510(k) K955684

RNS STERILE, DISPOSABLE ANGIOGRAPHIC TRAY by Contour Fabricators of Florida, Inc. — Product Code DXT

K955684 is an FDA 510(k) premarket notification submitted by Contour Fabricators of Florida, Inc. for the device "RNS STERILE, DISPOSABLE ANGIOGRAPHIC TRAY". The FDA issued a decision of Substantially Equivalent (kit) on May 2, 1996. The device falls under product code DXT (Injector And Syringe, Angiographic), a Class II device regulated under 21 CFR 870.1650. Contour Fabricators of Florida, Inc. has at least 10 other 510(k) clearances on record.