510(k) K895420

SUCTION BIOPSY INSTRUMENT by Mill-Rose Laboratory — Product Code FCK

K895420 is an FDA 510(k) premarket notification submitted by Mill-Rose Laboratory for the device "SUCTION BIOPSY INSTRUMENT". The FDA issued a decision of Substantially Equivalent on February 9, 1990. The device falls under product code FCK (Instrument, Biopsy, Suction), a Class II device regulated under 21 CFR 876.1075. Mill-Rose Laboratory has at least 10 other 510(k) clearances on record.