510(k) K962173

SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES by Mallinckrodt Medical — Product Code JOH

K962173 is an FDA 510(k) premarket notification submitted by Mallinckrodt Medical for the device "SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on October 4, 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.