510(k) K093773

AMSINO I.V. ADMINISTRATION SET, AMSAFE3 I.V ADMINISTRATION SET, EXTENSION SETS by Amsino International, Inc. — Product Code FPA

K093773 is an FDA 510(k) premarket notification submitted by Amsino International, Inc. for the device "AMSINO I.V. ADMINISTRATION SET, AMSAFE3 I.V ADMINISTRATION SET, EXTENSION SETS". The FDA issued a decision of Substantially Equivalent on March 10, 2010. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Amsino International, Inc. has at least 10 other 510(k) clearances on record.