510(k) K954749

MALLINCKRODT SHILEY 15MM CAP by Mallinckrodt Medical — Product Code JOH

K954749 is an FDA 510(k) premarket notification submitted by Mallinckrodt Medical for the device "MALLINCKRODT SHILEY 15MM CAP". The FDA issued a decision of Substantially Equivalent on January 24, 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.