510(k) K833398

MESULIN INSULIN INFUSION SET by Molnlycke A/S Hospital Products — Product Code FPA

K833398 is an FDA 510(k) premarket notification submitted by Molnlycke A/S Hospital Products for the device "MESULIN INSULIN INFUSION SET". The FDA issued a decision of Substantially Equivalent on March 6, 1984. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Molnlycke A/S Hospital Products has at least 2 other 510(k) clearances on record.