510(k) K170578

True Function Adjustable Herbst Appliances by True Function Laboratory, Inc. — Product Code LRK

K170578 is an FDA 510(k) premarket notification submitted by True Function Laboratory, Inc. for the device "True Function Adjustable Herbst Appliances". The FDA issued a decision of Substantially Equivalent on Nov 24, 2017. The device falls under product code LRK (Device, Anti-Snoring), a Class II device regulated under 21 CFR 872.5570. True Function Laboratory, Inc. has 1 other 510(k) clearance on record.