510(k) K800878

SECONDARY I.V. TUBING SETS by Harvard Laboratories — Product Code FPA

K800878 is an FDA 510(k) premarket notification submitted by Harvard Laboratories for the device "SECONDARY I.V. TUBING SETS". The FDA issued a decision of Substantially Equivalent on June 17, 1980. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Harvard Laboratories has at least 7 other 510(k) clearances on record.