510(k) K032854

UNOMEDICAL MONICA INFUSION SET by Unomedical A/S — Product Code FPA

K032854 is an FDA 510(k) premarket notification submitted by Unomedical A/S for the device "UNOMEDICAL MONICA INFUSION SET". The FDA issued a decision of Substantially Equivalent on October 9, 2003. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Unomedical A/S has at least 10 other 510(k) clearances on record.