510(k) K212111

Myflon Surgical Mask Level 3 by Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi — Product Code FXX

K212111 is an FDA 510(k) premarket notification submitted by Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi for the device "Myflon Surgical Mask Level 3". The FDA issued a decision of Substantially Equivalent on Jan 23, 2022. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi has 1 other 510(k) clearance on record.