510(k) K955687

RNS STERILE, DISPOSABLE RADIOGRAPHIC CONTRAST TRAY by Contour Fabricators of Florida, Inc. — Product Code JAA

K955687 is an FDA 510(k) premarket notification submitted by Contour Fabricators of Florida, Inc. for the device "RNS STERILE, DISPOSABLE RADIOGRAPHIC CONTRAST TRAY". The FDA issued a decision of Substantially Equivalent on June 3, 1996. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. Contour Fabricators of Florida, Inc. has at least 10 other 510(k) clearances on record.