. Applicant: Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi.

Clearance details

Applicant: Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2021-07-06
Decision date: 2022-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eskisehir, TR

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.