510(k) K002381

PENTAFERTE SINGLE USE SYRINGES, MODEL SIZE=VARIOUS SIZES by Pentaferte, S.R.L. — Product Code FMF

K002381 is an FDA 510(k) premarket notification submitted by Pentaferte, S.R.L. for the device "PENTAFERTE SINGLE USE SYRINGES, MODEL SIZE=VARIOUS SIZES". The FDA issued a decision of Substantially Equivalent on January 11, 2001. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Pentaferte, S.R.L. has at least 2 other 510(k) clearances on record.