510(k) K051264

COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPS by Unomedical A/S — Product Code FPA

K051264 is an FDA 510(k) premarket notification submitted by Unomedical A/S for the device "COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPS". The FDA issued a decision of Substantially Equivalent on September 1, 2005. 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.