510(k) K153010

Hudson RCI AquaPak Sterile Prefilled Nebulizers by Teleflexmedical, Inc. — Product Code CAF

K153010 is an FDA 510(k) premarket notification submitted by Teleflexmedical, Inc. for the device "Hudson RCI AquaPak Sterile Prefilled Nebulizers". The FDA issued a decision of Substantially Equivalent on July 26, 2016. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Teleflexmedical, Inc. has at least 10 other 510(k) clearances on record.