510(k) K153470

MADgic Laryngo-Tracheal Mucosal Atomization Device by Teleflex Medical — Product Code CCT

K153470 is an FDA 510(k) premarket notification submitted by Teleflex Medical for the device "MADgic Laryngo-Tracheal Mucosal Atomization Device". The FDA issued a decision of Substantially Equivalent on August 19, 2016. The device falls under product code CCT (Applicator (Laryngo-Tracheal), Topical Anesthesia), a Class II device regulated under 21 CFR 868.5170. Teleflex Medical has at least 10 other 510(k) clearances on record.