510(k) K002938

B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16 by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code FMI

K002938 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16". The FDA issued a decision of Substantially Equivalent on November 29, 2000. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.