510(k) K960965

FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-0211 by Coeur Laboratories, Inc. — Product Code DXT

K960965 is an FDA 510(k) premarket notification submitted by Coeur Laboratories, Inc. for the device "FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-0211". The FDA issued a decision of Substantially Equivalent on September 12, 1996. The device falls under product code DXT (Injector And Syringe, Angiographic), a Class II device regulated under 21 CFR 870.1650. Coeur Laboratories, Inc. has at least 9 other 510(k) clearances on record.