510(k) K955680

SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE; LONG CUFFED by Mallinckrodt Medical — Product Code JOH

K955680 is an FDA 510(k) premarket notification submitted by Mallinckrodt Medical for the device "SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE; LONG CUFFED". The FDA issued a decision of Substantially Equivalent on March 13, 1996. The device falls under product code JOH (Tube Tracheostomy And Tube Cuff), a Class II device regulated under 21 CFR 868.5800. Mallinckrodt Medical has at least 10 other 510(k) clearances on record.