510(k) K972385

FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED by Smiths Industries Medical Systems, Inc. — Product Code JOH

K972385 is an FDA 510(k) premarket notification submitted by Smiths Industries Medical Systems, Inc. for the device "FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED". The FDA issued a decision of Substantially Equivalent on January 20, 1998. The device falls under product code JOH (Tube Tracheostomy And Tube Cuff), a Class II device regulated under 21 CFR 868.5800. Smiths Industries Medical Systems, Inc. has at least 10 other 510(k) clearances on record.