510(k) K895770

EXEL HUBER INFUSION SET by Exel Intl. — Product Code FPA

K895770 is an FDA 510(k) premarket notification submitted by Exel Intl. for the device "EXEL HUBER INFUSION SET". The FDA issued a decision of Substantially Equivalent on July 19, 1990. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Exel Intl. has at least 10 other 510(k) clearances on record.