510(k) K822295

SURGI TEK'S DISPOS. INNER CANNULA FOR by Medical Engineering Corp. — Product Code BTO

K822295 is an FDA 510(k) premarket notification submitted by Medical Engineering Corp. for the device "SURGI TEK'S DISPOS. INNER CANNULA FOR". The FDA issued a decision of Substantially Equivalent on August 20, 1982. The device falls under product code BTO (Tube, Tracheostomy (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5800. Medical Engineering Corp. has at least 10 other 510(k) clearances on record.