510(k) K131795

NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALS by Orfit Industries NV — Product Code IYE

K131795 is an FDA 510(k) premarket notification submitted by Orfit Industries NV for the device "NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALS". The FDA issued a decision of Substantially Equivalent on September 26, 2013. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Orfit Industries NV has at least 10 other 510(k) clearances on record.