510(k) K955683

RNS STERILE, DISPOSABLE BREAST BIOPSY/LOCALIZATION TRAY by Contour Fabricators of Florida, Inc. — Product Code MJG

K955683 is an FDA 510(k) premarket notification submitted by Contour Fabricators of Florida, Inc. for the device "RNS STERILE, DISPOSABLE BREAST BIOPSY/LOCALIZATION TRAY". The FDA issued a decision of Substantially Equivalent on February 1, 1996. The device falls under product code MJG (Device, Percutaneous, Biopsy), a Class I device regulated under 21 CFR 878.4800. Contour Fabricators of Florida, Inc. has at least 10 other 510(k) clearances on record.