510(k) K190143

LARS AC Band Device by Corin USA — Product Code HTN

K190143 is an FDA 510(k) premarket notification submitted by Corin USA for the device "LARS AC Band Device". The FDA issued a decision of Substantially Equivalent on November 4, 2019. The device falls under product code HTN (Washer, Bolt Nut), a Class II device regulated under 21 CFR 888.3030. Corin USA has at least 10 other 510(k) clearances on record.