510(k) K192102

Thermoplastic Masks by Aktina Medical Corporation — Product Code IYE

K192102 is an FDA 510(k) premarket notification submitted by Aktina Medical Corporation for the device "Thermoplastic Masks". The FDA issued a decision of Substantially Equivalent on Sep 25, 2019. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Aktina Medical Corporation has 2 other 510(k) clearances on record.