510(k) K973107

AMSINO I.V. ADMINISTRATION SET by Amsino Intl., Inc. — Product Code FPA

K973107 is an FDA 510(k) premarket notification submitted by Amsino Intl., Inc. for the device "AMSINO I.V. ADMINISTRATION SET". The FDA issued a decision of Substantially Equivalent on October 2, 1997. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Amsino Intl., Inc. has at least 8 other 510(k) clearances on record.