510(k) K897059

HOOD SPEAKING VALVE by Hood Laboratories — Product Code JOH

K897059 is an FDA 510(k) premarket notification submitted by Hood Laboratories for the device "HOOD SPEAKING VALVE". The FDA issued a decision of Substantially Equivalent on March 12, 1990. The device falls under product code JOH (Tube Tracheostomy And Tube Cuff), a Class II device regulated under 21 CFR 868.5800. Hood Laboratories has at least 10 other 510(k) clearances on record.