510(k) K842984

EXTENSION SET W/INJECTION SITE by Med Fusion Systems, Inc. — Product Code FPA

K842984 is an FDA 510(k) premarket notification submitted by Med Fusion Systems, Inc. for the device "EXTENSION SET W/INJECTION SITE". The FDA issued a decision of Substantially Equivalent on October 16, 1984. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Med Fusion Systems, Inc. has at least 10 other 510(k) clearances on record.