510(k) K090300

MODIFICATION TO AUTOFUSER by Ace Medical Us, LLC — Product Code MEB

K090300 is an FDA 510(k) premarket notification submitted by Ace Medical Us, LLC for the device "MODIFICATION TO AUTOFUSER". The FDA issued a decision of Substantially Equivalent on April 30, 2009. The device falls under product code MEB (Pump, Infusion, Elastomeric), a Class II device regulated under 21 CFR 880.5725. Ace Medical Us, LLC has at least 1 other 510(k) clearance on record.