510(k) K914268

I-125 SEEDS IN CARRIER, CODE: 6720 by Medi-Physics Inc. Dba Nycomed Amersham Imaging — Product Code KXK

K914268 is an FDA 510(k) premarket notification submitted by Medi-Physics Inc. Dba Nycomed Amersham Imaging for the device "I-125 SEEDS IN CARRIER, CODE: 6720". The FDA issued a decision of Substantially Equivalent on November 22, 1991. The device falls under product code KXK (Source, Brachytherapy, Radionuclide), a Class II device regulated under 21 CFR 892.5730. Medi-Physics Inc. Dba Nycomed Amersham Imaging has at least 8 other 510(k) clearances on record.