F00010 - IV GRAVITY SETWITH MALE LUER SLIP; F00027 - IV GRAVITY SET WITH MALE LUER LOCK

About This 510(k) Submission

K042129 is an FDA 510(k) clearance for the F00010 - IV GRAVITY SETWITH MALE LUER SLIP; F00027 - IV GRAVITY SET WITH MALE LUER LOCK, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Cedic S.R.L. (Peschiera Borromeo, IT). The FDA issued a Cleared decision on January 27, 2005, 174 days after receiving the submission on August 6, 2004. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.