510(k) K832504

CRONEX LO-DOSE MAMMOGRAPHY by E.I. Dupont DE Nemours & Co., Inc. — Product Code IWZ

K832504 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "CRONEX LO-DOSE MAMMOGRAPHY". The FDA issued a decision of Substantially Equivalent on September 12, 1983. The device falls under product code IWZ (Film, Radiographic), a Class I device regulated under 21 CFR 892.1840. E.I. Dupont DE Nemours & Co., Inc. has at least 10 other 510(k) clearances on record.