510(k) K945513

MALLINCKRODT SHILEY NEONATAL, PEDIATRIC, LONG PEDIATRIC TRACHEOSTOMY TUBE by Mallinckrodt Medical — Product Code JOH

K945513 is an FDA 510(k) premarket notification submitted by Mallinckrodt Medical for the device "MALLINCKRODT SHILEY NEONATAL, PEDIATRIC, LONG PEDIATRIC TRACHEOSTOMY TUBE". The FDA issued a decision of Substantially Equivalent on January 13, 1995. 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.