510(k) K082212

SYRINGE WITH HANDI-FIL by Mallinckrodt Inc., Liebel-Flarsheim Business — Product Code DXT

K082212 is an FDA 510(k) premarket notification submitted by Mallinckrodt Inc., Liebel-Flarsheim Business for the device "SYRINGE WITH HANDI-FIL". The FDA issued a decision of Substantially Equivalent on January 22, 2009. The device falls under product code DXT (Injector And Syringe, Angiographic), a Class II device regulated under 21 CFR 870.1650. Mallinckrodt Inc., Liebel-Flarsheim Business has at least 7 other 510(k) clearances on record.