510(k) K882430

HOOD TRACHEAL STOMA BUTTON by Hood Laboratories — Product Code BTO

K882430 is an FDA 510(k) premarket notification submitted by Hood Laboratories for the device "HOOD TRACHEAL STOMA BUTTON". The FDA issued a decision of Substantially Equivalent on June 28, 1988. 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.