510(k) K972854

PROTOS I.V. ADMINISTRATION SET (15 DROPS/ML) I4070S/(60 DROPS/ML)I4670S PRELIMINARY by Globe Ent., Inc. — Product Code FPA

K972854 is an FDA 510(k) premarket notification submitted by Globe Ent., Inc. for the device "PROTOS I.V. ADMINISTRATION SET (15 DROPS/ML) I4070S/(60 DROPS/ML)I4670S PRELIMINARY". The FDA issued a decision of Substantially Equivalent on December 17, 1997. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Globe Ent., Inc. has at least 4 other 510(k) clearances on record.