510(k) K120395

NERIA MULTI SUBCUTANEOUS INFUSION SET by Unomedical Devices S.A DE C.V. — Product Code FPA

K120395 is an FDA 510(k) premarket notification submitted by Unomedical Devices S.A DE C.V. for the device "NERIA MULTI SUBCUTANEOUS INFUSION SET". The FDA issued a decision of Substantially Equivalent on May 30, 2012. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440.