510(k) K981797

B-D PEN ULTRA by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code FMF

K981797 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "B-D PEN ULTRA". The FDA issued a decision of Substantially Equivalent on June 12, 1998. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.