510(k) K042129

F00010 - IV GRAVITY SETWITH MALE LUER SLIP; F00027 - IV GRAVITY SET WITH MALE LUER LOCK by Cedic S.R.L. — Product Code FPA

K042129 is an FDA 510(k) premarket notification submitted by Cedic S.R.L. for the device "F00010 - IV GRAVITY SETWITH MALE LUER SLIP; F00027 - IV GRAVITY SET WITH MALE LUER LOCK". The FDA issued a decision of Substantially Equivalent on January 27, 2005. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Cedic S.R.L. has at least 6 other 510(k) clearances on record.