510(k) K023918

RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS by Rusch Intl. — Product Code JOH

K023918 is an FDA 510(k) premarket notification submitted by Rusch Intl. for the device "RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS". The FDA issued a decision of Substantially Equivalent on March 28, 2003. The device falls under product code JOH (Tube Tracheostomy And Tube Cuff), a Class II device regulated under 21 CFR 868.5800. Rusch Intl. has at least 10 other 510(k) clearances on record.