510(k) K924243

TRACHEOSTOMY CARE KIT by Transidyne General Corp. — Product Code JOH

K924243 is an FDA 510(k) premarket notification submitted by Transidyne General Corp. for the device "TRACHEOSTOMY CARE KIT". The FDA issued a decision of Substantially Equivalent (kit, denovo) on June 16, 1993. The device falls under product code JOH (Tube Tracheostomy And Tube Cuff), a Class II device regulated under 21 CFR 868.5800. Transidyne General Corp. has at least 10 other 510(k) clearances on record.