510(k) K133528

H&H EMERGENCY CRICOTHYROTOMY KIT by H & H Medical Corporation — Product Code JOH

K133528 is an FDA 510(k) premarket notification submitted by H & H Medical Corporation for the device "H&H EMERGENCY CRICOTHYROTOMY KIT". The FDA issued a decision of Substantially Equivalent on July 3, 2014. The device falls under product code JOH (Tube Tracheostomy And Tube Cuff), a Class II device regulated under 21 CFR 868.5800.