510(k) K894409

CESIUM-137 MICROSEED SOURCE TRAIN ASSEMBLY/SHIELD by Amersham Corp. — Product Code IWA

K894409 is an FDA 510(k) premarket notification submitted by Amersham Corp. for the device "CESIUM-137 MICROSEED SOURCE TRAIN ASSEMBLY/SHIELD". The FDA issued a decision of Substantially Equivalent on September 29, 1989. The device falls under product code IWA (Source, Wire, Iridium, Radioactive), a Class II device regulated under 21 CFR 892.5730. Amersham Corp. has at least 10 other 510(k) clearances on record.