510(k) K855130

TRACHEOSTOMY CARE KIT by Dynarex Corp. — Product Code BTO

K855130 is an FDA 510(k) premarket notification submitted by Dynarex Corp. for the device "TRACHEOSTOMY CARE KIT". The FDA issued a decision of Substantially Equivalent on March 4, 1986. The device falls under product code BTO (Tube, Tracheostomy (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5800. Dynarex Corp. has at least 10 other 510(k) clearances on record.