510(k) K853511

THE HOOD LIFE SAVER by Hood Laboratories — Product Code BTO

K853511 is an FDA 510(k) premarket notification submitted by Hood Laboratories for the device "THE HOOD LIFE SAVER". The FDA issued a decision of Substantially Equivalent on December 19, 1985. The device falls under product code BTO (Tube, Tracheostomy (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5800. Hood Laboratories has at least 10 other 510(k) clearances on record.