510(k) K955686

RNS, STERILE DISPOSABLE PERCUTANEOUS CHOLANGIOGRAPHIC TRAY by Contour Fabricators of Florida, Inc. — Product Code FRG

K955686 is an FDA 510(k) premarket notification submitted by Contour Fabricators of Florida, Inc. for the device "RNS, STERILE DISPOSABLE PERCUTANEOUS CHOLANGIOGRAPHIC TRAY". The FDA issued a decision of Substantially Equivalent on February 21, 1996. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Contour Fabricators of Florida, Inc. has at least 10 other 510(k) clearances on record.