510(k) K853419

CLEANING KIT CARE & CLEANING OF TRACHEAL T-TUBE by Hood Laboratories — Product Code BTO

K853419 is an FDA 510(k) premarket notification submitted by Hood Laboratories for the device "CLEANING KIT CARE & CLEANING OF TRACHEAL T-TUBE". The FDA issued a decision of Substantially Equivalent (with conditions) on December 6, 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.